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FDA OKs epilepsy trial for MDT’s Visualase MRI-guided laser
Medtronic (NYSE:MDT) said today that the FDA granted an investigational device exemption for a clinical trial of its Visualase ablation device in treating temporal lobe epilepsy. Fridley, Minn.-based...
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DJO Global, ex-Stryker reps want poaching case tossed
DJO Global and a quintet of ex-Stryker (NYSE:SYK) sales reps want federal judge to toss Stryker’s lawsuit claiming that DJO and the reps gutted its Indiana sales territory and are looking to lure more...
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Solera Health raises $4m for diabetes platform
Solera Health today said it raised a $4.1 million Series A1 round for its preventive health platform for diabetes. Prior backers BlueCross BlueShield Venture Partners and Sandbox Industries were joined...
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EndoGastric Solutions wins nod from medical society for Esophyx anti-GERD device
The American Gastroenterological Assn. recommended that insurers cover the Esophyx device for treating gastroesophageal reflux disease made by EndoGastric Solutions. Citing the data from a quartet of...
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Strong earnings help Consort Medical recover from hit by delay in Mylan approval
Consort Medical (LON:CSRT) said the impending launch of a generic Advair inhaler by Mylan (NSDQ:MYL) represents a significant opportunity for its Bespak drug delivery device unit, but analysts were...
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Si-Bone raises $20m for iFuse spine implant
Si-Bone said today that it raised a $20 million funding round, hot on the heels of the regulatory and reimbursement wins it logged this week. Nine unnamed investors participated in the equity round,...
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Viveve closes $16m uplisting
Viveve (NSDQ:VIVE) said today that its uplisting to the NASDAQ exchange grossed $15.5 million, including an unwriters over-allotment. Sunnyvale, Calif.-based Viveve, which makes a non-surgical...
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MassDevice.com +5 | The top 5 medtech stories for June 17, 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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Belgian hospital puts a little Pepper on it with robotic patient greeter
(Reuters) — A Belgian hospital has just welcomed its newest staff member: Pepper, a humanoid robot that speaks 19 languages. Developed to improve social and health care by the Belgian company Zora...
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AtriCure preps $150m offering
AtriCure (NSDQ:ATRC) registered for a securities offering worth $150 million that could bring in another $115 million for some of its stockholders in a secondary offering. West Chester, Ohio-based...
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New draft European medical device regulations published
By Stewart Eisenhart & Ronald Boumans, Emergo Group Emergo consultants in Europe and the US are performing a comprehensive evaluation of the new Medical Device Regulations (MDR) and In...
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UPDATE: FDA allows emergency use of Hologic’s Aptima, Procleix test for the...
Hologic (NSDQ:HOLX) said it won an emergency use exemption from the FDA for its Aptima diagnostic to detect Zika virus and for it and Grifols (NSDQ:GRFS) Procleix Zika screening assay under the FDA’s...
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Cerus, Terumo land $48m in BARDA grants for anti-Zika push
Cerus (NSDQ: CERS) and Terumo Corp. (TYO:4543) won grants from a U.S. Health & Human Services Dept. agency worth a collective $48 million to study their respective devices for eliminating blood...
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CVRx raises $47m, with another $25m in the pipeline
CVRx raised $46.5 million and has another $25.1 million waiting in the wings once it achieves ” a certain milestone,” the company said in a regulatory filing last week. Seventeen unnamed investors...
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Mainstay Medical pulls in $34m for Reactiv8 neurostim device for chronic pain
Mainstay Medical (EPA:MSTY) said last week that it raised a $34 million (€30 million) equity round for its Reactiv8 neurostimulation device, including a $17 million (€15 million) contribution from...
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VA taps Underwriter’s Labs to secure medical devices
The Department of Veterans Affairs inked an agreement with testing and safety firm Underwriter’s Laboratories to help secure their connected medical devices from cyberattacks, according to a new report...
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Cardica rebrands as Dextera Surgical
Cardica (NSDQ:CRDC) said today it is rebranding under the name Dextera Surgical, shifting its Nasdaq ticker to the new symbol “DXTR,” effective this Wednesday. The company said its new name reflects...
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J&J’s Ethicon recalls Physiomesh flexible composite hernia mesh
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last month recalled 1 of its surgical mesh products after studies showed higher revision rates after a type of minimally invasive hernia repair using...
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enLabel to hold interactive panel discussion at the fourth annual Medical...
enLabel Global Services is the first-time Bronze Sponsor of the Fourth Annual Medical Device Global Labeling Strategies Conference, hosted by Marcus Evans, on August 9 to 11, in Minneapolis. The...
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Axonics launches post-market sacral neuromod OAB study
Axonics Modulation Technologies said today it launched the Relax-OAB 65-patient post-market clinical follow-up study of its SNM system designed to treat overactive bladder. The SNM rechargeable...
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