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MassDevice.com +5 | The top 5 medtech stories for August 29, 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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UK’s NICE set to recommend Heartflow’s FFRct
The U.K.’s National Institute for Health and Care Excellence last Friday released guidance supporting HeartFlow‘s FFRct technology, which uses algorithms to generate 3D models of blood flows and can...
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Muddy Waters refutes St. Jude response, presses on security flaws
Short-seller Muddy Waters shot back at St. Jude Medical (NYSE:STJ) today in a continued dispute over alleged cybersecurity flaws in the company’s cardiac rhythm management devices, saying St. Jude’s...
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When medical device software changes warrant a new FDA 510(k)
By Stewart Eisenhart, Emergo Group US medical device market regulators have clarified their recommendations for when changes to software or firmware should prompt a manufacturer to file a new 510(k)...
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Bluegrass Vascular wins CE Mark for Surfacer vascular access device
Bluegrass Vascular Technologies said today that it won CE Mark approval in the European Union for its Surfacer vascular access device and plans a limited commercial launch in 7 countries there....
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St. Jude Medical: Alleged Merlin@home ‘crash’ is actually a security feature
St. Jude Medical (NYSE:STJ) today issued another strongly worded refutal of accusations made by a short-seller aiming to drive its share price down, denying the allegations and calling out Muddy...
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Carmat shares gain on pivotal trial launch
French artificial heart maker Carmat (FRA:CXT) said yesterday that it launched a pivotal trial of its bioprosthetic artificial heart, hoping to use the data to win CE Mark approval in the European...
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Vention Medical boosts footprint in Ireland
Vention Medical said today that it boosted its footprint on the Emerald Isle with the opening of a new facility on the National University of Ireland’s Galway campus. Get the full story at our sister...
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International Biomedical Devices closes $2.4m convertible debt round
Early-stage med device company International Biomedical Devices said today it closed a $2.35 million convertible debt funding round to support its flagship ApertureCTC precision capsulotomy system...
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Intralink-Spine touts early safety data for Réjuve cross-linking device
Spinal device developer Intralink-Spine today released 1-month clinical results from a trial of its Réjuve system, touting early reduction of lower back pain in its 4 safety study patients. Rejuve is...
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Researchers: Short-seller’s claims about St. Jude Medical devices have ‘major...
A short-seller’s report that cardiac rhythm management devices made by STJ are vulnerable to hackers has “major flaws” and doesn’t prove its allegations, according to researchers from the University of...
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FDA clears Siemens’ Somatom Drive CT scanner
Siemens (NYSE:SI) said yesterday it won FDA 510(k) clearance for its Somatom Drive computed tomography dual-source scanner. The newly-cleared Somatom Drive system is designed to include Straton MX...
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FDA: Data show no benefit for anti-microbial wound dressings
Data showing the benefit of adding anti-microbial compounds to wound dressings are scant, the FDA said in supporting documents ahead of an advisory panel meeting next year, calling the available...
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MassDevice.com +5 | The top 5 medtech stories for August 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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Gore launches DrySeal Flex introducer sheath
W.L. Gore & Associates said today it is launching its DrySeal Flex introducer sheath designed for use with its Gore Excluder iliac branch endoprosthesis device, which is used for the endovascular...
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Want to detect gluten on the go? There’s a device for that
(Reuters) – A California startup has developed a portable technology that will allow consumers to test their food for gluten on the go. “Even when you go out and see these labeled menu items, you are...
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FDA nod for Angel catheter triggers $3m tranche for Bio2 Medical
The 510(k) clearance Bio2 Medical won from the FDA in July for its Angel catheter triggered a 2nd, $3 million tranche from Oxford Finance last week, the company said yesterday. The Angel catheter is...
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Skip the drops, Glaucoma patients look to drug-eluting contact lens
Daily medicated eye drops are the first line of treatment for glaucoma, the leading cause of irreversible blindness. The drops relieve pressure in the eye, a significant risk factor for glaucoma. But...
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FDA releases June 2016 510(k) clearances
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD June 2016 TOTAL 510(k)s THIS PERIOD 258 TOTAL WITH SUMMARIES 235 TOTAL WITH STATEMENTS 23 DEVICE: ORAL BOND STEINER...
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PharmaJet inks pact with World Health Organization for polio vaccine
By Sarah Faulkner PharmaJet said yesterday that it inked a multi-year partnership as part of the World Health Organization’s effort to eradicate polio, using the Colorado-based company’s needle-free...
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