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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Electrocore, Icecure Medical, Seastar Medical, Vivos Therapeutics. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Aidoc Medical, Alcon, Holberg EEG, Labcorp, Natus, Reflow Medical, Relief Cardiovascular, Roche, Spotitearly, Staar Surgical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Outlook, Roche, Uroviu, Zenflow, Zoll. Read More
