Avicenna.AI, a leading medical imaging AI company, has received Medical Device Regulation (MDR) certificate for five of its algorithms from certification body BSI Medical Devices. This development means the company’s product portfolio is fully compliant with the European Union’s MDR 2017/745, which is now mandatory for medical device companies that want to provide their solutions in Europe.

The MDR was introduced to update the EU’s regulations for medical devices, addressing safety issues and the recent emergence of AI tools and software as a medical device (SaMD), which did not exist when the old regulations were created. Ensuring MDR compliance is a critical component of obtaining and maintaining CE-mark status, which allows a device to be freely traded in the EU.

Compared to the previous Medical Device Directive (MDD), the MDR has a wider scope and more stringent requirements. It emphasizes clinical evaluation, post-market surveillance, device traceability, rigorous technical documentation, and risk management. These measures aim to enhance patient safety and ensure high standards for medical devices, including AI and software-based solutions.

Avicenna.AI’s products have been certified as Class IIb medical devices, which requires a high level of clinical validation. The certified products include the company’s suite of AI tools for neurovascular conditions, as well as its suite of algorithms for vascular conditions.

“Obtaining MDR certification is a significant milestone for Avicenna.AI,” said Stéphane Berger, Regulatory Manager at Avicenna.AI. “It demonstrates our commitment to meeting the highest standards of medical device safety and performance. This certification not only reinforces our dedication to compliance but also assures our customers of the quality and reliability of our AI product portfolio.”

The company’s MDR-certified AI tools include algorithms for intracranial hemorrhage (CINA-ICH), large vessel occlusion (CINA-LVO), quantification of stroke severity (CINA-ASPECTS), aortic dissection (CINA-AD), pulmonary embolism (CINA-PE), and opportunistic cases of pulmonary embolism (CINA-iPE). All the products are also CE-marked and FDA-cleared.

“Crucially, despite the differences in SaMD regulatory requirements between authorities in the US and Europe, we are consistently achieving both FDA and CE mark clearance for our AI products,” added Berger.

All of Avicenna.AI’s AI tools are seamlessly integrated into radiologists’ clinical workflow, automatically triggering and reporting algorithm results through the systems already used by radiologists.

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Azra AI, a healthtech leader harnessing artificial intelligence (AI) and workflow automation to accelerate the identification and treatment of cancer, is thrilled to announce the appointment of John Marshall as its new Chief Executive Officer. Marshall will succeed Chris Cashwell, who will continue to support Azra as an advisor. With more than 25 years of experience in technology and healthcare, Marshall brings deep expertise in market-leading strategies and first-to-market technologies to drive Azra AI’s growth in response to rising market demand.

Marshall, a visionary executive and accomplished sales leader, has a remarkable history of expanding domestic and global market channels through dynamic sales strategies, focused P&L discipline, driving product innovation, and unique team-building techniques. His leadership has guided several companies to the forefront of medical imaging, data management, and health IT.

“Given the increasing demand for AI-driven healthcare solutions, John Marshall is the ideal leader to propel Azra AI to new heights. His extensive expertise in both technology and healthcare, along with a proven track record of leadership, makes him uniquely qualified to steer the company through this exciting growth phase,” said Abinav Sankar, Chairman of the Board at Azra AI and partner at Sopris Capital. “I also want to express my gratitude to Chris Cashwell for his exceptional work in positioning Azra AI as a healthtech leader and setting the stage for a promising future.”

Marshall has a proven track record of bringing first-of-its-kind technologies to market, impacting healthcare systems, IDNs, diagnostic reading groups, pharma, and contract research organizations worldwide. His sales and executive leadership abilities include developing strategic sales and product plans, as well as recruiting dynamic teams that lead markets with best-of-breed partners and channel management.

