“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. Read More

Novocure Ltd. will lay off 13% of its workforce as part of plans to restructure its business and reduce operating expenses by $60 million. Read More

Brainspec Inc. received U.S. FDA 510(k) clearance for use of its artificial intelligence platform, Brainspec Core, in noninvasive measurement of brain chemistry using magnetic resonance spectroscopy (MRS). Read More

Philips Respironics Inc.’s nightmares with its Dreamstation continuous positive airway pressure (CPAP) line of products continued with a fresh warning from the U.S. FDA of reports involving thermal issues with a newer iteration of the machine, some of which cited patient injuries. Read More

Researchers at the University of California, Davis (UC Davis) have developed a method of biofluid assessment capable of real-time monitoring as well as compatible with machine learning and neural network processing.

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New hires and promotions in the med-tech industry, including: Bioskryb Genomics, Exthera, Perigen. Read More

Med-tech firms raising money in public or private financings, including: Savage. Read More

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Orthofix, Pixcell. Read More

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ennocure, Inspira, Penumbra, Plaquetech, Revalve, Trinity Biotech. Read More

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CTL Amedica, Icecure Medical, Zilia. Read More