Amba Health and Care, a leader in advanced senior care technology, is proud to announce its partnership with PacSana, a cutting-edge health and safety wearable for older adults. This strategic partnership aims to elevate care standards for residents and drive growth by enhancing care efficiencies for senior healthcare providers. 

Amba Health and Care’s leading-edge care delivery platform leverages AI automation to provide real-time insights into sleep and activity, mobility and wandering, gait, and other wellness indicators. This enables precise, proactive care notifications, allowing senior living operators to deliver timely resident checks and care interventions. By optimizing staff resources and reducing unnecessary tasks, Amba’s solution not only enhances care quality but also significantly lowers operational costs.

“We strive to prevent adverse health events, particularly falls and hospitalizations,” says Ernie Ianace, President of Amba Health and Care. “PacSana’s advanced wearable technology offers precise gait analysis, detecting subtle decreases in gait speed that signal an increased risk of falls and potential cognitive decline. Through advanced AI, Amba Health identifies and analyzes these critical indicators to enhance resident safety and well-being.”

PacSana, The Smart Solution for Safe Aging, elevates care with a custom-designed smart bracelet paired with innovative sensor technology. This bracelet collects detailed data and insights on daily activities, exercise, gait, falls, and more, building a precise understanding of care needs both within and outside the home. With actionable insights, PacSana guides caregivers on the right care, when it’s required, and at the most appropriate location. It’s simple enough for ease of use, yet powerful enough to create an immediate impact.

“Sharing a common mission for improving care across the aging continuum, we are very excited to partner with Amba,” says Feargal Duignan, CEO of PacSana. “This partnership will extend our ability to serve even more seniors and their caregivers across the United States.” 

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Frost & Sullivan has named Evidation the 2024 Honoree of the Best Practices Customer Value Leadership Award for Real-World Evidence Solutions in Healthcare. Frost & Sullivan recognizes Evidation’s transformative approach in harnessing consented real world data directly from individuals to deeply characterize and understand health and disease.

Evidation’s research solutions allow healthcare and life sciences organizations to connect directly with individuals to better measure, understand, and improve health. Evidation uses data from wearables, surveys, and electronic patient-reported outcomes (ePROs) to get a more complete picture of symptoms, disease progression, treatment impact, quality of life, and social determinants of health. Through its decentralized approach and ability to engage millions over the long term, Evidation is reimagining health research to make it faster, more precise, more inclusive, and more transparent.

“Evidation’s dedication to patient-centricity transcends mere rhetoric, and focuses on respect for problems, people, and customers. The emphasis on ‘real’ RWD sets it apart, providing a holistic understanding beyond conventional EHR and claims data,” said Ojaswi Rana, Best Practices Research Analyst. “This approach broadens the focus from patients to at-risk and healthy individuals, contributing to a more nuanced perspective on health and disease.”

The Evidation app is used by a community of almost 5 million people in 97% of U.S. ZIP codes, who are rewarded for engaging in healthy activities and contributing to health research; over one million individuals have participated in research on Evidation. Members earn points, which can be redeemed for cash or charitable donations, by tracking activities like walking, sleeping, and logging food and for participating in research surveys and studies. Evidation prioritizes transparency and consent by always obtaining user permission for data use and sharing. Participants can opt-in to sharing additional health data with researchers, including pharmacy claims and electronic health record data.

“Evidation’s large, highly characterized, and responsive population ensures rapid access to diverse data for bespoke data collection. Its direct, two-way connection with members also enables customers to quickly re-contact patients for follow-up questions and contextualize data sets,” said Unmesh Lal, Research Director at Frost & Sullivan. “The company’s technology platform is also a differentiator, due to its success in driving high engagement and protocol adherence rates at scale over long periods.”

Evidation’s solutions include:

• Recruitment: Recruit directly from Evidation’s engaged, diverse community to rapidly enroll individuals into research.
• Research: Deploy Evidation’s retrospective and prospective research solutions to measure health in everyday life.
• Platform: License Evidation’s platform to conduct long term, digitally enabled, direct-to-participant research programs.

The Best Practices Customer Value Leadership Awards is part of Frost & Sullivan’s ongoing effort to identify visionary companies at the forefront of innovation and growth. For more information on Evidation’s health research solutions, please visit evidation.com.

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Masimo (NASDAQ: MASI), today announced that the Masimo W1^® Sport advanced health tracking wearable is gaining a powerful new feature: scientifically based sleep analysis with Sleep Halo. Sleep Halo offers overnight sleep data tracking with an unmatched 70,000+ daily measurements of second-by-second continuous health data.

