RenalytixAI, a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, today announced that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX™. This is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company.FDA Breakthrough Devices Program OverviewThe FDA’s Breakthrough Devices Program is a voluntary program for certain
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Misonix Acquires Regenerative Wound Healing Product Theraskin for $97M
Misonix, Inc., a provider
of minimally invasive therapeutic ultrasonic medical devices announced it has
entered into a definitive agreement to acquire
Solsys Medical, LLC, a privately
held regenerative medical company in an all-stock transaction valued at
approximately $97 million. The acquisition of Solsys substantially broadens
Misonix’s addressable market through wound care solutions that are complementary
to its existing products.
Theraskin:
Real Skin from One Human to
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Validic Integrates With Welldoc’s Bluestar Platform to Enable Real-Time Insights for Patients
Validic, a provider of data solutions for remote monitoring and virtual engagement is integrating with Welldoc’s BlueStar platform. The integration of personal health data within the Welldoc BlueStar digital therapeutic platform will allow users to connect their wearables, apps, and in-home health devices directly to the platform – enabling deeper engagement and better self-management of one's health.The Power of Leveraging Device-Generated Data for PatientsAs the number of people managing
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Massachusetts Launches Digital Health ‘Sandbox’ Program for Startups
On Wednesday, Massachusetts Governor Charlie Baker joined members of the Massachusetts Digital Health Council to announce a new program to drive the growth of innovative startups in the state, helping them access unique R&D facilities in the state. The announcement was made at Worcester Polytechnic Institute’s PracticePoint research, development and commercialization alliance, the first R&D ‘sandbox’ selected to host startups as part of the program. That facility was the recipient of a
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Security Vulnerabilities Detected in ICDs: Addressing Ransomware Risk in Medical Devices
Medical device usage is on the rise, and that reality potentially puts people at risk if those gadgets have security flaws. It's crucial for device manufacturers, industry regulators and health practitioners to work together to ensure safety are paramount as adoption rises.Internal health devices are particularly at risk, especially since patients and providers may not immediately notice issues. The people who use or prescribe them assume they'll work as expected and typically don't have ways to
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What The Failure of Microsoft’s HealthVault Means for the Future of EHRs
Microsoft recently announced that it is officially shutting down HealthVault at the end of this year. HealthVault was Microsoft’s attempt at a web-based personal health record system. You probably never used it -- it suffered low adoption. But while HealthVault will shut down, mobile apps that collect and store your personal health information and share it with your healthcare team are poised to revolutionize medicine and wellness practice.
The downfalls of HealthVault included its focus on
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PathAI Lands $60M to Accelerate AI-Powered Pathology Platform
PathAI, a Boston, MA-based provider of AI-powered pathology platform has raised $60M in Series B funding led by General Atlantic with strong participation from General Catalyst and other existing investors. General Atlantic Managing Director Dr. Michelle Dipp will be joining PathAI’s board of directors.Advanced Learning Towards Faster More Accurate Diagnosis of DiseaseCo-founded by Chief Executive Officer Dr. Andy Beck in 2016 with the mission to offer faster, safer and more powerful solutions
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10 Major Barriers Hindering The Digitalization Of Chronic Conditions
Hundreds of millions of patients are affected by chronic diseases globally, often suffering from several of them. Despite such a huge opportunity, the coverage of chronic conditions with digital solutions is still below the acceptable level. Today, more than twenty common chronic conditions have its own specificity and are currently at its digital development stage, yet all of them face the same challenges in the digital health market, according to a recent Research2Guidance report.The report,
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Medidata Launches New Life Sciences Company, Acorn AI
Life sciences digital transformation company Medidata, today announced the launch of Acorn AI, a new company designed to provide actionable insights across the entire drug continuum – from R&D to commercialization. In addition, the company has appointed Rama Kondru, Ph.D., as the chief information officer for Medidata and Acorn AI’s first CIO to lead the company’s enterprise data strategy, architecture and future platform development – all helping the company to accelerate the creation of
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The Cost of Medical Device Innovation: Can The U.S. Keep Pace?
Over the last six years, the U.S. Food and Drug Administration has approved a number of highly innovative medical devices that have revolutionized cardiovascular care. These novel devices have provided advanced treatment options, improved quality of life and extended longevity for patients. Unfortunately, reimbursement has often failed to keep up with many of increasingly expensive treatment options, according to a new report released by Vizient. The report, The cost of medical device
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