The U.S. FDA urged doctors and patients to use CT imaging if possible, when the MRI compatibility of any electronic implanted devices is unknown because problems with CT imaging are "extremely low" in these circumstances.
Boston Scientific Corp. racked up a two-fer from the U.S. FDA with approval of its navigation-enabled Farawave Nav ablation catheter and 510(k) clearance for the Faraview software for use with its Farapulse pulsed field ablation (PFA) system.
In what represents the first patenting from Cerathrive Ltd., its co-founder and CEO, Sarah Turner, describes their development of the Cera system, which they claim to be the first and only U.S. FDA-cleared red-light device that targets the gut-brain axis to improve focus and energy levels.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angiodynamics, Cvrx, Endospan, Heartflow, Hemosonics.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Roche, Thermo Fisher Scientific.
The speculation as to the status of Michelle Tarver, the acting director of the U.S. FDA’s device center, is officially over despite disclaimers at. The outgoing director, Jeff Shuren, said Tarver “will make a great center director” in remarks during an Oct. 17 public appearance, thus cementing Tarver’s role at FDA.
Nowdiagnostics Inc. established an exclusive agreement with Labcorp Holdings Inc. for distribution of its First To Know syphilis test in the U.S. The test provides results in 15 minutes with as little as a single drop of blood. The test will be available to hospitals and clinicians by the end of 2024 and offered to patients directly through Labcorp Ondemand in 2025.
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