Sleep Halo uses continuous Masimo pulse oximetry and machine learning to provide meaningful insights into the quality of an individual’s sleep, including overall timing, duration of sleep stages, periods of rest and wakefulness, episodes of desaturation, and more. The nightly analysis, including a Sleep Halo score – an algorithmic calculation representing your overall sleep quality – is visualized on the companion Masimo Health smartphone app. The Sleep Halo score and sleep analysis will be featured in all future Masimo wearables, including the upcoming Masimo Freedom Watch and Band.

Joe Kiani, Founder and CEO of Masimo, said, “We’re truly excited to launch Sleep Halo for Masimo W1 Sport. For 35 years, Masimo has been dedicated to using breakthrough engineering to help improve lives. Masimo W1 is unique among wearables in being able to continuously measure the wearer’s SpO₂ and PR – and that gives us an opportunity to provide a truly informed, robust analysis of how one sleeps. As always, we are committed to providing scientifically backed measurements, which are based on our unmatched, accurate technology, not ‘tarot card logic’ novelties. We benchmarked Sleep Halo with EEG to confirm its stages of sleep are comparable to sleep analysis. We hope that with this new scientifically based Sleep Halo, our customers can improve their sleep hygiene, which has been shown to improve life.”

Today’s consumers are limited to choosing from among a variety of consumer wearables, which use intermittent and often inaccurate data, heavily reliant on movement – which cannot provide reliable or actionable sleep metrics. Masimo W1 – which has been shown to be significantly more accurate than the leading consumer wearable¹ – is designed to provide sophisticated and insightful sleep analysis using technology based on Masimo SET^®, the primary pulse oximetry technology at all top 10 U.S. hospitals as ranked in the 2024 Newsweek World’s Best Hospitals listing.² Rigorously tested against reference laboratory measurements, including EEG data, Sleep Halo makes it possible to bring reliable, insightful sleep analysis to everyday people around the world, on a nightly basis, via a lightweight, comfortable wearable, from the convenience of their own home.

Existing Masimo W1 Sport owners will soon be able to update their watch firmware and Masimo Health app to begin their sleep tracking journey. Masimo W1 is available for purchase at www.Masimo.com.

Also available is Masimo W1 Medical, the first and only FDA-cleared watch to provide continuous, real-time SpO₂ and PR with an indicator when measurements are outside of their normal ranges.

Masimo W1 Sport and Sleep Halo are for general health and wellness purposes.

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Nihon Kohden, renowned for its history of excellence in providing innovative high quality, reliable medical technology that improves the way healthcare is practiced, is partnering with Medasense to introduce its nociception monitor to the Japanese market. This cutting-edge device, with its state-of-the-art AI powered NOL – Nociception Level Index®, provides real-time, objective pain monitoring, enabling the personalization and optimization of pain treatment. It will be accessible to hospitals and clinics throughout Japan through Nihon Kohden’s extensive distribution channels pending regulatory approval.

Medasense’s CEO & Founder, Galit Zuckerman, expressed enthusiasm about the collaboration: “We are honored to partner with Nihon Kohden, a company with a long history of excellence, that shares our vision of improving patient care through innovative solutions. Our mission is to help all patients suffer less from pain and the adverse effects of pain medication. Nihon Kohden’s established clinical, technological leadership and expertise in the Japanese market make them the perfect partner to distribute our nociception monitor.”

NOL monitoring provides an AI powered, clinically validated index to objectively quantify the physiological response to pain (nociception) supporting clinicians in delivering personalized anesthesia tailored to patient requirements. With over 40 peer reviewed publications, clinical studies have demonstrated that NOL-guided analgesia resulted in intraoperative opioid sparing, and improved post operative pain scores and patient recovery.^1,2

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JOGO Health (JOGO), a medtech company treating chronic pain and neuromuscular disorders, announced it has closed over $5.5 million in an investment round led by Hourglass Ventures. Due to high demand, the company is opening the round to public retail investors via a Regulation CF community investment round on Wefunder, inviting retail investors to join alongside firms like Mayo Clinic Ventures, the venture arm of the world-renowned hospital.

JOGO’s wearable technology and app leverage the brain’s natural neuroplasticity to provide non-invasive, drug-free relief for conditions including chronic lower back pain, stroke recovery, migraines, and incontinence. Cleared by the FDA and reimbursed by Medicare and commercial insurance, JOGO is expanding a $380B market without drugs or surgery, supported by 18 patent claims across all neuromuscular conditions. JOGO has already treated 25,000+ patients across 50+ hospital channel partners, including Mayo Clinic, Mount Sinai Hospital, and Brigham and Women’s Hospital.

