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US FDA expands UDI training resources for medical device companies
By Stewart Eisenhart, Emergo Group The US Food and Drug Administration has published five new training and education modules on the online platform for the agency’s Unique Device Identification (UDI)...
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Retina Implant wins CE Mark for next-gen blindness implant
Retina Implant said today that it won CE Mark approval in the European Union for the latest iteration of its subretinal implant for patients blinded by retinitis pigmentosa. The Alpha AMS is the...
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Ex-AMO CEO Mazzo wants stay in insider trading case pending Supreme Court...
James Mazzo, the former Advanced Medical Optics CEO who was indicted 2 years ago, wants a federal judge to agree to a stay pending a U.S. Supreme Court decision this fall over issues he claims could...
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Court approves Nuo Therapeutics bankruptcy plan
Wound care company Nuo Therapeutics (OTC:NUOT) said yesterday that a federal court in Delaware approved a bankruptcy plan that would either see it continue as an independent company or become 95% owned...
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Sensus Healthcare postpones IPO
Sensus Healthcare reportedly postponed its initial public offering today, after setting terms earlier this month with a midpoint raise of $20 million. Boca Raton, Fla.-based Sensus makes the SRT-100...
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Medtronic launches Nuro overactive bladder treatment
Medtronic (NYSE:MDT) said today it launched its Nuro system designed for treating overactive bladder with symptoms of urinary urgency, urinary frequency and urge incontinence. The Fridley, Minn.-based...
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Quantel Medical wins $3m contract with India Defense Dept.
Ophthalmic device company Quantel Medical said today won a $3.4 million (EU €3 million) contract for ophthalmic laser equipment from India’s Ministry of Defense. Through the deal, signed by the...
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Neovasc gains on Q4, 2015 results
Neovasc (NSDQ:NVCN) shares are up today after the replacement heart valve maker posted its 4th-quarter and 2015 results yesterday, despite wider Q4 losses on a nearly -25% sales decline....
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Xtant Medical wins FDA nod for spinal laminoplasty system
Xtant Medical said today its X-Spine Systems subsidiary won FDA 510(k) clearance for its Xspan laminoplasty fixation system designed for use in the lower cervical and upper thoracic spine. Spinal...
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FDA clears LED Dental’s Tuxedo dental radiography device
LED Medical Diagnostics (TSX:LMD) said today its subsidiary LED Dental won FDA 510(k) clearance for its Tuxedo digital intraoral radiography system. The Atlanta, Ga.-based company’s Tuxedo imaging...
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FDA: Cook Medical central venous cath recall is Class I
The FDA today labeled Cook Medical‘s recall of its central venous catheter and pressure monitoring sets and trays as Class I over issues with tip splitting and separation. The devices being recalled...
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MassDevice.com +5 | The top 5 medtech stories for March 30, 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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Biotech investor Steve Burrill to pay $6m, banned from trading
Once-prominent biotech investor Stephen Burrill is barred from the securities industry and will pay nearly $6 million to settle SEC charges that he looted investment funds to cover losses in other...
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Precision Biopsy asks FDA to OK new ClariCore trial
Precision Biopsy said today it submitted an application to the FDA seeking a go-ahead to expand the trial of its ClariCore prostate biopsy system into a new Transrectal Ultrasound and MR/Fusion arm....
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Newly developed exoskeleton mimics human knee
Mechanical engineers from ETH Zurich have developed a prototype exoskeleton, the VariLeg, which they say more accurately mimics natural knee gait to give it an advantage on uneven terrain. The newly...
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AcuFocus raises $4m debt round
AcuFocus, which makes the Kamra eye inlay for treating nearsightedness, said it raised nearly $4.1 million in a round of debt funding. Irvine, Calif.-based AcuFocus said in a regulatory filing that the...
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An Infographic: Comparing Drugs & Devices Trials
Several years ago, IMARC Research published a whitepaper outlining the differences between Drug and Medical Device clinical trials. Since IMARC focuses primarily on medical device trials, we felt it...
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Priorities – Teamwork to achieve common goals
By: Robert M. Califf, M.D. With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work...
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Medtronic wins expanded indication for Pillcam Colon 2
Medtronic (NYSE:MDT) said today that the FDA granted an expanded indication for the Pillcam Colon 2 device it acquired along with Covidien last year. The new indication covers the detection of colon...
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He sold his first startup to Medtronic. Now he’s developing an even better...
Welcome to the Medsider interview series, a special new feature at MassDevice, which will appear regularly. All interviews are conducted by Scott Nelson, Founder of Medsider and Partnership Lead at...
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