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FDA approves Nuvasive’s Reline system for Magec spine implants
NuVasive Inc. (NSDQ:NUVA) said today that it won 510(k) clearance from the FDA for the Reline posterior fixation system used with its Magec device for treating severe spinal deformities. The Reline...
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ViewRay wins CE mark for MRIdian Linac scanner
ViewRay (NSDQ:VRAY) said today it won CE Mark approval in the European Union for its MRIdian Linac next-gen linear accelerator-based MRI-guided radiation therapy system. The newly cleared MRIdian Linac...
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Keystone Heart touts TriGuard cerebral protection data in TAVR patients
Keystone Heart today released data from transcatheter aortic valve replacement patients treated with its TriGuard cerebral embolic protection device, touting a significant reduction in brain lesions....
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Bioventus launches Exogen ultrasound bone treatment in Saudi Arabia
Bioventus said today it launched the Exogen ultrasound bone healing system in Saudi Arabia. The Durham, N.C.-based company’s Exogen is designed to use low-intensity pulsed ultrasound to “help stimulate...
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FDA approves 6-month endpoint in trial of Bard’s Lutonix 014 drug-coated balloon
C.R. Bard (NYSE:BCR) said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix...
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European medical device regulatory news you may have missed
By Stewart Eisenhart, Emergo Group EMERGO SUMMARY OF KEY POINTS: We analyze draft Medical Device and IVD Regulations that will replace current Medical Device Directives in Europe over the coming years....
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FDA approves Bayer’s Kyleena IUD
Bayer (ETR:BAYN) said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years. The German company said the long-acting reversible...
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GE plans ‘lab-in-a-box’ complex in Ireland
GE (NYSE:GE) reportedly plans to build 4 prefabricated drug factories in Cork, Ireland. The U.S.-based company said yesterday that it plans to put $167 million (€150 million) into a biopharmaceutical...
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Titan Medical closes $8m offering
Titan Medical (TSE:TMD) said today that it raised nearly $7.9 million (C$10.25 million) via an overnight offering it plans to use to restart the development program for its Sport robot-assisted surgery...
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FDA approves clinical trial for QT Vascular’s Chocolate Touch DCB
QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon. The device won the CE Mark for treating peripheral...
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Medeon Biodesign wins FDA 510(k) for AbClose
Taiwanese medical device company Medeon Biodesign said yesterday that it won 510(k) clearance from the FDA for its AbClose laparoscopic port site closure device. The AbClose device is designed as a...
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Zimmer Biomet launches Vanguard total knee arthroscopy system
Zimmer Biomet (NYSE:ZBH) said today it launched the Vanguard individualized total knee arthroplasty implant system. Warsaw, Ind.-based Zimmer Biomet touted the knee as 1st-of-its-kind, featuring 2...
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FDA clears Life Spine’s Pro-Link Ti cervical spacer
Life Spine said today that it won 510(k) clearance from the FDA for its Pro-Link Ti cervical spacer. The Huntley, Ill.-based company said the product is slated for full release by the end of 2016,...
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GI-View wins FDA clearance for Aer-O-Scope disposable colonoscope
GI-View said today that its Aer-O-Scope colonoscopy device won 510(k) clearance from the FDA. The company’s flagship product is a disposable colonoscope with 2 channels for tools to take biopsies...
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Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements....
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MassDevice.com +5 | The top 5 medtech stories for September 20, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s...
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Medtronic puts $1m into National Patient Safety Foundation
The National Patient Safety Foundation’s think tank, the NPSF Lucian Leape Institute, said today it received a $1 million grant from Medtronic (NYSE:MDT) to support the institute’s goals of improving...
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Versa Ventures buys Syncardia out of bankruptcy
SynCardia Systems said today that it was acquired by affiliates of investment firm Versa Capital Management, with current president & CEO Michael Garippa set to keep the corner office. Tuscon-based...
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Theranica raises seed round for Nerivio Migra wearable migraine device
Newly-formed med device company Theranica Bio-Electronics said today it closed a seed financing round led by Dr. Shimon Eckhouse and joined by a group of angel investors. The company did not release...
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Thermo Fisher closes $4B buyout of electron microscopy firm FEI
Thermo Fisher (NYSE:TMO) said today that it closed the $4.2 billion acquisition of electron microscopy company FEI Co. for $107.5 per share in cash. FEI designs, manufactures and supports...
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