Continuous glucose monitors continue to post positive results for managing diabetes in an ever-expanding population. Long a mainstay of disease management for those with type 1 diabetes, the devices have also proved themselves in treating type 2 diabetes that requires multiple daily injections of insulin. Read More
Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU. Read More
Radiopharm Theranostics Ltd. announced a AU$70 million (US$46.69 million) institutional placement, and as part of that capital raise, radiopharma company Lantheus Holdings, Inc., has agreed to make an initial equity investment of AU$7.5 million. Read More
The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles for these products. Read More
Sometimes a court cites long-standing precedent in deciding how to handle a case, but the U.S. Court of Appeals for the Federal Circuit leveraged a decision it rendered only last year in deciding a patent case between Apple Inc., and Omni Medsci Inc. Read More
After receiving a complete response letter (CRL) in 2023 related to device issues, North Chicago-based Abbvie Inc. received another CRL for ABBV-951 (foscarbidopa/foslevodopa) for treating motor fluctuations in advanced Parkinson’s disease, this time for issues at a third-party manufacturer. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Cranius, GE Healthcare, Ricoh, Stratasys, T2 Biosystems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Tempus. Read More
