The U.S. FDA has staked out a position on the use of per- and polyfluoroalkyl substances in medical devices, declaring that the evidence offers no reason to restrict their continued use in med-tech products.

The U.S. Centers for Medicare & Medicaid Services adopted several significant policy changes in the Medicare inpatient final rule for fiscal 2026, which includes a larger rate bump for hospitals than seen in the draft.

Olympus Corp.’s “active investment” in endoluminal robotics has materialized in a new joint venture med-tech called Swan Endosurgical Inc., with Revival Healthcare Capital LLC.

The U.K. National Institute for Health and Care Excellence updated its guidance for the use of single-procedure insertion of scaffolds for knee cartilage repairs, specifying that only qualified surgeons should perform the procedure.

Negotiations for the sixth U.S. FDA device user fee agreement (MDUFA VI) are officially underway, and the Aug. 4 meeting highlighted some of the differences between the agency’s and industry’s expectations.

The FDA announced July 17 that Dexcom Inc. recalled a series of continuous glucose monitor receivers for a failure of speakers to issue an alert for out-of-specification blood glucose measures. This is a clear demonstration of the principle that greater device functionality often creates new types of risk.

While inflation in the U.S. is hovering below 3%, increases in some FDA user fees for fiscal 2026 are tripling that rate. PDUFA fees for branded prescription drugs and biological products will see a 9% hike come Oct. 1, and the increase in MDUFA fees will more than double the inflation rate with a 7% hike across the board.

The U.S. Department of Justice announced July 31 that Illumina Inc. agreed to pay $9.8 million to settle allegations it sold genomic sequencing equipment that suffered from cybersecurity problems. The settlement concludes a qui tam lawsuit filed by a former employee and highlights the hazards of poor cybersecurity for med-tech firms.

The U.S. Federal Trade Commission announced a $14.6 million grant it received for an upgrade of its IT infrastructure. The same grant mechanism is leveraged by the Department of Justice, which is a clear sign that U.S. enforcement will be more vigorously enabled by sophisticated analytics going forward.

Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.