The U.S. Centers for Medicare and Medicaid Services (CMS) capped off the month of August 2020 with one of the more significant Medicare coverage documents in recent memory. The more immediately impactful part of the proposed rule would offer immediate coverage for devices approved or cleared under the FDA’s breakthrough devices program, but the broader element of this proposed rule offers a definition for the term “reasonable and necessary,” a development that itself constitutes a breakthrough in the world of Medicare coverage of medical technology. Read More
Baxter International Inc. has scored a win from the U.S. FDA, which has granted the de novo application for Theranova, the company’s novel dialysis membrane. For his part, Cowen’s Josh Jennings noted that de novo designations are rare in the dialysis space, echoing a company statement. “We think the de novo classification strengthens any argument for the uniqueness of the technology, which should help its commercial experience,” he added. “BAX had expected an FDA clearance in [second half of] '20, so this action falls on the early end of that range.” Read More
Neuropace Inc. has scooped up $67 million in a financing round that was led by Accelmed Partners. The funds will be used to accelerate commercial growth of its brain-responsive neurostimulator (RNS), as well as to advance new indications for the U.S. FDA-cleared system. Read More
The FDA came through at last for Athlone, Ireland-based Innocoll Holdings Ltd., greenlighting the drug-device combo Xaracoll (bupivacaine HCl) for acute postsurgical pain relief for up to 24 hours in adults after open inguinal hernia repair. Read More
PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Coghlin Companies, Cogmedix, Concord Medical, Dominion Aesthetics, Formsense, Genesis Medtech, Nowdiagnostics, Ontrak, Todos Medical. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dialco, Masimo. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: The International Contrast Ultrasound Society. Read More
Keeping you up to date on recent developments in cardiology, including: 3D printing of heart valve models; Findings challenge recommendations for antiplatelet treatment after TAVI; Telehealth could help those with high BP avoid heart attack, stroke. Read More
