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After half a century of serving the regulatory information needs of the pharmaceutical, medical device and biologics communities, FDAnews presents the final issue of its flagship publication today. 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
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
The FDA’s efforts to actively oversee the safety of medical devices after they’ve hit the market have begun to bear fruit, with the agency making strides toward setting up a postmarket surveillance system and planning to kick it into gear by the end of 2024, a Government Accountability Office (GAO) analysis finds, but two core challenges remain. Read More
In this edition of Quick Notes, we cover FDA nods for a new sterilization method for duodenoscopes, an updated device for sleep apnea, a smaller continuous glucose monitor and a digital therapy for insomnia. Read More
Cresilon has received FDA clearance for its plant-based hemostatic gel technology Traumagel to be used to stop and control life-threatening bleeding in a matter of seconds when applied to a wound at the point of care. Read More
This edition of Quick Notes features clearances for a mini robotic system, peripheral arterial disease and peripheral vascular disease testing devices, testing assays for the evaluation of monoclonal gammopathy and breakthrough device designation for a posterior cervical system for treatment of the cervical and upper thoracic spine. Read More
CMS has issued a final procedural notice outlining a Medicare coverage pathway — Transitional Coverage for Emerging Technologies (TCET) — for certain FDA Breakthrough Devices to be covered under Medicare. Read More
The FDA has approved Guardant’s Shield blood test for colorectal cancer (CRC) screening in adults aged 45 and older who are at average risk for the disease. Read More
In this edition of Quick Notes, Abbott’s correction for Freestyle Libre 3 sensors, a new FDA webpage for LDTs, 510(k) clearance for Imperative Care catheters and eCential Robotics’ clearance for spine navigation and robotic-assistance device. Read More
This edition of Quick Notes includes FDA clearance for a Signum Surgical anal fistula treatment, a CE Mark for a Roche CGM system, 510(k) clearance of an augmented reality technology platform for use in operating rooms and a software update for ultra-low field brain images. Read More