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Eurasian countries agree to harmonized medical device framework
By Stewart Eisenhart, Emergo Group An agreement to establish a harmonized regulatory system for medical devices across Russia and several former Soviet bloc countries has been signed, but few details...
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Senate removes roadblocks to vote on FDA nominee Califf
The U.S. Senate yesterday moved closer to confirming Dr. Robert Califf to lead the FDA, overriding opposition from several senators who had sought to block a vote on the issue. In a procedural move...
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TransMedics launches pivotal trial for OCS liver transplant system
TransMedics said today that it launched a pivotal study of its OCS Liver device, which is designed to keep donated human liver warm and perfused until transplantation. Andover, Mass.-based TransMedics...
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FDA approves Boston Scientific’s Acuity X4 quad leads
Boston Scientific (NYSE:BSX) said today that it won pre-market approval from the FDA for its Acuity X4 quadripolar leads for its cardiac resynchronization devices. The approval marks the 1st time the...
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Medtronic claims title to world’s 1st app-based remote monitoring for pacemakers
Medtronic (NYSE:MDT) said today that its Canadian subsidiary won approval there for the world’s 1st app-based remote monitor for pacemakers, the MyCareLink Smart system. The Health Canada nod allows...
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InVivo Therapeutics enrolls 6th patient in spinal scaffold trial
InVivo Therapeutics (NSDQ:NVIV) shares are up this morning on the spinal scaffold maker’s announcement that it enrolled the 6th patient in its Inspire pivotal clinical trial. The patient, who’s being...
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‘Stentrode’ could revolutionize thought-control tech
(Reuters) — Powered exoskeletons that allow the paralyzed to walk are at the forefront of medical technology. Now Australian scientists are set to revolutionize the field with an ambitious new project....
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Over-allotment brings Titan Medical offering to $12m
Titan Medical (CVE:TMD) said today an over-allotment option on its most recent offering added another $1.1 million (CDN $1.6 million) through the sale of an additional 1.7 million units at 65¢ (CDN...
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SpectraScience picks up optical imaging company Oncoscope
SpectraScience said today it acquired the assets of optical imaging system company Oncoscope for an undisclosed amount. Durham, N.C.-based Oncoscope developed a proprietary optical imaging system...
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MassDevice.com +3 | The top 3 medtech stories for February 23, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the...
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RTI launches Unison-C cervical implant
RTI Surgical said today it launched its Unison-C anterior cervical fixation system designed and indicated for stand-alone anterior cervical interbody fusion procedures for treating degenerative disc...
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Hologic touts 3D mammography study data
Hologic (NSDQ:HOLX) said today that a study of women screened for breast cancer over multiple years using its Genius 3D mammography system showed a significant drop in recalls. The findings, which...
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Coll Plant jumps on CE Mark win for wound filler
CollPlant said today it won CE Mark approval in the European Union for its Vergenix FG flowable gel intended to treat chronic and acute wounds. In response to the news, the company’s share price was up...
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J-Pac Medical offers dry room processing capabilities for assembly and...
J-Pac Medical announced its dry room processing capabilities for the packaging of environmentally-sensitive healthcare products. J-Pac’s dry room capabilities feature low humidity processing in Class 7...
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Iran, a new frontier for medical device companies?
By Emad Elmasry, Emergo Group The recent lifting of Iranian sanctions opens up a new market to medical device manufacturers, one of the largest markets in the Middle East. If you are considering a...
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NuVasive loses $42m sales poaching case
A federal jury in California slapped NuVasive Inc. (NSDQ:NUVA) with a $41.8 million judgment after finding that the spinal implant maker poached sales reps from 1 of its distributors. Madsen Medical,...
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Nico wins $15 million for BrainPath neurosurgery device
Nico Corp. said it raised $15 million of a hoped-for $18 million funding round, led by prior backers River Cities Capital Funds and the Rose-Hulman Institute of Technology, for its BrainPath...
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Bayer taps strategy head Baumann for CEO | Personnel Moves
Bayer (ETR:BAYN) named strategy chief Werner Baumann to replace Marijn Dekkers as CEO today, prompting some industry watchers to speculate that there’s more deal-making ahead for the German firm’s...
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Greatbatch board OKs Nuvectra neurostim spinout
Greatbatch (NYSE:GB) said today that its board of directors approved the spinout of its QiG Group, which is slated to become Nuvectra Corp. once the deal closes, expected March 7. One Nuvectra share is...
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Johnson & Johnson loses $72m talcum powder suit
(Reuters) — Johnson & Johnson (NYSE:JNJ) was ordered by a Missouri state jury to pay $72 million in damages to the family of a woman whose death from ovarian cancer was linked to her use of the...
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