Prior to joining Azra AI, John Marshall served as Chief Operating Officer at Enlitic, Inc., where he guided the company to a successful IPO in December 2023, starting from zero revenue and building global sales and marketing teams. As Global VP of Sales at Client Outlook, he was able to globally commercialize their technology to the point of an all-cash acquisition by Mach7 Technologies in 2020. Marshall’s leadership as Global VP of Sales at Calgary Scientific turned a start-up with no revenue or sales teams, into a multimillion-dollar global software provider.

“I’m excited to join the talented team at Azra AI and contribute to a mission that aligns so closely with my passion for leveraging technology to make a real difference in healthcare. Automatically identifying, classifying, and abstracting cancer diagnoses and incidental findings from pathology and radiology reports makes an enormously positive impact not only for oncology operations, but for patients and their ability to know about their cancer earlier, thus giving them a chance to survive and beat cancer. Together, we’ll push the boundaries of innovation at Azra, ensuring that our solutions continue to empower hospitals and cancer centers to provide the best care possible while enhancing operational efficiency, deep clinical outcomes, and capitalizing on real ROI. I could not be more excited and thankful for this opportunity,” said Marshall.

Azra AI’s enterprise SaaS platform revolutionizes oncology care with advanced AI-driven automation that transforms workflows, improves cancer navigation, and empowers healthcare providers to act swiftly on positive cancer diagnoses and suspicious incidental findings. With John Marshall’s strategic leadership and focus on expanding the platform’s innovative capabilities, Azra AI will continue to drive impactful improvements in operational efficiency, patient care, and service line growth across the healthcare industry.

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United Imaging, a global leader in manufacturing advanced medical imaging and radiotherapy equipment, will unveil its latest MRI technology, boasting incredible advancements across various fronts, as a Gold sponsor at this year’s ISMRM meeting.

The company’s exhibit at this year’s ISMRM meeting strategically divides into four sections: Ultra-High Field, Ultra-High Gradient, Artificial Intelligence, and Innovation Community. Each section addresses industry priorities and showcases sophisticated technological advancements.

“United Imaging has always been dedicated to pushing boundaries and driving innovation,” says Dr. Al Zhang, Ph.D, Chairman & Co-CEO. “ISMRM holds immense value for us, fostering connections with global partners who share our drive for progress. Our purposeful innovation drives scientific research forward, leading to groundbreaking advancements in healthcare technology. Guided by our mission, ‘Equal Healthcare for All,’ we remain committed to pioneering solutions that enhance patient care worldwide.”

At the forefront of the “Ultra-High Field” showcase is the uMR Jupiter 5T, a revolutionary whole-body 5T MRI system that recently received FDA clearance. It transcends the traditional constraints of ultra-high-field MRI, previously confined to imaging of the brain and selected MSK joints. The potential applications of the uMR Jupiter 5T extend to encompass the abdomen, heart, pelvis, and additional anatomical regions. uMR Jupiter has the potential to eclipse the capabilities of standard 3T MRI machines in resolution and signal-to-noise ratio, delivering clarity that empowers radiologists to uncover clinical details previously hidden, truly allowing them to ‘see the unseen.’ The uMR Jupiter 5T is also designed to overcome the key hurdles of ultra-high-field MRI: image uniformity and radio frequency safety. It fits into existing 3T MRI spaces, signaling a significant advancement in the industry.

Highlighted also in the “Ultra-High-Field” section is the “SuperFlexFree Coils” (not available in the U.S. or EU for commercial or clinical use). There are three types of coils in this set and all are 24 channels. Each is designed for scanning large joints and the heart, small joints, and delicate structures respectively. Compared to traditional coils, SuperFlexFree Coils have a significantly higher coil density and flexibility, which will result in better image signal-to-noise ratio and acceleration performance.