Led by a team of accomplished healthcare entrepreneurs, JOGO’s team brings experience from Columbia University, Harvard University, Yale University, AT&T, Johnson & Johnson, and Astrazeneca. Co-Founder and CEO Sanjai Murali built JOGO from zero to FDA market authorization. Siva Nadarajah, President and Co-Founder, previously sold an AI healthcare startup to leading clinical research company IQVIA, delivering a 10x return to investors.

“The conviction of our investors is phenomenal,” added Siva Nadarajah, President and Co-Founder. “This round will enable us to meet growing demand.”

“We believe healthcare is too important to be controlled by a few,” said Sanjai Murali, CEO and Co-Founder. “JOGO is founded on the vision of ‘by the world, for the world,’ and opening our investment round to retail investors on Wefunder is a crucial step towards realizing this vision.”

Capital raised will support JOGO’s commercial launch, putting JOGO on track to become the first line of treatment for chronic pain and other neuromuscular disorders – impacting 1 in 5 people globally. The community investment round is open to everyone via Wefunder, with a minimum investment of $100.

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The AR Alliance announces that Google will become the next founding member with a seat on the board of directors.

The AR Alliance provides a supportive and neutral environment for organizations of all sizes to take an active role in advancing and strengthening the augmented reality hardware development ecosystem. Diverse organizations across the expanding, global AR ecosystem work together through the AR Alliance to speed innovation of breakthrough technologies and processes for building AR wearables and devices that create a meaningful and positive experience for users.

“We are building AR together,” said Dr. Bharath Rajagopalan, chair, AR Alliance, and director of strategic marketing, STMicroelectronics. “The promise of AR and its potential market are so vast that there is ample room for all our member companies to succeed together. The AR Alliance is the place where concrete work takes place to harmonize approaches for advancing, unifying, and growing the global AR supply chain and accelerating innovation. We are excited for Google to join us in this important work and bring their technology leadership, deep market understanding and unique market experiences and perspectives to help propel the AR market.”

Steve Goldberg, Director, Next-Gen HW/SW Platforms, at Google added “Our mission is to organize the world’s information and make it universally accessible and useful. AR technologies, like those the AR Alliance is working on, have the potential to transform how we interact with information by blending our physical and digital worlds. We look forward to partnering with AR Alliance and its members to continue exploring the possibilities of AR and how it can be harnessed to solve real-life everyday challenges.”

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Element Materials Technology (Element), a leading global provider of testing, inspection, and certification (TIC) services, today announced the launch of Element RegNav (RegNav), its first artificial intelligence (AI)-powered regulatory intelligence platform for medical devices. Initially launched to support FDA regulatory pathways, RegNav will help bring medical innovations to market safely and more reliably for those in need.

RegNav’s proprietary software combines AI with expert guidance to support medical device manufacturers in identifying the regulations, standards, requirements, and testing needed to support the FDA submission process. Currently, bringing a medical device to market is a lengthy procedure with manufacturers facing a complex regulatory environment.

According to insights from BTIG, a global financial services firm, the average 510(k) premarket submission clearance takes approximately 162 days, nearly twice the FDA goal of 90 days. Delays in clearance are commonly caused by the need for multiple submission turnarounds when missing or additional information is required. In turn, manufacturers are experiencing vast losses of time and money.

To address these issues, RegNav has been co-developed with a specialized team of leading regulatory experts, engineers, and data scientists. The expert pool is comprised of ex-notified body regulatory professionals who have sought to ensure that the framework of RegNav is comprehensive and accurate.

Jo Wetz, CEO of Element, comments: “The end goal for RegNav is simple: to help our customers bring life-enhancing devices to market safely and more efficiently. Speaking to our existing medical device customers we realize there is a real opportunity to alleviate confusion around medical device regulation and standards, and further enhance our role as a trusted partner in their compliance and certification journey.”

Renae Leary, Chief Commercial Officer at Element, shares: “There is an incredible synergy between our new RegNav offering and existing services. Once we identify a regulatory pathway, we can also support customers in the testing and certification process, acting as a true partner for market access. RegNav strips away the complexity to give customers a clear path to compliance.”

