The U.S. FDA device center’s guidance agenda for fiscal 2026 is the classic case of something old and something new, but what was borrowed from FY 2025 may make some blue.

Caught between the start of fiscal 2026 and a congressional funding standoff that shut down much of the U.S. federal government Oct. 1, the FDA will not be able to collect 2026 user fees until Congress agrees on a continuing resolution or a 2026 appropriations bill.

The U.S. FDA’s early alert program has communicated a number of potential device malfunction episodes since its inception in late 2024, but the agency announced that the program is now moving out of the pilot phase to include all device types as of Sept. 29.

Despite down-to-the-wire negotiations, the odds are that parts of the U.S. government will shut down at midnight Sept. 30, as Senate Democrats refused to support a seven-week, clean continuing resolution already passed by the House to keep the government funded while Congress hammers out fiscal 2026 spending bills.

Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.

The U.S. FDA issued a pair of final guidances this week, including one that outlines the criteria for authorizing emergency use of unapproved in vitro diagnostic tests during future public health emergencies and another on software assurance in computer and data processing systems for medical device production.

Heartflow Inc. hasn’t skipped a beat in pumping out good news, with U.S. FDA 510(k) clearance for its next-gen plaque analysis algorithm and platform and Cigna coverage across all lines of coverage starting in October. The new algorithm improves plaque detection 21% compared to the first version of Heartflow’s algorithm.

Medtronic plc received U.S. FDA approval for Altaviva, a minimally invasive implantable tibial neuromodulation device designed to treat urge urinary incontinence. Insertion near the ankle requires neither sedation nor imaging and patients walk out the clinic door with the device already activated.

Organox Ltd.’s normothermic machine perfusion device, Metra, has been cleared by the U.S. FDA for use during air transport. The greenlight from the regulatory body paves the way for the broader use of donor organs that might otherwise be discarded, as the Metra system circulates oxygen and nutrient rich perfusate through the organ at near-body temperature, extending preservation times.