By several measures, and despite economic hardships leading to layoffs at some companies, the med-tech industry fared well throughout 2022. Financing amounts were greater than nearly every year before the COVID-19 pandemic; deals reached their highest volume to date and mergers and acquisitions did better than most recent years. Read More
The European Union’s efforts to update its regulatory framework for medical devices was heralded as a long-overdue response to the Poly Implant Prothèse (PIP) breast implant scandal, but the COVID-19 pandemic added significant drag to the implementation timelines. Those timelines have proven impracticable for other reasons as well and the problem will bleed into the new year and perhaps beyond to the detriment of patients and manufacturers. Read More
Prenetics Global Ltd. agreed to acquire a majority stake in Act Genomics Holdings Co. Ltd. as part of a move to target the precision oncology market. Prenetics will issue 19.9 million class A ordinary shares and pay $20 million in cash to complete the acquisition. Read More
The U.S. False Claims Act (FCA) provides one of the more potent legal weapons in the federal government’s enforcement arsenal and three companies felt the sting of the FCA in the closing weeks of December 2022. Advanced Bionics LLC fell under the sway of the FCA related to allegations that it misused a performance standard in its premarket filing for cochlear implants, while Biotelemetry Inc. and its Cardionet LLC subsidiary will fork over more than $44 million for improper claims filed with the Medicare program. Read More
A new acute coronary syndrome detection system developed by Neuome Peptides Pte. Ltd.’s aims to make tests for the frequently lethal condition faster, more precise and less invasive. Neuome’s Truheart is a point-of-care assay for cardiovascular disease that is used in the company’s established Instadetect assay development platform. The assay measures the biomarkers troponins I and T and myoglobin. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abiomed, Caredx, Dariohealth, Insightec, J&J, Natera. Read More
