The U.S. FDA declared that Michelle Tarver is the permanent replacement for Jeff Shuren as the director of the agency’s device center. The news is hardly a surprise as Shuren confirmed the appointment in an October 2024 public meeting.
Baxter International Inc., whose North Cove manufacturing site in Marion, North Carolina, was significantly impacted by the rain and storm surge from Hurricane Helene – including flooding of the facility – in September, reported that restoring the physical facilities has exceeded its expectations, with meaningful advances in site cleanup and remediation.
Legislation that would give the U.S. government a cut of some big pharma profits has once again surfaced in Congress. First introduced in the 114th Congress and every Congress since, the Medical Innovation Act was reintroduced Oct. 18 as a way to tap into the profits of some large biopharma companies to augment research dollars at the FDA and NIH for future drugs and diagnostics, as well as for regulatory science and to support early career scientists.
The U.S. Supreme Court's landmark decision in the case of Loper Bright continues to reverberate across the legal landscape, including in the realm of False Claims Act litigation.
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.
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.
Medtronic plc received U.S. FDA approval to undertake an early feasibility study of its dual-energy Affera cardiac ablation system in sustained ventricular tachycardia. Affera combines both radiofrequency and pulsed field ablation technologies in the Sphere-9 catheter along with high-density mapping.
Nyxoah SA recently raised $27 million after selling three million shares in a bid to shore up its capital base as it prepares to commercialize Genio — its obstructive sleep apnea technology — in the U.S.
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