RegNav currently supports Class I, II, and III medical devices seeking clearance/approval under FDA CFR. Element is ambitious to expand RegNav to other jurisdictions, including EU Medical Device Reporting (MDR) and In Vitro Diagnostic Regulation (IVDR). Find out more at regnav.com

Notes to Editors

Element RegNav is designed for companies both with and without existing regulatory support, offering two key services:

• RegNav Premium: Most suitable for companies with devices pre- or post-design freeze who are seeking to ensure that they are well-prepared ahead of submission. RegNav Premium provides a comprehensive and reliable compliance plan for a medical device in under two weeks. The compliance plan outlines the FDA pathway, regulations, FDA product codes, and standards that apply to a device and provides a summary of the testing requirements within each applicable standard.
• RegNav Verify: Most suitable for companies with an existing plan who want confidence that it is comprehensive before submission. RegNav Verify offers a double-checked & expert-backed review of the standards applicable to a medical device and identifies any gaps ahead of submission.

RegNav gives medical device manufacturers increased confidence that they’re testing the right thing using the right methodology.

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Fern.ai Smart Authoring: Speeding Time-to-Market for MedTech

RQM+, a leading MedTech service provider, is proud to announce the launch of the Fern.ai Smart Authoring module. The groundbreaking Fern.ai platform now includes Smart Authoring in addition to Systematic Literature Review. Together, these modules are set to transform the landscape of regulatory documentation for MedTech, enhancing compliance, accuracy, and efficiency.

As the MedTech sector evolves, regulatory demands grow increasingly complex. Fern.ai’s Smart Authoring module is designed to meet these challenges head-on, offering an intelligent solution that automates and streamlines the creation, management, readiness, and ongoing maintenance of regulatory documents.

Key Features and Benefits:

• Single Source of Truth: Smart Keys and product profiles provide a single source of truth with version control and common terminology and style
• Template Management and Alignment: Readily update content within the product profile and populate product information across templates automatically
• Dynamic Linking Across Documents: Smart Keys readily adapts to content changes and enables collaboration across authors
• Enhance Team Collaboration: Provide access to cross-functional users for in-platform comments and editing
• Streamline Literature Reviews: Conduct your literature reviews in Fern.ai and add outputs directly into your product documentation via Smart Authoring integration

Fern.ai Smart Authoring addresses the critical need of speed and accuracy for regulatory documents in preparation for submissions, helping manufacturers reduce time-to-market for their innovative products. By automating repetitive tasks and ensuring consistency across regulatory documents, the platform allows teams to focus on higher-value activities, ultimately driving greater efficiency and innovation within the organization.

“Fern.ai’s Smart Authoring module represents a significant leap forward for the medical device industry,” said John Potthoff, CEO of RQM+. “By harnessing the power of AI and automation, we’re not only simplifying the creation, management, and maintenance of regulatory documentation but more importantly, it enables manufacturers to bring life-saving devices to market faster and with greater confidence. This platform is a game-changer for regulatory affairs professionals and the MedTech industry as a whole.”

With the launch of Fern.ai’s Smart Authoring module, RQM+ reaffirms its commitment to innovation and excellence as a MedTech service provider. Based on the proven AI expertise of our instrumental development partner Giotto.ai, the Smart Authoring module paves the way for a more efficient and compliant future in MedTech.

For more information about Fern.ai Smart Authoring, visit Fern.ai.

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Under this collaboration, Trinity Biotech will provide a pool of unique multi-parameter CGM datasets from Trinity Biotech’s existing biosensor database to PulseAI. This data will be used to support the design and implementation of Trinity Biotech’s AI-driven health & wellness analytics platform. This platform will be a key component of Trinity Biotech’s CGM solution, further differentiating the affordable, needle-free and reusable diabetes management solution that Trinity plans to launch across global markets.

PulseAI are experts in evidence-based medical AI and have extensive experience in scaling AI algorithm training using medical sensor datasets. PulseAI have worked in association with Mayo Clinic to train their machine learning algorithms using large-scale datasets captured across millions of patients.

Trinity Biotech Chief Technology Officer, Dr Gary Keating, stated, “This collaboration will deliver important insights as we develop our AI driven analytical platform. This project will harness the potential of using additional personalised data from in, on and around the body to enhance the utility of continuous glucose measurements, improving the user experience, increasing satisfaction, and providing superior metabolic insights.”

PulseAI Chief Executive Officer, Alan Kennedy, stated: “We’re delighted to partner with Trinity Biotech on this project which should result in the development of powerful data analytics, and lay the groundwork for future innovation and exploration in the context of glucose monitoring and broader health analytics.”