Additionally, United Imaging introduces breakthroughs in the “Ultra High Gradient” category, including the uMR Sagitta (not submitted to the FDA; not available in the U.S. for commercial or clinical use) and the uMR NX Frontier (not submitted to the FDA; not available in the U.S. for commercial or clinical use). uMR Sagitta completely revolutionizes the performance limits of magnetic resonance, achieving significant advances in global research in 3T systems. With the powerful ‘Twin-Engine technology’ driving force, its gradient performance surpasses 240 mT/m and 200 T/m/s, offering a fresh perspective in precise diagnosis and treatment. uMR NX Frontier (not submitted to the FDA; not available in the U.S. for commercial or clinical use), dedicated to brain research, serves as the new-gen model of Human Connectome Project (HCP) studies, boasting ultra-high-performance gradients of 650 mT/m and 600 T/m/s, leading a frontier exploration in neuroscience.

For the “Artificial Intelligence” section, United Imaging highlights the uAIFI Technology Platform, an innovative end-to-end technology platform that revolutionizes MRI through AI-integrated hardware and software. It significantly enhances image quality, expedites diagnostic processes and improves user-friendliness, pioneering advances in patient care. This holistic approach spans the care continuum, with standout features like ACS, an AI-assisted MR acceleration technology for enhanced 2D and 3D imaging. This platform evolved intelligently, bringing a new level of AI integration to uMR systems.

United Imaging has always been dedicated to advancing MRI research through collaboration with industry partners. The ADEPT platform – Application Developing Environment and Programming Tools — is a comprehensive platform offering essential features of precise hardware control and effortless application development. Coupled with extensive support for research platform interfacing and a vibrant scientific community, ADEPT marks a significant leap forward in accelerating user development and advancing scientific research in the field of MRI.

ISMRM attendees are invited to experience the future of MRI at Booth A18.

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PocketHealth, the leader in patient-centric medical image exchange, today announced it has raised $33 million USD ($45 million CAD) in Series B funding. The all-equity round was led by Round13 Capital with participation from Deloitte Ventures, Samsung Next, and existing investors Questa Capital and Radical Ventures.

The funding will enable PocketHealth to continue to evolve how medical images are shared, leverage AI to personalize the patient’s care journey, and grow its footprint across the US and Canada. To support these goals, the company plans to double its workforce over the next two years.

PocketHealth was founded in 2016 by brothers Harsh and Rishi Nayyar to give patients access, control, and a deeper understanding of their health records while streamlining the way healthcare providers share medical imaging.

“Medical imaging is the spark to nearly every patient journey, yet manual and legacy image sharing systems deemphasize patient access to their own data, generating unnecessary costs, and delaying patient care,” said Rishi Nayyar, Co-Founder and CEO, PocketHealth. “We’ve proven that when patients gain access to diagnostic-quality imaging and our industry-leading AI helps them understand their records, they are empowered to advocate for their care. The end result is increased patient satisfaction, a faster image sharing process for providers, and greater patient retention. Now, our goal is to make PocketHealth accessible to every patient at every provider across North America.”

With PocketHealth, providers gain a secure, next-generation platform for easily exchanging diagnostic images with both patients and external providers. Uniquely, PocketHealth customers have the flexibility to instantly share images with anyone, across any network — or set up a local network of PocketHealth Community Gateways for automated image exchange. This ensures that records get where they need to, instead of relying on a CD-ROM, return visits to the hospital, or a broken portal experience, which disrupts the patient’s care journey.

The platform uses AI to provide patients with personalized insights and improved understanding of their health. Report Reader explains medical terms in the patient’s report, Follow-Up Navigator intelligently detects follow-up imaging recommendations — encouraging patients to return for new imaging on-schedule — and MyCare Navigator equips patients with relevant, personalized questions to ask their doctor. As a result, 87% of patients surveyed say they are more likely to return to the same healthcare provider when they have access to their imaging through PocketHealth.

“For 20 years, medical image exchange has meant moving files across a closed network, from point A to point B,” said Nayyar. “We’re now seeing some of the largest health systems in North America expecting more from their image exchange and adopting PocketHealth to drive patient retention, satisfaction, and finally solve their image exchange needs.”

PocketHealth connected sites have seen improved patient experience, operational efficiencies, and cost savings.

