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Today's Issue of BioWorld MedTech

Friday, April 20, 2018

Featured Headlines

Sientra looks to regain market share following approval of PMA supplement

Santa Barbara, Calif.-based Sientra Inc. (NASDAQ: SIEN) scored a big win this week, with the company reporting after the market closed Wednesday that the FDA had approved a final process enhancement for a manufacturing facility. As a result, Sientra is poising to regain market share with its Opus-branded breast implant products and ending an ordeal spawned by an inspection of a contract manufacturer in Brazil. Sientra closed at $11.98 Thursday after closing at $11.05 the previous day.

Data for Heartmate 3 LVAD suggest the need for a study against transplants

ORLANDO, Fla. – Some devices are just the latest and best in class while others force clinicians to revisit long-held assumptions about the possibilities of a device type. This appears to be the case with an interim report of data from a study of the Heartmate 3 device, which not only handily bested the Heartmate II for freedom from disabling stroke at two years, but also prompted one observer to ask whether the time has come to try a left ventricular assist device against transplantation.

Radiologists say time has come to grapple with promise of AI, big data

The twin tools of artificial intelligence and big data have proven more cumbersome than anticipated to apply to several fields of endeavor, but a new article in the Journal of the American College of Radiology says radiologists – and by implication, device makers – must begin now to sort through the challenges presented by these instruments if diagnostic imaging is to become a 21st century science.

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