Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomérieux, Cequr.
New hires and promotions in the med-tech industry, including: Advanced Bionics, Alcanza Research, Avita Medical, Body Vision Medical, Ostial Corp., Stryker.
The U.S. FDA posted notice of a recall of the system monitor for the Heartmate left ventricular assist device by Abbott Laboratories, an action necessitated by reports of a series of malfunctions that may lead to inadvertent operator error.
After snaring the U.S. FDA’s approval for the Evoque tricuspid valve device, Edwards Lifesciences Corp. petitioned the Centers for Medicare & Medicaid Services for a national coverage determination for transcatheter tricuspid valve replacement devices.
Alcon AG completed the acquisition of Belkin Vision Ltd. with an upfront consideration of $81 million with an additional $385 million in contingent payments. With the deal, Alcon gets its hands on Belkin’s U.S. FDA-cleared direct selective laser trabeculoplasty device, expanding its treatment options for patients with glaucoma.
Merit Medical Systems Inc. acquired the Esophyx Z+ device from Endogastric Solutions Inc. for $105 million in cash, adding a durable, non-pharmacological treatment for gastroesophageal reflux disease to its line-up of gastrointestinal products.
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