The clearance is the first ever for an oral appliance, along with a mode of respiratory ventilation or exercise training program for the muscles around face, mouth and tongue, to treat moderate and severe OSA in adults.
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Philips shares fell more than 6% on Wednesday after the U.S. Food and Drug Administration said it is alerting patients of a new safety issue with machines made by the group that are used for the treatment of obstructive sleep apnea.
The primary objective of the study is 180-day post-implantation survival without disabling stroke or successful heart transplant within 180 days of implantation, the company said.
The Curry Rockefeller Group (CRG) is a full-service medical communications company, based in Tarrytown, NY.
Healthware will immediately merge with EVERSANA INTOUCH, shifting from long-standing partnership to a full-service global, award-winning agency network.
The European Commission is carrying out unannounced inspections at the premises of an unnamed medtech company.
The deal will help Danaher bulk up in the face of a funding crunch among small-sized biotech companies that has dented demand for its products used to develop treatments and vaccines.
One of the world’s largest manufacturers and distributors of medical and surgical products such as needles, syringes and sharps disposal units is the latest company to benefit from an ongoing recovery in demand for non-urgent surgical procedures.
ConTIPI’s expanded agreement with Indegene includes several services across the commercialization process, including sales, PRMA (pricing, reimbursement and market access), medical affairs, medical communications, pharmacovigilance, regulatory, marketing and commercial operations support.