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BTIG analysts wrote that installations of Intuitive’s new robotic surgery system are “well ahead of lofty” expectations.

Vertex AI Search for Healthcare is designed to quickly query a patient’s medical record. Google says the tool will reduce the administrative burden for payers and providers.

The financially struggling healthcare and pharmacy giant also pulled its earnings guidance, citing increased medical cost pressures in its health benefits unit.

Former CDRH leader Jeff Shuren told an audience at The Medtech Conference that Michelle Tarver “will make an excellent center director, and quite frankly, the best is yet to come.”

The move is a blow to Gilead’s cancer portfolio. Trodelvy, an antibody-drug conjugate granted accelerated approval for bladder cancer in 2021, failed its confirmatory trial earlier this year.

This week marked the start of the third-quarter earnings season, with Johnson & Johnson exceeding Wall Street’s expectations. Pfizer is projected to have a strong quarter, while Eli Lilly could pull ahead of Novo Nordisk in the obesity space. Moderna, by contrast, has a decidedly negative outlook.

The Coalition for Health AI is seeking feedback on the proposals, which detail how the group will certify labs and a “nutrition label” that aims to give buyers more information about AI models.

The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.

Merck’s investigational antibody clesrovimab demonstrated more than 60% effectiveness in reducing some types of respiratory syncytial virus-associated infections in infants, while Pfizer’s RSV vaccine Abrysvo showed 90% effectiveness at preventing the most severe RSV cases in adults 60 years and older.

The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic colorectal cancer and Intercept Pharmaceuticals’ Ocaliva for primary biliary cholangitis.