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Alere withdraws INRatio monitors from U.S. market
Alere (NYSE:ALR), in collaboration with the FDA, said today that it is voluntarily withdrawing its INRatio and INRatio 2 PT/INR monitoring systems designed to monitor blood flow and clotting. The...
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FDA clears Tandem Diabetes Care’s remote insulin pump updater
Tandem Diabetes Care (NSDQ:TNDM) said today that it won 510(k) clearance from the FDA for a wireless updater for its insulin pumps. San Diego-based Tandem, which makes the t:slim, t:slim G4 and t:flex...
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CMS: U.S. healthcare spending to rise 5.8% annually through 2025
(Reuters) — Healthcare spending in the U.S. will likely grow by an average 5.8% per year over the next decade, a bit faster than the past 2 years, due to an aging population, rising medical prices and...
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Tela Bio wins FDA nod for OviTex hernia repair bioscaffold
Surgical reconstruction company Tela Bio said yesterday it won FDA 510(k) clearance for its Ovitex portfolio of ventral hernia repair and abdominal wall construction reinforced bioscaffold products....
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Report: Average salary for medical device sales rep is $147k
Medical device sales reps are making on average $147,857 per year, according to a new survey report from MedReps.com, a solid $25,000 more than their counterparts in pharmaceuticals, who made the least...
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Stryker launches SonicAnchor extremity fixation anchor
Stryker (NYSE:SYK) said today that it’s launching a new fixation anchor for extremity repair surgeries, SonicAnchor, that’s designed to be liquefied by sonic energy and flow into cancellous bone....
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NovoCure wins FDA nod for next-gen Optune device
NovoCure (NSDQ:NVCR) said today it won FDA premarket approval for its 2nd-generation Optune system designed to treat glioblastoma patients. The Optune is a mobile device that delivers low-intensity,...
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FDA approves U.S. trial for Cohera Medical’s Sylys surgical sealant
Cohera Medical said this week that the FDA granted investigational device exemption for a clinical trial of its Sylys surgical sealant. Raleigh, N.C.-based Cohera said the Sylys sealant, which won...
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Bayer launches over-the-counter Aleve TENS pain device
Bayer (ETR:BAYN) said today it launched the Aleve direct therapy targeted transcutaneous electrical nerve stimulation pain relief device in the U.S. The device is designed as a non-invasive, drug-free...
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MassDevice.com +5 | The top 5 medtech stories for July 14, 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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BioCorRx launches R&D program for anti-addiction naltrexone drug-device combo
Anti-addiction developer BioCorRx said today it launched a research & development initiative as it seeks FDA approval for its naltrexone implant designed to treat opioid and alcohol addictions. The...
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Ximedica picks up Accel Biotech
Medtech developer Ximedica said today it acquired Los Gatos, Calif.-based medtech design firm Accel Biotech for an undisclosed amount. Get the rest of the story at our sister site, Medical Design &...
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Spirox wins FDA nod for Latera nasal implant
Spirox said today it won FDA 510(k) clearance for its Latera absorbable nasal implant designed to support upper and lower Lateral nasal cartilages to prevent nasal valve constriction or collapse. The...
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GE Healthcare, ThoughtWire ink 5-year deal to develop hospital apps
GE Healthcare Partners (NYSE:GE) said today it inked a 5-year collaboration agreement with Toronto-based software company ThoughtWire to develop digital tools for hospitals and health systems....
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Smart eyewear dev Vuzix raises $6.6m
Video eyewear and smart glass supplier Vuzix said today it closed a $6.6 million underwritten offering of common stock. The Rochester, N.Y.-based company said it sold 1 million shares of common stock...
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Survey: Medical device tax suspension boosts jobs, innovation
A survey of CEOs and board members at the Medical Imaging & Technology Alliance showed that the 2-year suspension of the medical device tax is resulting in increased hiring and more spending on...
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MEDDEV 2.7/1: A closer look at updated guidance on European clinical evaluations
By Ronald Boumans, Emergo Group Following the release of MEDDEV 2.7/1 with updated guidance on clinical evaluations in Europe, Emergo takes a deeper dive into some of the new version’s recommendations...
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Medicare gets back on board with unique device identifier
The Centers for Medicare & Medicaid Services is on board with plans to create a unique device identifier for implantable medical devices, after years of resistance from the federal health insurer....
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Report: Boston Scientific opens largest OUS R&D shop in India
Boston Scientific (NYSE:BSX) reportedly opened a new research & development facility in Gurgaon, India, today that is its largest R&D shop outside the U.S. The 100,000-square-foot center,...
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Ability Dynamics wins CE Marks for Rush foot prostheses
Ability Dynamics said yesterday that it won CE Mark approval in the European Union for its Rush line of foot prostheses. Tempe, Ariz.-based Ability Dynamics said its Rush Kid ultra-low-profile...
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