Pulse check: An analysis of the FDA’s list of AI- and ML-enabled devices
A look at the FDA’s new database of AI and ML-enabled devices, and an exploration of what can be gleaned from the data.
Podcast: The current state of digital health regulation
In 2017, the FDA launched its Digital Health Pre-Certification Program, also known as Pre-Cert, to work with innovators to develop a new approach to regulatory oversight for software-based medical technologies. Nearly two years into the pilot program, we wanted to get a status update and hear what’s in store for the program this year and beyond.
How should the FDA approach the regulation of AI and machine learning in healthcare?
Rock Health and Evidation convened experts to explore key questions—and we want to know what you think.
FDA compliance made easy: Welcome, Enzyme!
Even small med device, drug, or digital health companies can shell out hundreds of thousands of dollars annually in consulting fees on labor-intensive, slow, paper-based processes—with larger companies spending millions. These companies are tackling some of healthcare’s biggest problems, and we believe regulatory compliance workflow shouldn’t be an expensive bottleneck. That’s why we’re thrilled to announce our latest investment in Enzyme, a company building software to help large and small enterprises alike streamline workflow, making regulatory compliance a seamless part of the development process.
What you need to know about FDA’s game-changing Digital Health Innovation Action Plan
We noted in our midyear funding report that we’d be keeping a close eye on the FDA’s plan to set more definitive regulatory guidelines for digital health in the coming months. It turns out we didn’t have to wait too long—on July 27th, the FDA announced the Digital Health Innovation Action Plan, which includes the launch of the much-talked about Software Precertification Pilot Program (PreCert).
We can land spaceships on comets. Why can’t we design prosthetics for Veterans?
Andrea Ippolito, Presidential Innovation Fellow at Veterans Affairs
Army Veteran Lisa Marie Wiley is faced with ...
Rock Weekly: #YouOnlyLiveOnesie
Choosing the right surgeon can be a matter of life or death, but how reliable is this Surgeon Score Card database that took the Interwebs by storm? Some sing its praises while others cry methodological foul.
Rock Weekly: Wearables: we’re doing it wrong.
June 29, 2015
SCOTUS stole the show last week with two huge rulings affecting healthcare's future. King v. ...
Deconstructing the Fitbit IPO and S-1
Fitbit is the latest iconic digital health company planning to IPO, with a drastically different operating history ...
Money pours into health insurance startups
April 13, 2015
What do patient data, EHRs, and health insurance as we know it have in common? They’re all in ...
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