Haemonetics Corp. returned to the M&A trail with an agreement to buy Opsens Inc., a cardiology-focused medical device company, for CA$2.90 (US$2.13) per share for a total of CA$345 million (US$253 million). The all-cash transaction, its third significant purchase in five years, is expected to close by late January 2024, pending the approval of regulators and 66.66% of voting shareholders. Haemonetics expects the deal to be immediately accretive to adjusted earnings per share (EPS). Read More
Concerns over the EU’s agonizingly clunky roll-out of the Medical Device Regulation (MDR) has largely focused on the capacity of notified bodies to manage the task of recertifying CE marks for legacy devices, but a new problem has emerged that promises to add yet more drag to the process. Amie Smirthwaite, senior vice president for innovation at RQM+, said EU member states’ competent authorities seem bent on pressing notified bodies (NBs) to treat guidance by the Medical Device Coordination Group (MDCG) as regulation, with the net result that “you almost need guidance for the guidance” in order to successfully navigate the EU market. Read More
The U.S. FDA 510(k) clearance of Airamed GmbH’s Airascore software could see millions of people benefitting from early accurate diagnosis of Alzheimer’s disease and other types of dementia. Airascore is a medical image management and processing system that uses deep learning and artificial intelligence (AI) to assess brain volumetry data on MRI scans in as little as five minutes. Read More
For individuals who develop an unexpected psychosis, there is something to be said for testing them for autoimmune antibodies. And something against. At the 36th Congress of the European College of Neuropsychopharmacology (ECNP) this week, the topic was worth a controversy session, where speakers presented the pros and cons of the approach. Currently used tests have a specificity of 99%. But as Ester Coutinho, consultant neurologist at the University of Coimbra, pointed out, the validity of diagnostic tests depends on the prevalence of the disorder one is looking for as well. Coutinho estimated that autoimmune psychoses account for 1% of psychoses overall. Read More
The U.S. FDA’s final guidance for clinical decision support (CDS) systems may be the subject of two citizen’s petitions requesting the agency scrap the guidance and start over, but that doesn’t mean the agency is not enforcing the terms of the guidance. Danvers, Mass.-based Abiomed Inc., took in a Sept. 19 warning letter stating that the company’s Impella Connect system qualifies as a CDS product because it provides “patient-specific medical information to detect a life-threatening condition,” an interpretation that is sure to intensify the larger debate about whether the CDS final guidance is an extra-statutory exercise in regulatory engineering. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M Health Care, Belle.ai, Biocardia, Creative Medical, Femasys, Fibronostics, Mediwound. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Intelivation Technologies. Read More
