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. Read More
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. Read More
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. Read More
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. Read More
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. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Angiodynamics, Cvrx, Endospan, Heartflow, Hemosonics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Roche, Thermo Fisher Scientific. Read More
