A pair of co-published filings from Naples, Fla.-based Aerwave Medical Inc. describe apparatus and ultrasound-based methods for bronchial denervation, ablating smooth muscle or goblet cells, and emphysematous tissue remodeling in the treatment of respiratory conditions such as asthma and chronic obstructive pulmonary disease.

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.

AC Immune SA has landed a potential $2.2 billion deal for its anti-amyloid beta Alzheimer’s disease vaccine, ACI-24.060, with Takeda Pharmaceutical Co. Ltd., under which it will get $100 million up front and is eligible to receive an option exercise fee, plus potential development, commercial and sales-based milestones of up to $2.1 billion.

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.

One-year results of the DETOUR2 trial published in the Journal of Vascular Surgery demonstrate outstanding results for Endologix LLC’s percutaneous transmural arterial bypass system for treatment of severe peripheral artery disease. The study showed nearly all patients experienced improvement in acute limb ischemia with freedom from occlusion of 92% and freedom from revascularization of nearly 88% at 12 months.

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.

AC Immune SA has landed a potential $2.2 billion deal for its anti-amyloid beta Alzheimer’s disease vaccine, ACI-24.060, with Takeda Pharmaceutical Co. Ltd., under which it will get $100 million up front and is eligible to receive an option exercise fee, plus potential development, commercial and sales-based milestones of up to $2.1 billion.