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FDA| Healthcare FDA Regulation | Policy, News, Analysis, Insights - HIT Consultant

AdvaMed Launches Center for Digital Health to Advance Data-Driven Healthcare

by Fred Pennic 10/15/2019 Leave a Comment

AdvaMed Launches Center for Digital Health to Advance Data-Driven Healthcare

- AdvaMed launches Center for Digital Health, an advocacy platform to drive data-driven healthcare- The Center for Digital Health includes a wide range of medical and digital technology companies that are leveraging health care data and technology innovation to enable new insights, support health and wellness, improve patient interventions and outcomes and enhance the quality and efficiency of healthcare delivery.The Advanced Medical Technology Association (AdvaMed) today announced the launch of
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BioElectronics Founder and CEO Andrew J. Whelan Passes Away

by Fred Pennic 10/09/2019 Leave a Comment

BioElectronics Founder and CEO Andrew J. Whelan Passes Away

- BioElectronics founder and CEO Andrew J. Whelan has died suddenly on Monday night. - The BioElectronics management team will continue to manage day-to-day operations until a permanent replacement can be confirmed. Andrew J. Whelan, founder, and CEO of BioElectronics Corp. suddenly passed away in his home Monday night in Frederick, Maryland.  Mr. Whelan founded BioElectronics Corporation to bring to market a breakthrough drug-free medical device, ActiPatch Therapy. ActiPatch is an
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ECRI Institute: Top 10 Health Technology Hazards to Watch in 2020

by Jasmine Pennic 10/08/2019 Leave a Comment

ECRI Institute: Top 10 Health Technology Hazards to Watch in 2020

- Surgical stapler misuse and point-of-care ultrasound tops ECRI Institute’s 2020 health technology hazards list that warrant attention from healthcare leaders. - Hazards selected are based on a rigorous review of ECRI’s incident investigations, medical device testing, and public and private incident reporting databases.ECRI Institute identified surgical stapler misuse as the number one health technology hazard in its Top 10 Health Technology Hazards for 2020 report. ECRI Institute’s Top 10
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Why Tele-Treatment Will Be The Next Evolution of Telehealth

by Mark Toland, President and CEO, Corindus Vascular Robotics 10/01/2019 Leave a Comment

Tele-Treatment: How We Close the Gap in Access to Care

Ubiquitous mobile technology like cell phones and smart watches play an increasingly important role in our health. You can have a checkup with your physician via the camera on your phone. If your heart rate becomes irregular, your Apple Watch will let you know (proven accuracy notwithstanding). Just the thought of using a wristwatch to monitor your health would have elicited mocking laughter in the not-too-distant past. Telehealth and wearables have made amazing strides in a short period and
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Eko Raises $20M to Expand Machine Learning Platform for Cardiac Monitoring/Analysis

by Jasmine Pennic 09/25/2019 Leave a Comment

AI-Powered Digital Health Company Eko Closes $20 Million Series B to Continue the Fight Against Heart Disease

- AI-driven digital health startup Eko raises $20M led by ARTIS Ventures with participation from 3M and Mayo Clinic. - Funding will be used to accelerate research and development (R&D) and commercialization of Eko’s machine learning platform for cardiac screening/analysis. - Eko’s cardiac monitor combines digital stethoscope and ECG technology both for in-clinic and at-home monitoring, which enables patients to seamlessly and consistently send cardiac data to their
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Backed by Optum Ventures, Kaia Health Raises $8M for AI-Driven Digital Therapeutics for Back Pain & COPD

by Fred Pennic 09/17/2019 Leave a Comment

Backed by Optum Ventures, Kaia Health Raises $8M for AI-Driven Digital Therapeutics for Back Pain & COPD

- Digital therapeutics startup Kaia Health raises $8M in funding led by Optum Ventures to support the accelerated execution of clinical trials required to demonstrate efficacy to the FDA.- Kaia Health utilizes multimodal therapy, which combines physical, psychological and educational elements to relieve back pain at home, without medication.- Optum’s investment in Kaia Health will consider use of Kaia Health’s digital therapeutic offerings for back pain and COPD with Optum and UnitedHealth
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FDA Clears GE Healthcare’s AI Algorithms Embedded on Mobile X-Ray Device

by Fred Pennic 09/13/2019 Leave a Comment

GE Healthcare Receives FDA Clearance of First Artificial Intelligence Algorithms Embedded On-Device to Prioritize Critical Chest X-ray Review

- GE Healthcare awarded Food and Drug Administration’s 510(k) clearance of Critical Care Suite, an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. - Algorithms help radiologists prioritize critical cases with a suspected pneumothorax – a type of collapsed lung – by immediately flagging critical cases to radiologists for triage, which could drastically cut the average review time from up to eight hours. - Critical Care Suite offers
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Healthy.io Nabs $60M for FDA-cleared Smartphone-Based Urinalysis for Chronic Kidney Disease

by Jasmine Pennic 09/12/2019 Leave a Comment

Healthy.io Nabs $60M for FDA-cleared Smartphone-Based Urinalysis for Chronic Kidney Disease

- Healthy.io raises $60M led by Corner Ventures for its FDA 510(k) cleared smartphone-based ACR test to be used in the aid of diagnosing chronic kidney disease (CKD). - The funding round will be used to accelerate Healthy.io’s global expansion and product development. - Healthy.io’s solution allows immediate electronic medical record (EMR) connectivity through the automated smartphone scan.  Healthy.io, the fast-growing Israeli digital health company that has turned the
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Cognoa, EVERSANA Partner to Advance the Commercialization Standard for Prescription Digital Medicines

by Jasmine Pennic 09/11/2019 Leave a Comment

Cognoa, EVERSANA Partner to Advance the Commercialization Standard for Prescription Digital Medicines

- Cognoa and EVERSANA form a partnership that will enable prescription, dispensation, and reimbursement of Cognoa’s behavioral health products. - Cognoa is developing digital medicine solutions to change the standard of care in pediatric behavioral health to improve the lifelong outcomes for children. - Cognoa selected EVERSANA, a fully integrated and independent commercial services platform, to develop and manage a go-to-market strategy that ensures comprehensive market
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Life Image Launches Real World Imaging for RWE Programs

by Jasmine Pennic 09/05/2019 Leave a Comment

Life Image Launches Real World Imaging for RWE Programs

- Life Image launches Real World Imaging (RWI) offering to respond to researcher needs for maturing insights and accelerating drug development decisions.  - Imaging data, especially for Real World Evidence (RWE), has historically been difficult, if not impossible, to access, retrieve, view, de-identify and normalize at-scale, even though it provides clinically material insights for a growing number of therapies. - Life Image represents the only company providing large, heterogeneous,
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