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 SHORT READ
The Food and Drug Administration on Friday published draft guidance setting out what makers of robotically assisted surgical systems must submit before sale, including latency testing, surgeon training and risk reviews of any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.
THE DETAILS
- Regulation Sept 25, 2026The FDA published draft guidance Friday on what makers of robotically assisted surgical devices should submit before marketing, covering bench, cadaver and clinical testing, labeling, and validated training for surgeons, bedside assistants and scrub nurses. The draft asks manufacturers to measure the total delay from the surgeon's hand at the console to instrument motion under worst-case loads and to assess the risk of AI features such as image segmentation and critical structure identification. It proposes an "umbrella and covered procedure" approach that would let data from complex procedures support authorization for less complex ones in the same specialty. Remotely teleoperated systems and autonomous robots that perform significant aspects of an operation independent of the surgeon are outside its scope, according to the document. Comments are due Nov. 24 under docket FDA-2026-N-9505.
- Money Sept 25, 2026OpenEvidence raised $250 million at a $15 billion valuation in a round with Andreessen Horowitz and hospital systems, Axios reported Friday, citing Business Insider. The company was valued at $12 billion in January, according to Refresh Miami. Chief Executive Daniel Nadler told Forbes this month that the company plans to use data from Memorial Sloan Kettering and the National Comprehensive Cancer Network to develop its own pipeline of therapies, with a first drug in clinical trials before year-end and three to five more candidates next year.
- Deployment Sept 25, 2026Hartford HealthCare, a 10-hospital system in Connecticut, said pairing autonomous coding with ambient documentation raised primary care revenue 17% in a pilot that began in September 2025, according to Becker's Hospital Review. Kalan Blair, senior director of revenue cycle, said patient and provider complaints increased as patient-responsibility charges rose, especially after deductibles reset Jan. 1, and physicians were not always aware the platform was adding charges. The system stopped a pilot with eight neurologists as a poor fit for the specialty's complexity and reported positive results in endocrinology and medical weight loss, Blair said. The Blue Cross Blue Shield Association said this week that hospital AI coding added $942 million to its plans' costs from 2023 to 2025 with no matching change in care.Sources: Becker's Hospital Review, Fierce Healthcare
- Regulation Sept 24, 2026The FDA granted breakthrough device designation to Glucommander Pediatrics, Glytec's insulin dosing recommendation software for neonates and infants from birth to under 2 years old who need continuous intravenous insulin, the company said Thursday. No FDA-cleared insulin dosing software exists for that age group, according to Glytec. Target conditions include diabetic ketoacidosis, hyperglycemic hyperosmolar state, hyperglycemia of prematurity and persistent hyperglycemia in critically ill infants. The prescription-only product has not been cleared. Glytec said its existing software serves more than 400 hospitals and health systems and has covered patients ages 2 to 17 since 2012.
- Evidence Sept 24, 2026A model that combines deep learning features from multiphase CT with clinical variables predicted organ failure in acute pancreatitis with an area under the curve of 0.89 in validation and 0.81 in an external test set, compared with 0.68 to 0.74 for the modified CT Severity Index and 0.67 to 0.71 for clinical models, researchers reported in the Journal of Pancreatology. The study covered 2,746 patients treated from 2011 to 2024. The model's negative predictive value was 97.2%, and it flagged 55% of cases at least three hours before organ failure was clinically evident, with a median lead of 3.5 hours, according to Radiology Business. The analysis was retrospective.Sources: Journal of Pancreatology, Radiology Business
- Workforce Sept 25, 2026UChicago Medicine automated insurance verification, prior authorization and imaging clearances through an Epic-integrated vendor workflow and now clears 95% of certain cases up to 28 days before service, about 12 days earlier than before, according to Becker's Hospital Review. Matthew Kennedy, director of patient access and financial clearance, said there was no headcount reduction and staff moved to complex surgeries, labor plans, payer follow-up and unclear authorization requirements. "AI is not a 'set it and forget it' thing. AI is going to make mistakes," Kennedy said.Source: Becker's Hospital Review