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Chris Newmarker

E.U. publishes final version of medical device regulations

February 23, 2017 By Chris Newmarker

Ronald Boumans, Emergo Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published, and will come to a formal vote by the European Council on March 7 and by the European Parliament on March 20. Following these votes, the MDR and IVDR are expected to be formally published in late […]

Filed Under: Featured, Regulatory/Compliance Tagged With: European Union, medtech

How Trelleborg is getting the most out of its acquisitions—including with combo devices

February 9, 2017 By Chris Newmarker

SSF Specialty Silicone Fabricators Trelleborg MD&M West

Heather Thompson, Senior Editor As is the case with many medical device industry suppliers, Trelleborg has engaged in a spate of acquisitions to better serve the growing needs of its OEM customers for drug-device combo products and more. Last year, Trelleborg, Sweden–based Trelleborg announced the acquisition of Tustin, California–based Specialty Silicone Fabricators. They’ve made three […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Mergers & Acquisitions Tagged With: MD&M West, medtech, Specialty Silicone Fabricators, Trelleborg

Medtech stories we missed: Feb. 3, 2017

February 3, 2017 By Chris Newmarker

flashlight MassDevice stories missed

From disappointing Getinge earnings to a $2.25 billion U.S. Defense Department contract for Cardinal Health to a host of 510(k) clearances, here are seven recent medtech stories that are still worth a mention. 1. Getinge disappoints on earnings—again Getinge stock took a nearly 10% tumble last week after releasing earnings that Reuters says lagged analyst […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), mHealth (Mobile Health) Tagged With: Biogen, Biolase, Bioverativ, Cambridge Cognition Holdings, Cardinal Health, Getinge, medtech, Precision Spine, U.S. Department of Defese, Zimmer Biomet

West Pharmaceutical Services introduces new drug delivery safety products

February 2, 2017 By Chris Newmarker

West Pharmaceutical LyoSeal drug delivery safety

West Pharmaceutical Services, an injectable drug administration technology provider, has introduced two new products meant to improve drug delivery safety. The LyoSeal cap is all-plastic and provides instant sealing for lyophilized drug products. West designed the LyoSeal to minimize risks involved with established lyophilization processes while maintaining the necessary sealing requirements. The NovaGuard SA Pro […]

Filed Under: Featured, Hospital Care, Pain Management Tagged With: drug delivery safety, West Pharmaceutical Services

University of Virginia has a smartphone-controlled artificial pancreas

January 3, 2017 By Chris Newmarker

University of Virginia artificial pancreas

Danielle Kirsh, MDO Assistant Editor University of Virginia researchers are making strides when it comes to developing an artificial pancreas that can be controlled using a smartphone. The FDA approved the UVA-developed artificial pancreas for testing in 2012, and UVA received a $3.4M grant from the National Institutes of Health in 2013. The device is currently […]

Filed Under: Diabetes

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