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. Read More
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. Read More
Genetron Holdings Ltd., a Beijing-based precision oncology company, has gained breakthrough device designation status from the U.S. FDA for its blood-based, next-generation sequencing test for the early detection of hepatocellular carcinoma (HCC). The test, called HCCscreen, is intended for individuals at high risk for HCC due to chronic hepatitis B virus infection or liver cirrhosis. Read More
DUBLIN – The ongoing legal uncertainty surrounding the transfer of data from European research institutions or companies to international partners shows little sign of resolution, despite the urgency of the COVID-19 pandemic, which has engendered an extraordinary collaborative response from the global scientific community. Read More
FDA enforcement of clinical research regulations has often been "light-handed, slow-moving, and secretive," a new look at the agency's enforcement track record concludes. Published today in the journal Science, the analysis said the shortcomings may be harming both patients and trial integrity. Read More
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. Read More
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. Read More
Med-tech firms raising money in public or private financings, including: Anpac Bio-Medical Science, Sophia Genetics, Tissium, Varex Imaging, Well Health Technologies, Wise. Read More
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. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Covidien, Medtronic, Newport Medical, Royal Philips. Read More
Keeping you up to date on recent developments in diagnostics, including: Brain imaging reveals signs of childhood trauma; Buyer beware for SARS-CoV-2 antibody detection; Tumor-associated cell cluster signal cancer alert. Read More
