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.

A licensing deal worth potentially up to $1.2 billion with Sanofi SA has breathed new life into Novavax Inc., which has struggled to compete in the COVID-19 space with powerhouses Pfizer Inc. and Moderna Inc.

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.

Medtronic plc teamed up with healthtech software company Modernizing Medicine Inc. (ModMed) to make colonoscopy procedures more efficient by integrating data generated from Medtronic’s GI Genius system into ModMed's gGastro EHR software to enhance endoscopic care.

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.

Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.