Spotlight On... FDA accepts 17, rejects 12 in first year of medical device Expedited Access Pathway; Medtronic opens new Asia-Pacific HQ in Singapore; CFDA approves Tissuemed surgical sealant; and more...

The FDA has made 29 decisions under its new Expedited Access Pathway Program for Medical Devices in its first year, the agency noted in a recent blog post. Of these, 17 were accepted with the remainder denied. These decisions were usually made in 30 days. The program is intended to facilitate faster access to novel technology for patients with serious diseases and unmet need. Products under the EAP program ultimately either go through Premarket Approval (PMA) or de novo review. "As the program has grown in the past year, we've  learned that companies who benefit most from this program are those that have a preliminary proof of principle for how their device works, but haven't undertaken formal studies to support future submissions to FDA. For these companies, discussing their Data Development Plan with the FDA and agreeing on a roadmap to their marketing application and beyond is an important part of a successful review," said Erin Cutts of the Office of Device Evaluation in FDA's Center for Devices and Radiological Health. More

> Medtronic ($MDT) has opened a new Asia-Pacific regional headquarters in Singapore to support its 80 locations in the region. More

> U.K.-based Tissuemed has nabbed an approval from the China Food and Drug Administration (CFDA) for its TissuePatch ultra-thin surgical sealant films, which is the first approval for a synthetic sealant by the agency. More

> The Mayo Clinic has partnered with Australian company ImpediMed ($IPD) to explore the use of its bioimpedance spectroscopy (BIS) technology to monitor fluid status and body composition in cardiology, nephrology, wellness and fitness. More

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