Physician in the Loop

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

Show Notes

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.

Read the post and its sources

The Food and Drug Administration on Friday published draft guidance setting out what makers of robotically assisted surgical systems must submit before sale, including latency testing, surgeon training and risk reviews of any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

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How technological innovation is changing medicine for patients and the people who practice on the front lines.

Nora: This is Physician in the Loop, the daily briefing on AI in medicine. I'm Nora Davis.

James: And I'm James Hudson. It's Saturday, September 26th, 2026.

Nora: The FDA's new draft guidance for surgical robots covers a lot of ground, but two categories are missing entirely.

James: Let me guess. The parts moving fastest.

Nora: Exactly. Remote telesurgery and autonomous robots that do significant parts of an operation on their own. Both left out of scope.

James: So the rulebook covers the robots we already know, not the ones showing up next.

Nora: Today I've got the FDA's surgical robot guidance, and Hartford HealthCare's coding pilot.

James: And I've got OpenEvidence's new valuation, plus a breakthrough designation for newborn insulin dosing software.

Nora: So, the FDA published this draft guidance Friday. It's about what makers of robotically assisted surgical systems have to submit before they can sell them.

James: What are they actually asking for?

Nora: Bench, cadaver and clinical testing. Validated training for surgeons, bedside assistants, scrub nurses. And they want manufacturers to measure the full delay from the surgeon's hand at the console to the instrument actually moving, under worst-case loads.

James: And AI features specifically?

Nora: Risk reviews for things like image segmentation and critical structure identification. There's also an umbrella approach, where data from complex procedures could support authorization for simpler ones in the same specialty.

James: But none of it touches telesurgery or autonomous systems, which is where Healthcare Dive comes in.

Nora: Right. Healthcare Dive reported Wednesday that urologist Dr. Vipul Patel estimates about 5,000 telesurgeries have been performed worldwide. That same report noted FDA breakthrough designation this month for XCath's Iris remote stroke thrombectomy robot, and an FDA authorization in July for Johnson and Johnson's Ottava system.

James: Comments on the draft are due when?

Nora: November 24, under the docket. So there's time for people to weigh in on what's covered, and what isn't.

James: Alright, my turn. OpenEvidence just raised $250 million at a $15 billion valuation, according to reports this week.

Nora: That's a jump from where they were in January.

James: Refresh Miami had them at $12 billion in January. Axios reported the new round Friday, citing Business Insider, with Andreessen Horowitz and hospital systems in it.

Nora: OpenEvidence makes a clinical search tool for physicians. What's the money for?

James: Chief Executive Daniel Nadler told Forbes this month the company wants to build its own pipeline of cancer drugs, using data from Memorial Sloan Kettering and the National Comprehensive Cancer Network.

Nora: A search tool company developing therapies is a stretch from where they started.

James: Nadler's timeline has a first drug in clinical trials before year-end, and three to five more candidates next year.

Nora: Now to Hartford HealthCare. Becker's Hospital Review reported the ten-hospital system paired autonomous coding with ambient documentation, and primary care revenue rose 17% in a pilot that started last September.

James: That's a strong number. What's the catch?

Nora: Kalan Blair, senior director of revenue cycle, said patient and provider complaints rose along with it. Patient-responsibility charges climbed, especially after deductibles reset January 1, and physicians weren't always aware the platform was adding charges.

James: Did it work everywhere?

Nora: No. They halted a pilot with eight neurologists, calling it a poor fit for the specialty's complexity. Endocrinology and medical weight loss did well, Blair said.

James: And this week the Blue Cross Blue Shield Association said hospital AI coding tools added $942 million to its plans' costs from 2023 through 2025, with no matching change in care.

Nora: So the revenue gain on one side and that cost number on the other are an awkward pair to hold at once.

James: Last one from me is lighter. The FDA gave breakthrough device designation to Glucommander Pediatrics, Glytec's insulin dosing software for hospitalized infants under 2 who need continuous intravenous insulin.

Nora: Is there anything cleared for that age group already?

James: Glytec says no FDA-cleared insulin dosing software exists for infants that young. This one is meant for conditions like diabetic ketoacidosis and persistent hyperglycemia in critically ill infants.

Nora: It's prescription-only, and not cleared yet, just designated.

James: Right. Glytec says its existing software already runs in more than 400 hospitals and has covered patients ages 2 to 17 since 2012.

Nora: Before we go, two things to watch.

James: First, payer AI denials. The Blue Cross Blue Shield Association's $942 million figure we mentioned earlier isn't going away quietly.

Nora: CMS Administrator Dr. Mehmet Oz said AI will be “inflationary” in the short term, and health system leaders are calling the payer-provider fight “bot wars,” according to Becker's.

James: Connecticut bars AI-only denials on state plans starting January 1, 2027. California's AB 1979 and AB 2575 are waiting on the governor by September 30.

Nora: Second, agent-mediated tools reaching the wards. Mass General Brigham says it is not allowing autonomous AI across different platforms.

James: And a kill switch is now a design requirement at Parkview and Brigham, according to Becker's.

Nora: What's the line they're watching for?

James: The same one as before: an agent placing an order in a US hospital without a signature. Nobody's crossed it yet, but the guardrails are going up ahead of it.

Nora: Sources and corrections are at physicianintheloop.org. I'm Nora Davis.

James: I'm James Hudson. See you tomorrow.