Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Writedown pushes Symmetry Medical into Q3 red
Symmetry Medical (NYSE:SMA) put some red ink into its ledgers during the 3rd quarter as it struggled to integrate a pair of acquisitions and recovered from a fire in a British plant that destroyed part of the facility.
Coloplast gains on Q4, FY2013 results
FzioMed wins independent review of Oxiplex gel
FzioMed said the FDA granted an independent review of its pre-market approval application for the Oxiplex spinal surgery gel.
San Luis Obispo, Calif.-based FzioMed originally filed its PMA application for Oxiplex in October 2007. The FDA responded with a "not approvable letter" back in July 2008 after determining that FzioMed hadn’t provided sufficient evidence of the gel’s effectiveness in aiding in healing following lower back spinal surgery.
TCT 2013: Is the Lutonix drug-coated balloon overblown? | MassDevice.com On Call
MassDevice.com +3 | The top 3 med-tech stories for Nov. 1, 2013
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
Boston Scientific closes $275M buyout of Bard’s electrophysiology unit
Insurer accuses Intuitive Surgical of hiding legal claims over da Vinci robot
Intuitive Surgical (NSDQ:ISRG) is facing a lawsuit from 1 of its insurers that alleges that the medical device company concealed legal claims filed over its da Vinci surgical robot.
Masimo beats The Street, raises outlook, shares slip anyway
Globus Medical gains on Q3 results, raised earnings guidance
Globus Medical (NYSE:GMED) shares gained this week after the medical device company reported strong 3rd-quarter results ahead of Wall Street’s expectations and raised its earnings outlook for the rest of the year.
Federal shutdown stalled 100 medical device submissions | MassDevice.com On Call
MASSDEVICE ON CALL — About 100 submissions to the FDA’s Center for Devices & Radiological Health languished during the 16-day shutdown of the federal government earlier this month, meaning it won’t meet its review goals, the agency told stakeholders.
Any submissions for 510(k) clearance or pre-market approval received between Oct. 1, when the shutdown began, and its end on Oct. 16 will be marked as received Oct. 17, Bloomberg BNA reported.