After years of conversations surrounding indirect research costs, academic groups are now under the gun to quickly come up with an alternative to the NIH’s proposed 15% across-the-board cap on indirect costs and the decades-old university-by-university negotiated rate that can exceed a 50% add-on to a grant.
Chinese researchers are preparing the details for the publication of another scientific milestone, the creation of a chimera with a human heart and a kidney developed from human stem cells in pig embryos.
Two med-tech companies focused on pulmonary embolism overcame their own blockages to commercialization this week. Inquis Medical Inc.’s Aventus thrombectomy system received U.S. FDA clearance for use in pulmonary embolism, an expanded indication, while Penumbra Inc. completed enrollment in the STORM-PE clinical trial of its Lightning Flash device.
The U.S. Centers for Medicare & Medicaid Services finalized a coverage policy for at-home ventilation for patients with chronic respiratory failure. The amended policy also establishes a series of criteria for coverage of ventilation for chronic obstructive pulmonary disease.
It appears the U.S. FDA believes it’s never a bad time to release regulatory information about devices granted market access via the de novo program. The agency recently posted information on the vintage de novo granted in 2018 to Imagen Technologies Inc. for the company’s Osteo Detect algorithm.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adona Medical, Ainnova Tech, Avant Technologies, Castle Biosciences, Cathvision, Grupo Dökka, Hera Biotech, Hera Diagnostics, Scibase.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brain Navi Biotechnology.