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This edition of Quick Notes reviews the FDA’s approval of Abbott’s transcatheter repair system, Spirair’s nasal septal deviation correction device, de novo approval of Orthobond’s antibacterial coating, and 510(k) clearance of Olympus’ single use ureteroscope system. Read More
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Read More
A genetic risk assessment for opioid addiction approved by the FDA “may make the opioid crisis worse,” according to 31 physicians, researchers and scientists who ripped the agency and the test in a scathing letter Thursday to Commissioner Robert Califf, requesting the approval be revoked. Read More
The first-ever sepsis diagnostic powered by AI has been granted De Novo marketing authorization by the FDA, addressing a decades-long and expensive challenge for the U.S. healthcare system — rapid diagnosis and prediction of sepsis. Read More
Seeking to get back on track for FDA approval of its first-of-a-kind epinephrine nasal spray, ARS Pharmaceuticals says it has provided the agency with responses to all its additional requests in the Complete Response Letter (CRL) the agency send ARS last September. Read More
An FDA advisory committee on Thursday gave its unanimous blessing to Balance Opthalmics’ FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) system as a nightly use adjunct therapy for reducing intraocular pressure in adults with open-angle glaucoma and intraocular pressure 21 mmHg or less. Read More