Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ASP, Camdiab, Fujifilm Healthcare Europe, Vizmark, Ypsomed.
The sea anemone Stichodactyla helianthus, which carpets the Caribbean seafloor, may hold the key to eliminating the senescent cells that survive cancer therapy. A collaboration led by Spanish scientists across several international research centers has discovered a new type of toxin that selectively eliminates senescent cancer cells.
The U.S. FDA’s Jan. 14 webinar for the new Quality Management System Regulation included some fairly predictable content, but one member of the FDA staff mentioned that the agency now expects corporate management to demonstrate the correct “attitude” with regard to product quality, suggesting that agency staff will be more keen to crack down on firms that dispute the agency’s perspectives on quality management.
Boston Scientific Corp.'s Farapoint, its latest pulsed field ablation catheter, received U.S. FDA approval for use as an adjunctive device when treating persistent atrial fibrillation that requires cavotricuspid isthmus ablation, CEO Mike Mahoney reported at the J.P. Morgan Healthcare Conference in San Francisco. The newest member of the popular Farapulse family of PFA catheters provides a focal point option for creation of straight line or focal lesions, complementing the larger, single-shot Farawave catheter that has dominated the PFA market since its U.S. approval in early 2024.
Affluent Medical SAS is becoming Carvolix after it entered into binding agreements to acquire Caranx Medical SAS for €16.6 million (US$19.34 million) and Artedrone SAS for €11.4 million. The aim is to create an integrated med tech company which will focus on revolutionizing cardiac valve replacement and stroke treatment through AI-driven autonomous mini-robots and innovative implants.
The FDA’s Center for Devices and Radiological Health has withdrawn its December 2017 final guidance for clinical evaluation of software as a medical device, a development that seems to align with recent relaxation of digital health product regulation, but which might also be seen as the consequence of an ill-advised case of regulatory copy and paste.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: GT Medical, Lotte Biologics, Rakuten Medical, Rejoni, Tetrascience, Thermo Fisher, Zap Surgical.
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