• Colorado’s Valley View Hospital reduced non-labor costs associated with burning CDs by 95% and enabled patient and staff image sharing with out-of-network providers.
• Toronto’s Unity Health gained more than $120,000 in annual savings and closed their imaging library.

“PocketHealth is tackling a massive problem that requires the ability to build a thoughtful, resilient product experience for patients, physicians, and the most complex healthcare providers,” said Brahm Klar, Managing Partner, Round13 Capital. “We are impressed with how effectively the PocketHealth team has been able to rise to this challenge and create a solution that ensures data gets where it needs to go, instantly, empowering patients along the way. We are thrilled to join PocketHealth on this journey, and look forward to this exciting next stage of growth.”

Over its eight-year journey, PocketHealth has secured contracts with major health systems and outpatient imaging groups across North America including University Health Network, Southern Illinois Healthcare, UofL Health, Universal Health Services, Radiology Partners, and more. With this funding, the company has raised over $55.5 million USD ($75 million CAD) in equity to date. Miranda Ferris, Principal at Round13 Capital, will join the PocketHealth Board.

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Coreline Soft, a pioneer in medical artificial intelligence (AI) imaging, unveils cutting-edge AI medical imaging solutions at the ECR 2024 (European Congress of Radiology), establishing a new standard for healthcare across Europe. ECR, the largest radiology conference in Europe, attracts global experts and medical device industry professionals.

Coreline Soft is set to make a mark at the ECR 2024 by presenting its AVIEW product line. The exhibition will feature demonstrations of AVIEW LCS Plus for simultaneous diagnosis of chest diseases, AVIEW COPD for automatic analysis of chronic obstructive pulmonary disease, and AVIEW RT ACS, an AI-based fully automated contouring solution.

The showcase will encompass a comprehensive range of products from screening and diagnosis to treatment and management. Highlighting the AVIEW LCS Plus, capable of screening three major pulmonary conditions in CT scans, the presentation will focus on real-world applications in hospitals worldwide. The company will share insights into the benefits for medical professionals, workflow improvements, and enhanced diagnostic efficiency.

Coreline Soft has been actively expanding its presence in Europe, securing projects such as the multinational lung cancer screening initiative (iDNA) involving five European countries. Projects like the HANSE lung cancer screening in Germany and the ILSP lung cancer screening in Italy, led by the prestigious National Cancer Institute in Milan with 18 participating hospitals and cancer centers, showcase the company’s competitiveness in the global lung cancer screening market.

Having recently signed supply agreements with renowned institutions such as Heidelberg University Hospital in Germany, Catania University Hospital in Italy, and the large imaging center group ImaGen in France, Coreline Soft is poised to further extend its footprint in the European healthcare market.

Jason Seo, Director of Overseas Business Development at Coreline Soft, said, “We have accumulated expertise in entering local hospitals and national-level projects, positioning the European market as a forward base for the global market.”

Coreline Soft continues to strengthen its global presence, offering innovative AI solutions to advance healthcare practices in Europe and beyond.

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To read the US and global reports, visit: 
https://klasresearch.com/report/2024-best-in-klas-awards-software-and-services/3413
https://klasresearch.com/report/2024-best-in-klas-awards-global-software/3414

“These awards showcase our excellent employees who continuously go above and beyond to meet customer needs. Over the past year, we have restructured our organization into teams to ensure consistent and knowledgeable guidance throughout the sales, implementation, and support phases of the customer journey. This, along with product offerings that reduce IT costs, increase security, and grow with our users’ enterprise imaging requirements, has solidified our success,” says Marie Ekström Trägårdh, Executive Vice President Sectra AB and President Sectra Imaging IT Solutions.

Sectra 2024 Best in KLAS honors include US Large PACS, US Small PACS, PACS Global (Canada), PACS Global (Northern Europe), and PACS Global (Southern Europe). 

