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Medical Devices | FDA | News, Analysis, Insights - HIT Consultant

Why COVID-19 is Prompting Device OEMs to Partner with Software Developers

by Mike Juran, CEO and co-founder of Altia 05/26/2020 Leave a Comment

Why COVID-19 is Prompting Device OEMs to Partner with Software Developers

As COVID-19 continues to sicken thousands across the U.S., hospital staffs deserve every bit of praise they’re receiving for their service. Yet there’s another segment of the medical community on the front lines of the pandemic: medical device manufacturers. While some forms of medical equipment have been marginalized or sidelined altogether, manufacturers of essential devices are working around the clock. According to an April 2020 Fortune Business Insights report, those with significant
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2020 MedTech Breakthrough Award Winners Announced

by Fred Pennic 05/21/2020 Leave a Comment

2020 MedTech Breakthrough Award Winners Announced

What You Should Know: - MedTech Breakthrough announces 2020 MedTech Breakthrough Award Winners that recognizes the top companies, people, platforms, and products in the health, fitness, and medical technology industries today. - The 2020 MedTech Breakthrough Awards program is open to all individuals, companies, and organizations involved in producing digital health and medical technology products and services.  MedTech Breakthrough, a market intelligence organization that recognizes
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FDA Grants Eko Emergency Use Authorization for Low Ejection Fraction AI

by Fred Pennic 05/13/2020 Leave a Comment

FDA Grants Eko Emergency Use Authorization for Low Ejection Fraction AI

What You Should Know: - The FDA granted Emergency Use Authorization to Eko for an ECG-based algorithm that screens for low ejection fraction, as part of an assessment of cardiac complications and co-morbidities associated with COVID-19. - This ECG-based deep learning algorithm, developed on a large clinical dataset in collaboration with the Mayo Clinic, can help efficiently identify signs of possible heart failure in patients. Eko, a digital health company building
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The DNA Company Acquires AI Digital Therapeutics App for $30M to Form My Next Health

by Fred Pennic 05/13/2020 Leave a Comment

The DNA Company Acquires AI Digital Therapeutics App for $30M to Form My Next Health

What You Should Know: - DNA Company acquires AI-based digital therapeutics app My Pain Sensei (MPS) to form My Next Health and is building a COVID-19 risk assessment platform to help people understand their risks of developing serious COVID-19 complications.  - The acquisition combines functional genomics with conversational AI for patient self-management apps and disease tracking tools designed to inform clinician-patient interactions. Leading functional genomics provider The
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3 Major Challenges Plaguing Europe’s Digital Healthcare Efforts

by Jasmine Pennic 05/12/2020 Leave a Comment

3 Challenges Plaguing Europe’s Digital Healthcare Efforts

As the concept of digital healthcare goes global, healthcare stakeholders across geographies are evaluating new tools, while innovators are navigating pathways to implement advanced technologies into healthcare. Over the past decade, the European healthcare system has progressed leaps and bounds. However, the sector is bound by some major challenges including the aging population, greater prevalence of chronic diseases, shortage of healthcare workers, and financial discrepancies of care. In
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New Coin-Size Disposable Wearable Medical Device Enables COVID-19 Symptom Monitoring

by Fred Pennic 05/08/2020 Leave a Comment

New Coin-Size Disposable Wearable Medical Device Enables COVID-19 Symptom Monitoring

What You Should Know: - As the government guides state re-openings, digital health startup BioIntelliSense announced the newest advancements of its medical-grade biosensor solution portfolio and Data-as-a-Service (DaaS) platform. - The company’s new COVID-19 Return to Work and School solution generates a more reliable clinical assessment of an individual’s infectious risk status through home-based screening tools and data-driven clearance
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Healthcare Data Platform H1 Raises $12.9M to Fuel Growth

by Jasmine Pennic 04/22/2020 Leave a Comment

Healthcare Data Platform H1 Raises $12.9M to Fuel Growth

What You Should Know:  - H1, the biggest database in the world connecting healthcare, life science professionals, and companies raises $12.9M in funding. - Its healthcare data platform provides comprehensive in-depth profiles of more than 8 million healthcare professionals and 16,000 institutions in 70+ countries, all of which are kept up-to-date weekly. The platform enables users to understand and analyze any healthcare professional’s full profile, including expertise, interests,
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COVID-19: National Medical Device Registry Launches to Track Ventilators for Hospitals

by Fred Pennic 04/17/2020 Leave a Comment

National Medical Device Registry to Track Ventilators for Hospitals

What You Should Know: Free registry enables any hospital to log and track ventilators with a simple scan to help with the COVID-19 crisis. The LocatorX National Medical Device Registry will be accessible by facility managers and appropriate governmental agencies who require visibility into ventilator availability at no charge during this crisis.  LocatorX, which provides accurate, inexpensive, and flexible tracking technology to companies across a variety of industries, today
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OnScale Launches ‘Digital Twins’ of Lungs to Improve COVID-19 Patients Outcomes

by Fred Pennic 04/15/2020 Leave a Comment

OnScale Launches ‘Digital Twins’ of Lungs to Improve COVID-19 Patients Outcomes

What You Should Know: - OnScale announced the kickoff of the Project BreatheEasy by leveraging massively scalable cloud bioengineering simulation and AI to create “Digital Twins” of the lungs of COVID-19 patients. - The goal of the project is to optimize the utilization of limited ventilator and respiratory equipment and improve patient outcomes. - OnScale is currently testing the solution with medical experts and is actively seeking additional partners and advisors. OnScale, a
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COVID-19: 5 Steps for Health IT Teams to Accommodate New Demands

by Bob Zemke, CISSP CPHIMS, and Doug McDonald, FHIMSS CPHIMS at Extreme Networks 03/26/2020 Leave a Comment

5 Steps for Health IT Teams During COVID-19

The rapid escalation of COVID-19 patient cases has created new challenges for healthcare organizations to scale up testing and care services, while also reducing risk for non-critical patients or care workers. Healthcare IT professionals are being asked to digitally transform overnight, in supporting remote workers, telemedicine, outdoor triage tents, and a surge in patients and connected devices. Here are five key steps for healthcare IT departments to take in order to accommodate the new
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