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. Read More
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. Read More
The Alphafold machine learning system for predicting a protein’s structure from its amino acid sequence has been adapted to make it possible to design de novo proteins that fold in a particular way and bind to prespecified target proteins. The sister system, called Alphadesign, works by generating random strings of amino acids, using Alphafold to predict their structure, and then iteratively optimizing the design. Read More
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. Read More
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. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brain Navi Biotechnology. Read More
