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.

Full-Life Technologies Ltd. announced Sept. 29 the completion of a $77 million financing, comprising $50 million in series C equity and $27 million in debt financing, which will be used to advance a portfolio of radiopharmaceuticals and radionuclide-drug conjugates worldwide.

Ernst & Young LLP didn't quite declare the patient cured but saw signs of a strong med-tech recovery after a few years on life support in its annual Pulse of the MedTech Industry report. The global accounting giant particularly called out strength in the cardiovascular, diabetes, robotics and orthopedics segments.

Roche Holdings AG reported results from its TSIX study which demonstrated that its sixth-generation Troponin T test is accurate at diagnosing heart attacks not only in men but also women. Recently granted CE mark, the Elecsys Troponin T hs Gen 6 test, demonstrated it was able to identify acute myocardial infarction (AMI) and identify those not having an AMI, with a high level of precision, ensuring that patients receive the care they need at the earliest opportunity.

Palmetto GBA, the Medicare administrative contractor for most of the southeastern U.S., has opened a coverage analysis for the use of irreversible electroporation for a variety of cancers, but Palmetto has made it clear that it is unwilling to cover the procedure pending additional evidence.

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.