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MassDevice.com +3 | The top 3 medtech stories for December 18, 2015
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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ReWalk Robotics rockets on VA deal
ReWalk Robotics (NSDQ:RWLK) said yesterday that the U.S. Department of Veterans Affairs issued a policy to evaluate, train and procure its personal exoskeleton systems for all qualifying veterans in...
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GSI Group buys OEM RFID maker SkyeTek for $2.6m
GSI Group today said it bought medical OEM RFID maker SkyeTek for $2.6m in cash. Skyetek produces HF and UHF RFID technologies for OEMS in the medical and advanced industrial markets, according to the...
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Beyond Fitbit: The quest to develop medical-grade wearables
(Reuters) – A new wave of wearable computing devices that detect and monitor serious diseases is moving from the laboratory to the market, potentially transforming the treatment of conditions ranging...
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Teaching your smartphone to detect benign heart murmurs
More than half of all heart murmur referrals to pediatric cardiologists are for a Still’s murmur — a benign murmur that naturally occurs in 50 to 90 percent of children and goes away by adolescence....
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Obama signs medical device tax pause into law
President Barack Obama last week signed into law an omnibus tax and spending bill that pauses the medical device tax for 2 years, hours after the U.S. Senate approved the $1.8 trillion measure on a...
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Toshiba, amid 7,000 layoffs, looks to sell stake in medical business
Toshiba (TYO:6502), amid a massive restructuring aimed at righting the ship after a $1.3 billion accounting scandal, said it’s looking for outside investors to buy a stake in its healthcare business...
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The Zombie Deal That Won’t Die II: Rumors of Stryker’s buyout of Smith &...
Rumors of the zombie deal that won’t die, Stryker‘s (NYSE:SYK) reported buyout of Smith & Nephew (NYSE:SNN), were resurrected last week after StreetInsider reported that Stryker tabled an $18...
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Late summer tailspin pushes 2015 IPOs to 6-year low
The market for initial public offerings went into a tailspin last summer, sending 2015 IPOs to a 6-year low, Renaissance Capital reported. There were 170 deals worth a collective $30 billion this year,...
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NanoLogix inks custom Dx deal with Big 3 medtech firm
NanoLogix said today it inked a deal with “1 of the world’s 3 largest medical device manufacturers” to customize its NanoLogix N-Assay, a modified ELISA diagnostic device. NanoLogix is a rapid...
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Canada clears Medtronic Evera MRI SureScan ICD
Medtronic (NYSE:MDT) said today it won license approval from Health Canada for its Evera MRI-compatible SureScan implantable cardioverter defibrillator system. The Evera MRI SureScan ICD is licensed...
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Report: FDA, medtech in bed on 21st Century Cures Act
The FDA and the medical device industry reportedly collaborated on drafting the 21st Century Cures Act before its passage in the U.S. House last summer, drawing criticism from consumer watchdogs and...
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Axonics pulls in $39m Series B for neurmod bladder control device
Axonics Modulation Technologies said today it raised $38.5 million in a Series B financing round for its sacral neurmodulation technology. Irvine, Calif.-based Axonics is developing a miniaturized...
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For AirXpanders, a switch from 510(k) to de novo was no big deal
Scott Dodson didn’t worry when the FDA requested a call. Dodson is CEO of AirXpanders, a Palo Alto, Calif.-based company that had made a 510(k) submission for its AeroForm tissue expander, a device...
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BiO2 Med miracle: Angel cath pivotal trial ends 1 year early
BiO2 Medical said today the pivotal clincial trial of its Angel catheter hit its target of 150 evaluable patients and has concluded a solid year earlier than anticipated. The Angel catheter is designed...
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MassDevice.com +3 | The top 3 medtech stories for December 21, 2015
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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Johnson & Johnson lose 1st Philly mesh case
A jury in Philadelphia ruled today that Johnson & Johnson (NYSE:JNJ) must pay $5.5 million in the 1st in a series of pelvic mesh lawsuits. The jury found J&J liable, based on the negligence of...
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Si-Bone touts midwest Medicare reimbursement win
Si-Bone said today it won a positive local coverage determination from Kentucky and Ohio Medicare administrative contractor CGS Administrators for its minimally invasive surgical sacroiliac iFuse...
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Hoya expands vision biz into Russian market
Hoya Corp. (TYO:7741) said today it is entering into the Russian market through the creation of Hoya Lens RUS LLC. The Japanese company said it sees “significant opportunities” in its Russian...
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FDA Enforcement: Protecting Consumers and Enhancing Public Confidence
By: Howard Sklamberg, J.D. and Michael R. Taylor, J.D. Under the Federal Food, Drug, and Cosmetic Act, companies producing food, including dietary supplement products, for American consumers have a...
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