“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
Inflammatix Inc. received U.S. FDA breakthrough device designation for its Triverity acute infection and sepsis test system, which produces three readouts that could help emergency physicians quickly determine the proper course of treatment.
Smith+Nephew plc struck a deal to acquire Cartiheal Ltd. for $180 million at closing and $150 million in contingent payments, seven months after Bioventus Inc. backed out of its agreement to buy the developer of the Agili-C cartilage regeneration platform for $450 million.
Day Zero Diagnostics Inc. and Oxford Nanopore Technologies plc (ONT) joined forces to battle the leading cause of death in hospitals — sepsis. Combining Day Zero’s whole genome sequencing technology for pathogen identification and antimicrobial susceptibility analysis with Oxford’s nanopore-based molecular sensing technology, the companies aim to develop a diagnostic system that provides potentially life-saving identification and guidance on antimicrobial selection in mere hours.
Therabionic GmbH received U.S. FDA humanitarian device exemption (HDE) for its P1 device for at-home treatment of hepatocellular carcinoma, which accounts for 80% of all liver cancers, in patients who have failed first- and second-line therapies.
Acutus Medical Inc. revealed plans after the Nasdaq closing bell on Nov. 8 to abandon the electrophysiology business as part of a massive restructuring that will leave the company entirely committed to manufacturing and distribution of Medtronic plc’s left-heart access products. The shift will put 65% of Acutus employees out of work and leaves the future of its cardiac ablation and mapping products up in the air.
The Alzheimer’s Drug Discovery Foundation (ADFF)’s Diagnostic Accelerator launched the first longitudinal, international study of vocal changes associated with Alzheimer’s disease (AD). Part of a $100 million effort to develop affordable biomarkers for AD, the study hopes to create the world’s largest database of speech and vocal data to facilitate diagnosis and monitoring of neurodegenerative disease.
Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
Royal Philips NV received a second round of funding from the Bill & Melinda Gates Foundation to speed adoption of artificial intelligence (AI) algorithms on the Lumify hand-held ultrasound device, bringing its total commitment to the project designed to reduce maternal mortality to $60 million.
Abbott Laboratories received U.S. FDA approval for its molecular human papillomavirus (HPV) screening test, expanding the company’s cancer screening tools. The new member of the Alinity M family of diagnostic assays can be used for screening, as recommended by current guidelines, as well as diagnosis and provide detailed information on the potentially cancer-causing genotypes of the virus.
