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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Dec. 16, 2019

View Archived Issues
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Boston Scientific scores FDA win with first single-use duodenoscope

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
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Doctors ink mitral valve repair guidelines as CMS eyes Mitraclip coverage

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
Illustration of brain, DNA

Aspen secures $6.5M seed round for autologous neuron replacement in Parkinson’s

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
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First ever comprehensive blood disease research platform to be built for China

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
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French-based data science team develops AI tool for predicting cancer drug approval following phase I trials

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

Appointments and advancements for Dec. 16, 2019

New hires and promotions in the med-tech industry. Read More

Financings for Dec. 16, 2019

Med-tech firms raising money in public or private financings. Read More

In the clinic for Dec. 16, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Other news to note for Dec. 16, 2019

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief. Read More

Regulatory actions for Dec. 16, 2019

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

Regulatory front for Dec. 16, 2019

The latest global regulatory news, changes and updates affecting medical devices and technologies. Read More

Bioworld MedTech’s Cardiology Extra for Dec. 16, 2019

Keeping you up to date on recent developments in cardiology. Read More

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