The success of new year’s resolutions for 2023 won’t be known for months to come, but from the vantage point of December, it is easy to see that many large med-tech companies resolved to shed excess weight in 2022 – and did so in dramatic fashion. Some big-name players decided that they would be more agile, and better rewarded by shareholders, with a trimmer portfolio, while others saw value in setting internal operating units free as new companies. As part of our year in review, BioWorld looks at the big deals, the new companies and the impact of all these actions on 2023. Read More
Congress has wrapped up the budget for fiscal year 2023 with yet another significant boost to funds for the National Institutes of Health, but the omnibus legislation also authorizes the U.S. FDA to designate academic research centers as centers of excellence for continuous drug manufacturing. A conspicuous omission from the omnibus was the Verifying Accurate, Leading-edge IVCT Development (VALID) Act for FDA regulation of lab-developed tests (LDTs), an omission that drew both praise and criticism from stakeholders. Read More
Carmat SA just completed a flash fundraising of $33 million to increase production of its Aeson total artificial heart and support sales growth in Europe. The operation featured two distinct but concurrent actions: a reserved offer and a public offer. The reserved offer, intended for specialist investors, raised $28.9 million. Read More
Seekin Inc.’s cancer mutation detection kit Pancanseek for leukemia patients has received a CE-IVD mark, expanding the company’s reach in the testing space. Read More
Continuous positive airway pressure (CPAP) devices made by Philips Respironics Inc. are still presumed by the U.S. FDA and other regulators to present a health hazard to patients, but the company’s latest data seem to suggest otherwise. In a Dec. 21 statement, the Royal Philips subsidiary said that testing suggests no appreciable harm to health related to particulate matter emissions from the polyester-based polyurethane (PE-PUR) foam in these devices, and that there is no evidence of long-term harm associated with volatile organic compounds (VOCs), both of which are conclusions with which the FDA may not agree. Read More
Med-tech firms raising money in public or private financings, including: Htg Molecular Diagnostics, Icecure Medical, Perception Vision Medical Technologies. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Si-Bone. Read More
