Revisited: FDA's AI Medical Device Approvals

About a year ago, I dug into FDA’s newly-released list of its AI medical device approvals. In that post, I noted some surprising findings: AI approvals were (1) becoming more concentrated, with a small group of companies winning a large percentage of the approvals, and (2) most approvals were going to established medical device titans, like Siemens and GE, rather than to startups. Both findings showing that AI in medicine was providing sustaining innovation for established companies more than disrupting the established ecosystem. With this release, I wanted to see if my earlier findings still held, how fast innovation was accelerating, how quickly were more companies getting involved — and what other surprises lay within the data.

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Disruption for Doctors 3: the Rise of Selfcare

Four decades of increasingly consumer-focused IT developments have given consumers more and more ability to care for their own health, pulling activities out of the healthcare system. Healthcare, for the most part, is unaware of the process, or dismissive of “Dr. Google”. But this “selfcare” revolution will continue to empower consumers — and to disrupt healthcare.

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