US FDA Sheds Light on Digital Health Technology Plans
August 4, 2017
By Neozene

Medical device regulators at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) have published further details on their plans to clarify and improve policies regarding mobile medical applications, wearables and other digital health products. Announcing what they’re calling the Digital Health Innovation Action Plan, CDRH officials have identified three key components of the plan: More guidance addressing the 21st Century Cures Act’s medical software mandates, a new pilot precertification program (FDA Pre-Cert for Software) for digital health product regulatory oversight, and expanding US regulatory expertise

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Does Puma’s quick Nerlynx launch play into its buyout prospects?
August 1, 2017
By Neozene

Just two weeks after winning FDA approval and one month ahead of its previous launch timeline, Puma Biotechnology has introduced new breast cancer medication Nerlynx to the market. The company’s quick move to hit the market is raising questions about how likely a buyout will be for the drugmaker. Without disclosing price, Puma said in a Monday announcement that Nerlynx is commercially available in the U.S. The development comes a month ahead of the company’s previous plan to launch Nerlynx in September, RBC Capital Markets analyst Matthew Eckler pointed out

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Medical device R&D spending expected to rise through 2018
July 27, 2017
By Neozene

An Emergo survey of medical device companies finds that a higher percentage of smaller firms plan to increase their research and design spending over the next year than mid- and large-sized firms. The survey of 543 medical device executives in North America, Europe and Asia revealed not only planned R&D spending differences between smaller respondents (those with 50 or fewer employees) and larger firms (those with 50 or more employees), but also different business priorities driving those R&D spending plans. Medical device R&D spending overall set to increase in 2018

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