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.
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).
Rock Weekly: The FDA approval you’ve been waiting for
February 23, 2015
Last week the FDA gave our friends at 23andMe a big green light to market genetic testing for ...
Rock Weekly: These 58 companies have a message for the FDA
October 13, 2014
Last week, 58 companies spanning tech and health pushed Congress to finally codify some ...
Rock Weekly: “The FDA is no longer the primary authority on innovation”
San Francisco was rattled last week, and not just by the earthquake. At our packed Health Innovation Summit, ...
Rock Weekly: 23andMe makes up with the FDA
June 23, 2014
The FDA is up to their neck in digital health. First, in a rare move, they announced they’ll ...
Rock Weekly: The FDA Digital Health Showdown Begins
March 3, 2014
The showdown over mobile medical app regulation heated up last week as Congress introduced a bill to ...
Rock Weekly: This is why Google met with the FDA
January 20, 2014
Last week, amid the JP Morgan Healthcare conference/invasion in San Francisco, we welcomed the ...
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