Episode Details

FDA drafts rules for surgical robots; OpenEvidence valued at $15 billion; coding AI lifts Hartford primary care revenue 17%; infant insulin tool wins breakthrough status

The voices on this episode are generated, and so is the script, from the day's post at Physician in the Loop. Every fact in the post links to its source.

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The Food and Drug Administration on Friday published draft guidance setting out what makers of robotically assisted surgical systems must submit before sale, including latency testing, surgeon training and risk reviews of any AI features.

The draft leaves out remotely teleoperated systems and autonomous robots that perform significant parts of an operation. About 5,000 telesurgeries have been performed worldwide, urologist Dr. Vipul Patel estimated in a Healthcare Dive report Wednesday, which also noted FDA breakthrough designation this month for XCath's Iris remote stroke thrombectomy robot and an FDA authorization in July for Johnson & Johnson's Ottava system.

OpenEvidence, which makes a clinical search tool for physicians, raised $250 million at a $15 billion valuation, according to reports this week. Hartford HealthCare said autonomous coding raised its primary care revenue 17% while patient complaints rose and a neurology pilot was halted. The FDA also named insulin dosing software for hospitalized newborns a breakthrough device, and a CT model predicted organ failure in acute pancreatitis hours before it was clinically evident.

In this episode

• FDA drafts premarket rules for surgical robots that exclude remote telesurgery and autonomous systems; comments due Nov. 24
• OpenEvidence raises $250 million at $15 billion valuation, up from $12 billion in January, as it plans its own cancer drugs
• Hartford HealthCare says autonomous coding raised primary care revenue 17%; patient complaints rose and a neurology pilot was halted
• FDA grants breakthrough designation to insulin dosing software for hospitalized newborns and infants under 2
• CT deep learning model predicts organ failure in acute pancreatitis a median 3.5 hours early in 2,746-patient retrospective study
• UChicago Medicine automates routine prior authorization and insurance checks and moves staff to complex cases with no job cuts