Podcast: KHN’s ‘What The Health?’ Health Nerd Books For The Holidays
From Kaiser Health News Network – Their latest podcast, What the Health, episode 73, This week, The Food and Drug Administration took some serious steps…
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HITECH and the FDA’s Overhaul of Medical Device Approvals
By Kayla Matthews – Since 1976, the U.S. Food and Drug Administration (FDA) has offered a fast-track approval process for medical device manufacturers that could prove their products were substantially similar to approved items that were already in the marketplace.
Podcast: KHN’s ‘What The Health?’ A Detour On A Smoking Off-Ramp
From Kaiser Health News Network – Their latest podcast, What the Health, episode 63, This week, The Food and Drug Administration declared that vaping among…
FDA Acts on Radiological CDS
By William A. Hyman – The FDA took two recent actions in the domain of CDS for radiological image interpretation. One was to permit the marketing under the De Novo program of software for the interpretation of fractures of the wrist.
FDA Asks for Input on Software That Isn’t a Medical Device
By William A. Hyman – It has long been clear that the FDA can regulate software that falls under the definition of a medical device. Such software might be part of and integral to a more physical chunk of technology.
FDA and Digital Health Regulation
By David Harlow – The FDA had a digital health banner day on December 7, announcing one final guidance and two draft guidance documents (with a 60-day comment period). Collectively, these guidances cover a range of digital health issues.
CDS, PDS and FDA
By William Hyman – The 21st Century Cures Act addressed what kinds of medical software are medical devices (and therefore subject to regulation by the FDA), and what kinds are not medical devices (and therefore not regulated by the FDA, but subject to CPSC and FTC).
FDA Approves, CMS Proposes Coverage of First Test to Detect Extensive Number of Cancer Biomarkers
The U.S. Food and Drug Administration approved the FoundationOne CDx, the first breakthrough-designated, next generation sequencing (NGS)-based in vitro diagnostic test that can detect genetic…
The Great Digital Hope or Just Hype
By Matt Fisher – Healthcare has become the proverbial shiny object to many technology companies, both within and without of Silicon Valley. The technology companies seem to view healthcare as a great, untapped wilderness that is flush with potential profits.