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Ethicon, Touch Surgical debut surgeon training app
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon announced a strategic collaborative deal with healthcare tech platform developer Touch Surgery to develop a collaborative simulated surgical training...
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FDA clears Impact, U.S.’s 1st concussion management device
The FDA yesterday granted de novo clearance to Impact Applications for its ImPACT computerized neurocognitive concussion management tool, touting it as the 1st of its kind to win clearance from the...
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Bio2 Medical wins FDA clearance for embolism-snaring Angel catheter
BiO2 Medical said today it won FDA 510(k) clearance for its Angel Catheter designed for pulmonary embolism protection by trapping clinically significant pulmonary emboli. The Golden, Colo.-based...
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Japanese MHLW aligns ISO 13485:2016 with its own QMS requirements
By Stewart Eisenhart, Emergo Group Japan’s Ministry of Health, Labour and Welfare (MHLW) has published an administrative notice on how the new ISO 13485:2016 quality system standard for medical devices...
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Cigna adds reimbursement coverage for 3D breast scans
Cigna (NYSE:CI) said this week that it’s revising its coverage to include 3D mammography for routine breast cancer screening. The Bloomfield, Conn.-based health insurer only reimbursed for 3D breast...
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Medtronic’s Q1 earnings top expectations despite top-line slip
Fiscal 1st-quarter earnings for Medtronic (NYSE:MDT) beat Wall Street’s consensus forecast today, despite a -1.5% sales decline. The world’s largest pure-play medical device maker posted profits of...
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Baxter, Satellite Healthcare ink dialysis deal
Baxter (NYSE:BAX) and Satellite Healthcare said today that they inked a deal to bring Baxter’s dialysis products into Satellite’s 80-site renal care network. Satellite, a non-profit group, is the...
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Rivanna Medical pulls down $3m
Rivanna Medical, which makes an epidural needle guidance device, raised $3 million in an equity offering, according to a regulatory filing. Charlottesville, Va.-based Rivanna won 510(k) clearance from...
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Insightec touts near 50% tremor score improvement in pivotal Exablate Neuro...
Insightec today touted results from a pivotal study of its Exablate Neuro system, which met its primary endpoint with patients treated with the system reporting a 47% improvement in a composite tremor...
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Short-seller’s cybersecurity accusations push St. Jude Medical shares down
Allegations by a short-seller that nearly half of St. Jude Medical‘s (NYSE:STJ) cardiac rhythm management devices are extremely vulnerable to hackers sent the company’s stock down some 8% today in...
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Derma Sciences touts Medicare reimbursement win
Derma Sciences (NSDQ:DSCI) said yesterday that Medicare Administrative Contractor National Government Services will now consider the company’s Amnioexcel amniotic allograft membrane for coverage. The...
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Agfa HealthCare’s Q2 sales, earnings slide
Sales and earnings for Agfa HealthCare, the X-ray device and film arm of Belgian firm Agfa-Gevaert (EBR:AGFB), both slid during the 2nd quarter. Agfa HealthCare posted earnings before interest &...
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Gobiquity raises $6m for mobile pediatric eye-scanner
Mobile vision tech company Gobiquity said today it received a $6 million investment from InterWest Partners to close its Series B financing round. Funds from the round are slated to be used to support...
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Mylan cuts EpiPen price in half after criticism
By Sarah Faulkner Mylan (NSDQ:MYL) said today that it would reduce the out-of-pocket patient cost for its EpiPen product, after being widely criticized for raising the price nearly 500% since 2009....
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EarlyBird Venture Capital launches $135m medtech fund
Earlybird Venture Capital today announced the 1st closing of its Earlybird Health Tech Fund, which has a target size of between $112 million and $135 million (EU €110-120 million). Investors in the...
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MassDevice.com +5 | The top 5 medtech stories for August 25, 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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FDA warns on programmable syringe pumps
The FDA today released a safety communication warning of problems with lack of flow continuity when programmable syringe pumps are set to low flow rates. The federal watchdog released the safety notice...
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Report: Coloplast looks to expand in Minnesota
Coloplast (CPH:COLO B) is looking to expand its worker base in Minnesota, according to a new report from the Twin Cities Business Mag. The company, which acquired the urology business mentor Minnesota...
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Study: Drug-coated balloons beat plain balloon angioplasty in peripheral...
Drug-coated balloon treatments reduce the risk of target lesion revascularization in treating femoropopliteal artery disease by 67% when compared to plain balloon angioplasty procedures, according to a...
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Amedica wins expanded FDA indication for Valeo II spinal fusion devices
Amedica (NSDQ:AMDA) said yesterday it won expanded FDA clearance for additional sizes of its Valeo II lateral lumbar interbody fusion device. The Valeo II lateral lumbar fusion device is made out of...
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