The first Sectra PACS installation was in Sweden in 1993, and now, the company has more than 2,500 sites worldwide. The radiology module is an integral part of Sectra’s enterprise imaging solution, also comprising VNA and imaging modules for cardiology, orthopedics, ophthalmology, and digital pathology in one single system.

Adam Gale, CEO of KLAS shared his thoughts for the 2024 winners:
“At KLAS, we firmly believe that the voice of healthcare providers and payers is paramount. The Best in KLAS awards are based on extensive feedback and evaluations from healthcare professionals across the nation. Winning a Best in KLAS award, therefore, is not just about recognition; it shows the trust and confidence that healthcare providers place in the winning vendors. It also helps validate each vendor’s commitment to innovation, quality, and customer satisfaction. We are proud to recognize 2024’s Best in KLAS award winners! Their unwavering dedication to improving patient outcomes is wonderfully inspiring.” 

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Intelerad Medical Systems, a global leader in medical imaging software solutions, was recognized as a 2024 Best in KLAS: Global Software Report award winner. The company has earned its recognition as the 2024 Best in KLAS vendor for the UK and Ireland PACS, leading the category across both regions based on provider and payers’ feedback in 2023.

Intelerad’s InSight PACS is a tailor-made PACS solution that has been adopted by over 250 healthcare providers across the UK and Ireland. The technology features a single, powerful interface for all users, and offers advanced functionality that delivers key clinical benefits such as advanced regional image sharing and MDT support, home reporting and teleradiology, and seamless integration with AI algorithms. The innovative PACS offering is a critical resource for UK healthcare professionals, who are facing an ageing and growing population, and a shortage of radiologists in addition to challenges around costs of healthcare.

“The demand for better technology that can drive essential workflow efficiencies for healthcare providers and help solve industry issues is greater than ever. Intelerad’s InSight PACS is a solution that is built and refined by UK professionals for UK clinicians who understand the needs and challenges standing in the way of better care outcomes,” said Morris Panner, President, Intelerad. “Receiving this recognition by KLAS as the number one leader in UK and Ireland PACS for 2024 is an incredible honour, and we will continue investing in this critical technology to better serve healthcare providers and the patients they serve.”

As the most comprehensive report of its kind in the healthcare IT industry, the annual 2024 Best in KLAS: Global Software Report recognizes vendors for their outstanding efforts to help healthcare professionals deliver better patient care. Using KLAS’ research process and methodology, all rankings are a direct result of the feedback from thousands of providers over the last year. A Best in KLAS award determines the standard of excellence that the top vendors should provide in a partnership.

“At KLAS, we firmly believe that the voice of healthcare providers and payers is paramount. The Best in KLAS awards are based on extensive feedback and evaluations from healthcare professionals across the nation. Winning a Best in KLAS award, therefore, is not just about recognition; it shows the trust and confidence that healthcare providers place in the winning vendors,” said Adam Gale, CEO, KLAS Research. “It also helps validate each vendor’s commitment to innovation, quality, and customer satisfaction. We are proud to recognize 2024’s Best in KLAS award winners! Their unwavering dedication to improving patient outcomes is wonderfully inspiring.”

A sample of feedback from the providers who use Intelerad’s InSight PACS and participated* in the KLAS research process is included below.

“The vendor has good customer support in the UK. The product is reliable with very few, if any, unplanned instances of downtime. The product is easy to use.” – Manager, September 2023

“The vendor’s biggest strengths and the things we like most are the desktop support and the trainer knowledge and that the network team is all very knowledgeable. InSight PACS and our other PACS work well together and are reliable. The Intelerad system is adequate for breast screening images, and it manages tomosynthesis images well and is easy to use. The consultants are happy with the product when reading images.” – Manager, September 2023

“InSight PACS Is a user-friendly product, and the vendor has an excellent support team for when something isn’t working properly.” – Manager, September 2023
*Selected commentary collected about Intelerad’s InSight PACS © 2023 KLAS. Visit klasresearch.com for a complete view.

