Alucent Biomedical Inc., which is developing a restorative therapy for peripheral artery disease (PAD), completed a $35 million series B financing led by a multinational strategic investor. The funds will be used to complete clinical studies of the Alucent Natural Vascular Scaffolding (AlucentNVS) vessel restoration system with photoactivated linking, the company’s first product.
The Medicare clinical lab fee schedule (CLFS) in the U.S. has gone through some twists and convolutions in connection with the rate reset effort, but the suite of expensive, high-end tests is another source of spending concern. The Medicare Payment Advisory Commission (MedPAC) examined that question recently and is considering several possible solutions. Among these are a fixed-rate deflation metric from a starting price point and bundling with a provider’s bundled payment program, two possible solutions that each carry their own set of headaches.
PARIS – Gleamer SAS has secured $8.75 million in series A financing for its CE-marked artificial intelligence (AI) application that automatically detects all types of fracture in radiography. “This funding will allow us to move forward with launching Boneview around the world,” Christian Allouche, CEO and co-founder of Gleamer, told BioWorld.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking industry feedback on further strengthening reforms for adverse events and postmarket regulations for medical devices.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Covidien, Medtronic, Newport Medical, Royal Philips.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beckman Coulter, GI Windows, Itamar Medical, Medtronic, Orthofix, Pulse Biosciences, Teleflex, Vascular Graft Solutions.
Med-tech firms raising money in public or private financings, including: Anpac Bio-Medical Science, Sophia Genetics, Tissium, Varex Imaging, Well Health Technologies, Wise.
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