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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
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
This edition of Quick Notes looks at FDA approvals and clearances for devices involving digital pathology images, implantable device protective pockets, and measurement/monitoring systems for obstetrical and cardiac care. Read More
To help the drug and device development industries account for human factors (HF) in their combination product trials, the FDA is releasing draft guidance on employing use-related risk analysis (URRA), a risk management tool that supports the HF engineering process. Read More