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Visage Imaging, Inc. (“Visage”), a wholly owned subsidiary of Pro Medicus Ltd. (ASX: PME), has announced the launch of the groundbreaking Visage Ease VP for Apple Vision Pro, Apple’s highly anticipated spatial computing platform released today.

Designed to take advantage of the unique capabilities of Apple Vision Pro, Visage Ease VP supports immersive, spatial experiences for diagnostic imaging and multimedia. Visage Ease VP includes all the proven functionality of Visage Ease, plus the exciting addition of Visage’s powerful cinematic rendering engine for stunning volume-rendered images in immersive space. Anywhere, on-the-go access with Visage Ease VP has additional flexibility with virtual screens at more than 4K resolution per eye, the independence from environmental lighting restrictions, and the ability to interact with imaging seamlessly in your physical space. Visage Ease VP uses the natural and intuitive input of eyes, hands, and voice navigation to provide an end-user imaging experience that’s magical and unlike any other application.

UC San Diego Health is the first health system to pilot the technology. “The visualization of three-dimensional medical imaging in immersive space creates exciting opportunities to improve patient care,” said Dr. Paul Murphy, associate clinical professor at UC San Diego School of Medicine and radiologist at UC San Diego Health. “Technology that allows for sophisticated eye motion and gesture controls for reviewing 2D and 3D medical imaging could potentially help in efficient tumor board reviews and create collaborative spaces in healthcare.”

Today’s launch of Visage Ease VP signals just the beginning and ushers in a new era of spatial imaging and workflow possibilities.

“Visage’s platform of enterprise imaging applications that support the Apple ecosystem are used by many of the world’s largest, most sophisticated healthcare organizations, and also integrated bi-directionally to the most widely used EHR,” said Malte Westerhoff, PhD, Visage co-founder and global chief technology officer.

Visage Ease VP (visionOS) is the latest member of the Visage Ease family of native apps purpose-built for the Apple ecosystem, joining Visage Ease (iOS/iPadOS) and Visage Ease Pro (iPadOS). Visage also offers the acclaimed Visage 7 smart-client application for macOS, providing native, ultrafast, clinically rich, highly interoperable access to enterprise imaging.

Visage Ease VP is exclusively intended for use by Visage customers on the industry-leading Visage^® 7 Enterprise Imaging Platform, version Visage 7.1.18h (or higher). Visage Ease VP is available for download via the Apple App Store.

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GE HealthCare (Nasdaq: GEHC) today announced it has entered into an agreement to acquire MIM Software, a global provider of medical imaging analysis and artificial intelligence (AI) solutions for the practice of radiation oncology, molecular radiotherapy, diagnostic imaging, and urology at imaging centers, hospitals, specialty clinics, and research organizations worldwide. GE HealthCare expects to leverage MIM Software’s imaging analytics and digital workflow capabilities across various care areas to accelerate innovation and differentiate its solutions for the benefit of patients and healthcare systems around the world.

Recognizing the industry transformation taking place as digital innovation reshapes the experience of patients and providers, GE HealthCare – a leading global medical technology, pharmaceutical diagnostics, and digital innovator – is focused on developing smart devices, aligned to disease states and enabled by digital. These efforts are reflected in the company’s mission to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier.

MIM Software’s portfolio of innovative imaging solutions provides a variety of beneficial features, including: the integration of diagnostic images from multiple modalities into treatment plans; automation to help reduce repetitive tasks and manual interventions; quantitation and advanced processing in diagnostic imaging and nuclear medicine to help determine therapy response; and a platform to assist with Theranostics imaging and dosimetry.

GE HealthCare expects to integrate MIM Software solutions into its advanced visualization offerings to facilitate AI-based segmentation and contouring as well as dosimetry analysis for patients across their treatment journeys and in the growing fields of radiology, molecular imaging, and radiation oncology.

