Boston Scientific recalls (Class 1) its POLARx and POLARx FIT Cryoablation Balloon Catheters because of atrio-esophageal fistula risks.
LivaNova says its aura6000 obstructive sleep apnea treatment met the safety and efficacy endpoints in the OSPREY trial in adults.
GAO healthcare director Mary Denigan-Macauley says FDA needs a plan and a strategy for recruiting and retaining new facility inspectors.
FDA clears a GE HealthCare 510(k) for its Signa Magnus, a 3.0T high-performance, head-only MRI scanner.
FDA warns Mechanicsville, VA-based American Contract Systems about Quality System Regulation violations in its manufacturing of sterile convenience ki...
FDA warns Chinas Zhejiang Qimei Cosmetic Co. about CGMP violations in its manufacturing of OTC drugs.
FDA accepts for review an Abeona Therapeutics BLA resubmission for prademagene zamikeracel (pz-cel), a gene therapy for patients with recessive dystro...
Federal Register notice: FDA determines that Nuplazid (pimavanserin tartrate) tablet (equivalent 17 mg base) was not withdrawn due to safety or effect...
