Boston Scientific Corp., of Marlborough, Mass., has won the U.S. FDA’s nod for the Exalt Model D single-use duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. It is the first single-use duodenoscope on the market and earlier secured breakthrough device designation. “Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. Read More
While the U.S. Centers for Medicare and Medicaid Services (CMS) revisits its coverage policy for transcatheter mitral valve repair devices, several physician societies have drafted recommendations for operator and institutional volume requirements that could restrict the number of centers authorized to practice devices such as Abbott Park, Ill.-based Abbott Laboratories’ Mitraclip. Read More
Aspen Neuroscience Inc. hopes to get into the clinic to test autologous neuron replacement in Parkinson’s disease with a $6.5 million seed round. The financing featured several established life sciences venture investors; it was led by Domain Associates and Axon Ventures and included Alexandria Venture Investments, Arch Venture Partners, Orbimed, and Section 32. Read More
HONG KONG – Boston-based consulting firm Analysis Group Inc. will be working with China’s Institute of Hematology & Blood Diseases Hospital (IHBDH) on developing a first-of-its-kind blood disease research platform. The National Longitudinal Cohort of Hematological Diseases in China (NICHE) is set to hold the information of more than 10,000 patients across China. Read More
PARIS – A team of medical researchers and engineers from the Gustave Roussy Institute, in Villejuif, France, and Paris-Sud University recently developed an artificial intelligence system called Resolved2, designed to assess prospective cancer drugs. As Loïc Verlingue, lead cancer specialist on the data science team at the Gustave Roussy Institute, explained to BioWorld MedTech, “this AI is intended to predict efficiently whether a cancer treatment molecule will achieve authorization or not within six years of pharmacological data and phase I clinical trials.” Read More