“We are committed to providing comprehensive, connected devices and digital solutions that enable providers to improve patient care across multiple specialties,” says Peter Arduini, President & CEO of GE HealthCare. “We expect our efforts to bring these two complementary organizations and innovative product portfolios together to strengthen our capabilities as a leading provider of integrated imaging systems, analytics, and advanced digital workflows across several care areas and pathways – including Theranostics, radiation oncology, urology, neurology and cardiology. Now and in the future, we are working to transform patient care.”

“We are excited by the prospect of joining GE HealthCare and thrilled to share this exciting news,” adds Andrew Nelson, CEO of MIM Software. “Over the past two decades, we have worked to develop innovative vendor agnostic products and deliver quality services to earn the trust of our customers – this will not change. As a part of GE HealthCare, we anticipate developing new and increasingly integrated digital solutions to meet our customers’ most complex and pressing needs, today and into the future. Together, we will build upon our shared legacies of enhancing patient care.”

As novel therapies become more widely available, providers rely on advanced imaging, workflow and digital solutions to provide critical information and help enable faster, more effective treatment plans. With the agreement to acquire MIM Software, GE HealthCare is working towards strengthening its focus and offerings to support the broad practice of precision care across various disease states and imaging practices, including Theranostics in oncology for the treatment of advanced prostate cancer, streamlined workflow solutions in radiation oncology to help simplify complex cancer treatment plans, beta amyloid imaging in neurology for the diagnosis and monitoring of Alzheimer’s patients, and myocardial perfusion to diagnose coronary artery disease (CAD).

“Our anticipated acquisition of MIM Software will mark a key moment in the evolution of our technology. By integrating MIM Software’s cutting-edge imaging analytics and AI-driven solutions with GE HealthCare’s advanced medical technology, we are not just expanding our capabilities, but joining together to embrace the possibilities of precision care. This intended merger is a fusion of innovative visions, aimed at evolving the way we detect, treat, and manage disease,” shares Taha Kass-Hout, MD, MS, Chief Technology Officer of GE HealthCare. “GE HealthCare is committed to developing smart, AI-powered devices that cater to specific disease states, thereby enabling clinicians to deliver more personalized care. We expect the integration of MIM Software will also advance our efforts in connecting data across care pathways. It is a leap towards a future where healthcare is more precise, connected, and efficient, with the goal of benefitting providers and patients worldwide.”

Founded in 2003, MIM Software is headquartered in Cleveland, Ohio, with additional offices in China and Belgium. The consummation of the transaction is subject to customary closing conditions, including regulatory approvals. Financial details of the transaction have not been disclosed publicly. GE HealthCare intends to fund this transaction with cash on hand. The Company expects this transaction to be neutral to Adjusted EBITⁱ in year one and accretive thereafter.

Forward-Looking Statements

This release contains forward-looking statements. These forward-looking statements might be identified by words, and variations of words, such as “will,” “expect,” “may,” “would,” “could,” “plan,” “believe,” “anticipate,” “intend,” “estimate,” “potential,” “position,” “forecast,” “target,” “guidance,” “outlook,” and similar expressions. These forward-looking statements may include, but are not limited to, statements about the transaction, the completion and expected results of the transaction, and GE HealthCare Technologies Inc.’s (the “Company’s”) performance, growth opportunities, and strategy. These forward-looking statements involve risks and uncertainties, many of which are beyond the control of the Company. Factors that could cause the Company’s actual results to differ materially from those described in its forward-looking statements include, but are not limited to, the conditions to the completion of the transaction may not be satisfied; closing of the transaction may not occur or may be delayed; the Company may be unable to achieve the anticipated benefits of the transaction; operating costs and business disruptions (including, without limitation, difficulties in maintaining relationships with employees, customers, and suppliers) may be greater than expected; the Company may assume unexpected risks and liabilities; and completing the transaction may distract the Company’s management from other important matters. Other factors that may cause such a difference also include those discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission and any updates or amendments it makes in future filings. There may be other factors not presently known to the Company or which it currently considers to be immaterial that could cause the Company’s actual results to differ materially from those projected in any forward-looking statements the Company makes. The Company does not undertake any obligation to update or revise its forward-looking statements except as required by applicable law or regulation.

