Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, BD, Centogene, Cochlear, Inmode.
Carag AG received investigational device exemption (IDE) approval from the U.S. FDA for its Carag Bioresorbable Septal Occluder (CBSO). The device is the first transcatheter septal occluder with a nonmetal, bioresorbable framework. The Baar, Switzerland-based company plans a "swift start" for a staged study trial in the U.S. with 250 patients, Carag's CEO Jérôme Bernhard told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Life Whisperer, Phosphorus, Sagico, Spinal Elements.
The U.S. Centers for Medicare and Medicaid Services (CMS) posted the much-anticipated draft do-over of the mitral valve repair device coverage memo, and in the process renamed the policy the mitral valve transcatheter edge-to-edge repair (TEER) national coverage memo.
Orthopedic implant startup Engage Surgical has received 510(k) clearance from the FDA for its Engage Partial Knee system, the only cementless partial knee implant available in the U.S. The company is introducing the product via a limited release to select surgical centers.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axonics, Carag, Engage Surgical, Guided Therapeutics, Kdx Diagnostics, Venus Concept.
The push for a vaccine for the COVID-19 pandemic may have no parallel in pharmaceutical history, and FDA commissioner Stephen Hahn vowed in a Senate hearing that the agency will rely on the agency’s traditional standards for scientific evidence in premarket reviews of those vaccines.
The U.S. FDA has greenlighted Ancora Heart Inc.’s IDE request to conduct the Corcinch-HF pivotal clinical trial. The study is intended to demonstrate the safety and effectiveness of the Accucinch ventricular restoration system in patients with heart failure and reduced ejection fraction (HFrEF).
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