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Remote heart monitoring can help detect emergencies
(Reuters) – Instead of having heart monitors with noisy alarms near patients’ beds in the hospital, it might be better to have off-site technicians do the heart monitoring remotely, a recent study...
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Mazor Q2 tops The Street in EPS, falls short of rev
Mazor Robotics (NSDQ:MZOR) shares rose today after releasing 2nd quarter earnings that put the company above The Street’s expectations for earnings per share, but slightly behind on revenue. The...
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FDA warning letters: Findings for clinical investigators
Each year the Food and Drug Administration (FDA) releases metrics on the Bioresearch Monitoring (BIMO) Program. The purpose of the BIMO program is to inspect FDA-regulated clinical trials to ensure the...
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DexCom shares droop on Q2 release
Dexcom Inc. (NSDQ:DXCM) released its 2nd quarter earnings late yesterday, nailing Wall Street analysts expectations for revenue but missing on earnings per share by nearly double, seeing shares shrink...
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Wright Medical surges on Street-beating Q2
Wright Medical (NSDQ:WMGI) saw shares surge over 10% after releasing 2nd quarter earnings that topped the Street in earnings per share but were off on revenue. The Memphis, Tenn.-based company reported...
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Reva Medical looks to CE Mark for Fantom scaffold
Reva Medical (ASX:RVA) said today it completed its submission for CE Mark approval of its Fantom sirolimus-eluting bioresorbable coronary scaffold following the completion of a clinical data analysis...
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LivaNova posts beat-and-raise Q2
LivaNova (NSDQ:LIVN) today posted Street-beating 2nd quarter earnings, raising its guidance and seeing shares rise over 10%. The U.K.-based company reported profits of $9 million, or 18¢ per share, on...
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ReliantHeart wins CE Mark for aVAD left ventricular assist device
ReliantHeart said yesterday it won CE Mark approval in the European Union for its aVAD left ventricular assist device. The aVAD device is an axial flow LVAD that features remote monitoring and flow...
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Start-up iBeat raises $1.5m in seed round for heart monitor watch
Early-stage heart monitor developer iBeat said yesterday it raised $1.5 million in an oversubscribed seed funding to support its heart-monitoring smartwatch. The round was led by Maveron, Subtraction...
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Memory may someday benefit from electric therapy
(Reuters) – It may someday be possible to send weak currents of electricity through the scalp during sleep to help improve memory for motor tasks, researchers say. Results of a small study suggest that...
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Covalon wins $7.6m Saudi Arabian supply contract
Covalon Tech said today it won a $7.6 million 12-month supply contract with the Ministry of Health facilities in Saudi Arabia to supply the country with its ColActive Plus and ColActive Plus Ag wound...
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Fujifilm wins FDA nod for digital radiography suite
Fujifilm Medical Systems (TSE:4901) said today it won FDA 510(k) for its digital radiography FDR Visionary Suite and FDR Clinica X-ray components. The new Visionary Suite X-ray system is designed for...
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MassDevice.com +5 | The top 5 medtech stories for August 3, 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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Intersect ENT shares up on Q2 that topped rev, missed EPS
Intersect ENT (NSDQ:XENT) released 2nd quarter earnings late yesterday that topped the Street’s expectations for revenue but fell barely short on EPS, with shares ticking up at the news. The Menlo...
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Digital imaging software dev StatRad raises $13m
Digital imaging software developer StatRad said yesterday it raised $13 million through an equity investment from a strategic institutional partner. Funding from the investment is slated to go towards...
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Ocular Therapeutix updates on Dextenza NDA, hopeful for resubmission
Ocular Therapeutix (NSDQ:OCUL) said today it received a complete response letter from the FDA covering the New Drug Application for Dextenza and updating that the company is hopeful it can resubmit the...
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The unique voices of our patient representatives
By: Robert M. Califf, M.D., and Heidi C. Marchand, Pharm.D. We recently met with 21 inspirational patients and patient caregivers who have made the extraordinary commitment to become FDA patient...
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Insulet Q2 tops the street, lifts guidance
Insulet (NSDQ:PODD) posted Street-beating numbers for its 2nd quarter, topping revenue and earnings per share expectations and lifting its full year guidance. The Billerica, Mass.-based company...
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Masimo shares surge on beat-and-raise Q2
Masimo (NSDQ:MASI) today released 2nd quarter earnings that topped the street and send shares skyward in early morning trading. The Irvine, Calif.-based company reported profits of $30 million, or 57¢...
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BD lowers outlook on Q3 earnings post
Becton Dickinson & Co. (NYSE:BDX) today posted 3rd quarter earnings that topped Wall Street’s expectations and saw sales grow massively, but lowered its overall revenue outlook and saw shares...
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