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Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, today announced its proposal to acquire Volpara Health Technologies Ltd. (Volpara; ASX:VHT), a global leader in AI-enabled software for the early detection and prevention of cancer. The strategic move comes as a result of an exhaustive evaluation of potential avenues for growth and innovation by Lunit.

Following the decision, Lunit and Volpara have entered into a Scheme Implementation Agreement, under which Lunit will acquire all of Volpara’s shares at a price of AUD 1.15 per share through a New Zealand scheme of arrangement (Scheme).

“Lunit’s acquisition of Volpara signifies a pivotal moment in our commitment to advancing global cancer diagnostics. Volpara’s AI-powered mammography solutions, operational in over 2,000 U.S. medical sites, would catapult Lunit into the forefront of the American market,” said Brandon Suh, CEO of Lunit. “What sets Volpara apart is not just its market presence but the depth of knowledge embedded in its development process. With a robust repository of over 100 million high-quality mammogram images, Volpara’s contribution would supercharge Lunit’s AI capabilities, paving the way for groundbreaking solutions in medical imaging. This alliance would position us to lead innovation in cancer diagnostics and therapeutics, benefitting healthcare professionals and patients alike.”

The Scheme is contingent upon Volpara shareholders’ and New Zealand High Court’s approval, regulatory clearances from the New Zealand Overseas Investment Office, and fulfillment of other customary conditions outlined in the Scheme Implementation Agreement. Shareholders are expected to cast their votes at a Scheme meeting in the early second quarter of 2024. Subject to the successful completion of these steps, Lunit anticipates finalizing the acquisition by the end of the second quarter of 2024.

Key Highlights of Acquisition:

The cash offer of AUD 1.15 per share represents a compelling 47.4% premium to Volpara’s last closing share price of AUD 0.78 per share on December 13th. Lunit is set to acquire a total of 254 million shares, translating to a deal worth about AUD 292 million (USD 193 million).

The Scheme Implementation Agreement contains customary exclusivity provisions. These restrictions are subject to exclusions which permit the Volpara Board to engage on a competing proposal which is (or is reasonably capable of becoming) a superior proposal and where it is necessary to respond to such proposal to fulfill statutory or fiduciary obligations. This is subject to notifications being made to Lunit with an opportunity to match any superior proposal.

“Volpara’s Board has assessed the proposed Scheme as providing compelling, risk-adjusted value and certainty for shareholders and unanimously support the proposed transaction,” said Paul Reid, Volpara Chairman. “In considering options for Volpara, including continuing to implement the Company’s growth strategy as a publicly-listed company, the Board adopted a long-term view of the risks and rewards of various alternatives. While the Board remains confident in the future of Volpara, the transaction would accelerate a capital return to shareholders and mitigates the risks that would otherwise be involved in delivering the opportunities from executing Volpara’s strategic plan over time.”

“Lunit’s proposal to acquire Volpara is a testament to the high quality of our products, our significant US market presence and the hard work of our employees. By combining Lunit and Volpara, the Group would have the opportunity to develop products that no other company is in a position to do. This is expected to put the combined company at the forefront of cancer technology and position it as a global leader in our field,” said Teri Thomas, CEO and Managing Director of Volpara.

“Lunit and Volpara are unified in our belief in the power of AI-driven software and together, our two organizations have the potential to create a powerful engine to better diagnose and care for cancer worldwide. Combining Volpara’s established presence in the US with Lunit’s complementing global footprint and AI expertise will create a compelling portfolio of advanced AI-enabled solutions for radiology and for other healthcare specialties,” added Brandon. “We respect and admire the achievements and corporate culture that Volpara has built and believe that together we can accelerate the entry of meaningful products to market that would save lives and benefit medical practices as we jointly pursue our shared vision of conquering cancer through AI.”

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