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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
Serious issues with Medtronic’s nerve monitoring system and Smiths Medical’s ambulatory infusion pumps have prompted software corrections from the two devicemakers, with the FDA assigning the recalls the greatest level of concern. Read More
Sponsors of adaptive AI-enabled medical devices seeking FDA approval should consider submitting a predetermined change control plan (PCCP), according to regulatory attorney Eric Henry of King & Spalding. Read More
CDRH has developed a discussion paper, “Health Equity for Medical Devices,” to gather input from the public on advancing health equity in the context of medical devices. Read More
With the House and Senate now in recess until Sept. 9, the FDA is once again facing into a new fiscal year unsure of its funding from Congress. Read More
Manufacturers of drugs, biologics and medical devices should be harnessing real-world data (RWD) at the postmarket stage, not just to support regulatory compliance but to generate ideas for innovative new products or indications, according to a former FDA official. Read More
Wayne Pines, senior director at APCO Worldwide, a former associate commissioner of the FDA, and a member of the FDAnews Editorial Board, provides his perspective on the likely direction of health product policies after the presidential election in November. Read More
AMCO International Manufacturing & Design received an FDA Warning Letter because automated external defibrillator (AED) replacement batteries made by the firm have not received FDA approval. Read More
The FDA has posted six user fee schedules for FY 2025 on the Federal Register showing increases of up to 44 percent — the highest being for biosimilars. 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
FDA recently added resources for the 2023 guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” to its Guidance Snapshot Pilot Program webpage. Read More
FDA issued a Warning Letter to Criticare Technologies for failure to investigate complaints that its nGenuity patient vital signs monitor — which can be used during surgery — had shut off intermittently. Read More