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Minneapolis-based HistoSonics has filed a de novo application with the US FDA on the use of its Edison Histotripsy System to treat kidney tumors. If granted, it would be the Edison’s first cleared indication outside the liver.

Olympus closed FY2026 with $6.4bn in revenue and plans to cut 2,000 jobs – but the harder story is what remains unresolved: no FDA reinspection date for Aizu, no warning letter clarity and products still on ship-hold stretching into the second half of FY2027.

At its 2026 Diagnostics Day, Roche discussed plans for PathAI and differentiation through early testing in oncology, neurology, infectious diseases and cardiometabolic diseases.

The US FDA issued an update Tuesday on how its recently consolidated Adverse Event Monitoring System affects stakeholders submitting electronic medical device reports. The new AEMS, which the agency rolled out in March, replaced the decades-old MAUDE.

FDA Commissioner Martin Makary ultimately could not overcome White House and special interest anger about some of his policy decisions, including his resistance to approving flavored vaping products.

A pivotal 222-patient study shows Exero Medical's xBar system can detect colorectal anastomotic leaks more than three days earlier than standard care. The company is now seeking FDA clearance, with potential US launch in 2027.