In a significant boost to the Edwards Lifesciences Corp. Sapien 3 platform’s market opportunity, the U.S. FDA approved use of the transcatheter aortic valve replacement in patients with asymptomatic aortic stenosis.

The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.

Regulatory reliance is all the rage of late, but some nations employ a four-tier risk classification scheme while others use a three-tier scheme.

The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.

The U.S. FDA’s authority to require cybersecurity measures in premarket submissions is a radical change for industry, but firms must document that they have erected solid cybersecurity measures.

In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.

The use of Renalytix plc’s Kidneyintelx biomarker-based prognostic test led to increased and targeted use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients at risk of diabetic kidney disease, compared to untested patients, according to data from a study.

Staffing cuts at the FDA’s device center led to speculation that the current user fee program may be fatally damaged, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in a meeting in Columbus, Ohio that there are too many resources for FDA at stake for the user fee program to be ended.

The Advanced Medical Technology Association released a policy proposal for AI in medical devices that took the U.S, FDA to task for its guidance for predetermined change control protocols for AI, stating that the guidance is “inconsistent with the statutory authority” for PCCPs.

Medtronic plc’s diabetes unit posted another win with the U.S. FDA approval of the Simplera continuous glucose monitoring sensor for use with the Minimed 780G pump system, helping the company catch up with competitors Abbott Laboratories and Dexcom Inc. Medtronic plans to begin a limited launch of the Simplera Sync in the U.S. this fall.