With today’s announcement of its planned acquisition of Bolder Surgical LLC for $160 million, Hologic Inc. continues to execute on the strategy laid out in early January to use the strong cash flow from COVID-19 diagnostics to expand its core business. The Bolder deal, expected to close by Dec. 31, represents the fifth acquisition of 2021. Bolder is a developer of advanced energy vessel-sealing surgical devices. Read More
Feops SA reported that its Heartguide product has received de novo authorization from the FDA for pre-operative planning of left atrial appendage occlusion (LAAo) with the Boston Scientific Corp. Watchman device. The software platform is designed to help physicians virtually model clinical scenarios with different implant positions and sizes of the Watchman device using digital twin technology based on patient-specific virtual replicas of the heart. It is currently commercially available in the EU, U.K., Canada and Australia for transcatheter aortic valve implantation and LAAo workflows. Read More
PERTH, Australia – Australia’s TGA issued new guidance to help device manufacturers better understand new classifications for active medical devices, including software-based medical devices, and clinical decision support software. Read More
PARIS – Teams from the Pitié-Salpêtrière hospital, the Institute for Research in Development, Sorbonne University and the National Institute of Health and Medical Research are proposing a new technique that uses artificial intelligence (AI) to identify the risk of developing a type of cardiac arrhythmia called Torsades de pointes (TdP) associated with taking certain drugs. Read More
The FDA reported Oct. 14 that software used with the Alinity m test kit by Abbott Laboratories is being recalled for the potential for false positive results, a problem due to software used to automate the processing of the test. This recall was originally issued in mid-September, but the Abbott Park, Ill.-based company is advising labs to treat any test result as presumptive at best. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Andau Medical, Detect, Ganymed Robotics, Milestone Scientific, New Al Farwaniya Surgicals and Medical Equipment, Pathai, Roche, Sanolabor. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cepheid. Read More
