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This week, the FDA published three medical device classifications — clinical chemistry and clinical toxicology devices, gastroenterology-urology devices and immunology and microbiology devices. The agency also published draft strategy on innovative manufacturing technologies. Comments are being sought on integrated review documentation for development of new drugs. Read More
This edition of Quick Notes features the FDA approval of Renata Medical’s child-tailored Minima Growth Stent, 510(k) clearances of Embecta’s disposable insulin patch pump and ID-FISH Technology’s Lyme disease diagnostic and EU approval of AngioDynamics’ laser atherectomy system. Read More
During the second session of the 118th Congress, FDAnews will track important pending legislation, that has been acted on by Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
This edition of Quick Notes features FDA approval of Neuros Medical’s electrical nerve stimulation device, clearance for Clearmind Biomedical’s neuroendoscopy system for minimally invasive neurosurgery, approval for Illumina’s cancer biomarker test with two companion diagnostics, and clearance for OxiWear’s oxygen data collection device. Read More
This week, the FDA published eight medical device classifications — cardiovascular, dental (2), hematology and pathology, neurologic, ophthalmic, orthopedic and physical medicine. Final guidance was issued on nitrosamine impurities. The agency also asked for information for future guidance on model-informed drug development. Read More
This edition of Quick Notes features announcements of UCB’s divestiture of its Chinese neurology and allergy business and collaborations between Bayer and NextRNA, Flagship Pioneering and Pfizer, and Adcendo and Multitude Therapeutics. Read More
This edition of Quick Notes features FDA clearances that expand the indications of a device to treat Type 2 diabetes, label changes that eliminate aspirin use for heart pump patients, use AI and robotics to treat enlarged prostates, and a new device to collect bone marrow aspirate. Read More
This edition of Quick Notes provides approval notes on Janssen’s and AstraZeneca’s treatments for non-small cell lung cancer, FDA’s clinical hold on BioNTech’s HER3 anti-drug conjugate and “tentative” approval of Yutrepia. Read More
This edition of Quick Notes features announcements of J&J’s acquisition of V-Wave, Paragonix Technologies’ sale to Getinge, Dupont’s purchase of Donatelle Plastics and Stryker’s deal to buy Vertos Medical. Read More
This edition of Quick Notes provides approval notes on treatments for hypoparathyroidism, prurigo nodularis, primary biliary cholangitis and graft-versus-host disease. Read More
This edition of Quick Notes features FDA’s approval of implantation of Medtronic’s neurostimulators for deep brain stimulation in sleeping patients, a De Novo clearance for SoClean’s bacterial reduction system for CPAP hoses and masks, an expanded clearance for Guard Medical’s orthopedic surgical dressing, and an update on Tandem Diabetes Care’s insulin pump app for Apple iOS devices. Read More