Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.

Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.

It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.

Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.

Sometimes little things can create big problems, which seems to be the case with the recall of the power unit used with the Abbott Heartmate 3 left ventricular assist device (LVAD). According to the FDA recall announcement, the power cords used with the power supply might not stay fixed in place, which would leave the power supply with 15 minutes of backup battery runtime before depletion.

The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.

Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance.

The Sept. 3 congressional hearing on AI in health care raised questions about whether the U.S. FDA enjoys the statutory authorities it needs to properly regulate this class of products, but witnesses at the hearing said a lack of trust in AI is a substantial roadblock to adoption.

Medtronic plc reported that its soon-to-be spun out diabetes business scored two key regulatory wins.

Medtronic plc received U.S. FDA approval for the expanded redo TAVR indication of the Evolut transcatheter aortic valve replacement system. The approval allows for valve-in-valve implantation of a new Evolut valve inside a failed previously implanted TAV made by any manufacturer in patients with severe aortic stenosis considered high-risk for open-heart surgery.