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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
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
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 week, the FDA issued rules on new device classifications for SARS-CoV-2 detection devices, devices that detect select microbial agents and some intravenous catheter separation devices. The agency also announced a public meeting to discuss establishment of a Rare Disease Innovation Hub and is seeking comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of eight drug substances. HHS published a proposed regulatory agenda. Read More
Breas Medical has initiated a nationwide correction for 8,186 of its Vivo 45 LS ventilator devices after internal testing identified the potential for short term elevated levels of formaldehyde exposure to users under specific conditions. Read More
A recent FDA Warning Letter illustrates to sponsors the importance of properly managing monitoring responsibilities and having a thorough site activation process. In this article, we’ll examine the letter received by the sponsor of a multisite trial of a device for preventing recurrent ischemic stroke and discuss how problems could have been avoided in the first place. Read More
Abiomed has recalled certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed a company inspection — but were inadvertently released to customers — the FDA announced. 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