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Coloplast has signed a $1.3 billion agreement to acquire Kerecis, a biologics wound care manufacturer based in Iceland, with an FDA-cleared patented technology platform based on intact fish skin. Read More
The FDA has classified Draeger Medical’s Oxylog 3000 Plus emergency and transport ventilator as class I, the most serious type of recall because of the risk of serious injury or death. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
The first wireless pulse-oximetry device for infants has received an FDA 510(k) clearance after first receiving a warning letter for selling the device without the agency’s clearance or approval. Read More
New FDA drug approvals in June include new gene therapies for ambulatory Duchenne Muscular Dystrophy and hemophilia A, a treatment for pediatric growth hormone deficiency and the first ever cell therapy for a severe form of type 1 diabetes. Additionally, the FDA approved a new device for skin repigmentation in patients with vitiligo. Read More
CDRH’s new development initiative — Total Product Life Cycle Advisory Program (TAP) — taps into an FDA goal: to ensure U.S. patients are first to benefit from innovative medical devices that, while developed quickly, are of high quality, safe and proven effective, and that include input from patients, providers and payers early in the process. Read More
Nearly 20 percent of AI and machine learning (ML) devices in a study had discrepancies between FDA-cleared indications for use and information included in marketing materials, according to a report published Wednesday in JAMA Open Network.. Read More
The FTC’s amicus brief in a product-bundling case has “broad implications for antitrust enforcement in the healthcare sector and beyond,” the FTC says, regarding its analysis of Medtronic’s motion to dismiss in a case that also involves exclusive-dealing. Read More