Forward-Looking Statements

This release includes statements that constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (the “Reform Act”), including but not limited to statements related to Trinity Biotech’s cash position, financial resources and potential for future growth, market acceptance and penetration of new or planned product offerings, and future recurring revenues and results of operations. Trinity Biotech claims the protection of the safe-harbor for forward-looking statements contained in the Reform Act. These forward-looking statements are often characterised by the terms “may,” “believes,” “projects,” “expects,” “anticipates,” or words of similar import, and do not reflect historical facts. Specific forward-looking statements contained in this presentation may be affected by risks and uncertainties, including, but not limited to, our ability to capitalize on our purchase of the assets of Waveform, our continued listing on the Nasdaq Stock Market, our ability to achieve profitable operations in the future, the impact of the spread of COVID-19 and its variants, potential excess inventory levels and inventory imbalances at the company’s distributors, losses or system failures with respect to Trinity Biotech’s facilities or manufacturing operations, the effect of exchange rate fluctuations on international operations, fluctuations in quarterly operating results, dependence on suppliers, the market acceptance of Trinity Biotech’s products and services, the continuing development of its products, required government approvals, risks associated with manufacturing and distributing its products on a commercial scale free of defects, risks related to the introduction of new instruments manufactured by third parties, risks associated with competing in the human diagnostic market, risks related to the protection of Trinity Biotech’s intellectual property or claims of infringement of intellectual property asserted by third parties and risks related to condition of the United States economy and other risks detailed under “Risk Factors” in Trinity Biotech’s annual report on Form 20-F for the fiscal year ended December 31, 2023 and Trinity Biotech’s other periodic reports filed from time to time with the United States Securities and Exchange Commission. Forward-looking statements speak only as of the date the statements were made. Trinity Biotech does not undertake and specifically disclaims any obligation to update any forward-looking statements.

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inHEART, a medical device company delivering the world’s most advanced, AI-driven digital twin of the heart, has raised $11M to drive commercial growth of its therapeutic software solution for cardiac ablation procedures and advance the development of its predictive cardiac models for heart failure, sudden cardiac death, and cardio-embolic stroke.

The financing was led by Vesalius Biocapital IV and co-led by Elaia Partners with participation from NACO, Sagana, Sofia Angel Ventures, CWR Funds, and Webit Investment Network. In addition, inHEART received funds from a successful crowdequity campaign on Tudigo and from the UK impact fund Astorg Foundation.

“We welcome this strong international group of investors to our latest round of financing,” said Todor Jeliaskov, Chairman and CEO of inHEART. “This new round allows us to go further in addressing the needs of cardiac patients from early screening and disease detection through advanced therapeutic support. It’s exciting for us to be at the forefront of transforming the healthcare industry with the power of AI technology by improving the efficiency of care, quality of decision-making, and effectiveness and safety of medical interventions.” 

“We are enthusiastic to continue our support and co-lead this financing round for inHEART,” said Samantha Jérusalmy, board member at inHEART and Partner at Elaia. “inHEART’s AI-driven 3D cardiac mapping enables unprecedented precision in targeting and treating arrhythmias, setting new standards in the treatment of heart conditions.”

“At Vesalius Biocapital IV, we’re dedicated to supporting advancements in medical technology that improve patient care.” said Jean-Christophe Renondin, Managing Partner at Vesalius Biocapital IV. “inHEART’s AI-driven solutions exemplify the future of cardiac care, offering personalized therapy options and predictive models that can enhance clinical outcomes and streamline treatment processes. We’re excited to contribute to inHEART’s journey as they revolutionize cardiac care and address global healthcare needs with cutting-edge technology and innovation.”

Optimizing cardiac care

inHEART’s current therapeutic solution addresses the challenges of conventional cardiac ablations. The inHEART solution creates highly detailed, interactive 3D heart models with proprietary AI-driven cardiac CT or MR image segmentation. These 3D models of the heart allow physicians to optimize treatment strategies based on each patient’s unique cardiac anatomy and to support pre-procedural planning for faster ablation procedures and improved clinical outcomes.

AI-driven predictive models

Financing from this round will also support the development of new product verticals for AI-driven predictive software models for sudden cardiac death and cardio-embolic stroke, as well as a new therapeutic software solution to help physicians treat heart failure patients. Currently, inHEART is commercially available in the US and EU through a direct sales force model, with plans to establish a global distribution network in the coming months to further accelerate growth.

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