The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program.

Profound Medical Corp. received U.S. FDA 510(k) clearance for its second transurethral ultrasound ablation (TULSA) module using artificial intelligence. When used with Profound’s TULSA-Pro system, the Contouring assistant helps physicians more quickly and accurately segment prostate imaging and design treatments.

Is the U.S. getting the best return on investment (ROI) for its NIH buck? That’s the basic question at the heart of a white paper Sen. Bill Cassidy (R-La.) issued May 9 to continue a conversation he started in September on the reforms needed at the country’s premier biomedical research institution.

The U.S. FDA has taken off the gloves when it comes to device warning letters. One recent example is the April 3 warning letter to Bioptimal International Ltd., of Shenzen, China, which did not score well with the agency on routine good manufacturing practices. Perhaps more conspicuous was that the company was selling catheters that had undergone significant changes without a new regulatory filing – a seemingly common theme in recent FDA device warning letters.

Route 92 Medical Inc., of San Mateo, Calif., reported a class I recall of nearly 1,000 microcatheters because of reports of separation of the distal tip of the catheter, which is associated with two injuries and one reported death. The company indicated that the problematic catheters had been manufactured by an unidentified contract supplier, once again highlightingthe hazards of a failure to properly oversee the contract manufacture of critical medical devices.

Ajax Therapeutics Inc. has received clearance for its IND application from the FDA to initiate a phase I study of AJ1‑11095, a first-in-class type II JAK2 inhibitor, for the treatment of patients with myelofibrosis.

The U.K.’s world-first subscription model for antimicrobials is to be expanded following a successful pilot scheme in which companies are being paid a fixed annual fee for their drugs, regardless of the volume dispensed.

SN Bioscience Co. Ltd., headquartered in Seongnam-si, Gyeonggi-do’s second Pangyo Valley, gained U.S. FDA fast track designation for SNB-101 (SN-38), its new polymer nanoparticle cancer drug candidate for small-cell lung cancer.

The U.S. FDA’s final rule for lab-developed tests was a long time in coming even if the agency shorted the public comment period for the draft rule, and the final rule makes several major concessions about circumstances in which the agency would exercise enforcement discretion.

Imaging is the number one way physicians track cancer progression and burdens within neurology and cardiology, but the ability to take imaging information and interact with it to make better decisions is becoming ever more complicated.