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.

The ink is barely dry on the draft Medicare physician fee schedule for 2026, but three cardiology societies blasted the draft for cutting rates for left atrial appendage closure procedures – a move they said needlessly endangers patients.

Boston Scientific Corp. received CE mark certification under the Medical Device Regulation for its Intracept intraosseous nerve ablation system, bringing another treatment option to patients with chronic pain.

Understanding neurological disease requires several things, including a clear view of the connectome, and the U.S. National Institutes of Health may have a solution in the form of a new MRI system that allows the user to examine neural connections at the mesoscopic and microscopic scales.

An advisory committee for the U.S. Centers for Medicare & Medicaid Services endorsed a series of patient- and clinician-reported outcomes that might not be reflected in the evidentiary bases for currently available technologies. This development suggests some manufacturers will have to conduct new studies of their devices in order to sustain Medicare coverage.