Mitralign grabs $35M Series D cash to advance mitral valve repair device
Cardiac device company Mitralign attracted $35 million in new Series D financing. The Tewksbury, MA, company plans to use the investment infusion with its eyes toward European testing and commercial launch for its catheter-based mitral valve repair system.
Devicemaker CryoLife coughs up $17M-plus for Hemosphere
CryoLife ($CRY) will pay an initial $17 million in cash for Hemosphere so it can grab its HeRO graft to treat end-stage renal disease.
NeuroSigma buys patents that advance TFN stents
NSVascular, a subsidiary of NeuroSigma, has picked up a portfolio of patents that will help it develop its technology for more easily treating intracranial aneurysms.
OraSure's OTC HIV test obtains crucial FDA panel backing
There isn't an approved over-the-counter home HIV diagnostic test yet. But OraSure stepped even closer to that milestone on Tuesday, when the FDA's Blood Products Advisory Committee voted unanimously to recommend approving the company's product.
GE seeks worthy device, Dx startups for $250M investment fund; Boston Sci, Philips sign marketing deal;
Medtronic's Resolute Integrity stent gains CE mark for 7 new indications
Plenty of companies make drug-eluting stents now. And with that competitive environment in mind, Medtronic has taken an interesting track for one of its products in the space: Getting it approved for as many indications as possible.
St. Jude wins CE mark for hypertension treatment device
The race to launch new cardiac rhythm management devices continues. This time, St. Jude Medical ($STJ) is rolling out its EnligHTN renal denervation system in Europe, following CE mark approval.
Smith & Nephew CEO: Lack of innovation begats plunging industry margins
The medical device industry is boring. It doesn't innovate. And that, rather than government austerity, is why companies continue to face falling margins. Before you write that off as a conclusion coming from an outside consultant, consider that it comes from one of the industry's major figures: Smith & Nephew ($SNN) CEO Olivier Bohuon.
Boston Sci, Abbott gain European sign-off for stent products & services
With European regulatory approvals in hand, Boston Scientific (BSX) and Abbott ($ABT) are both debuting stents or stent-related treatment offerings overseas that illustrate how rigorous competition in the space continues to be.
Sonitus Medical lands $25 million Series D round for hearing device
Sonitus Medical pulled in $25 million in a Series D round of VC funding, money the company will put toward its in-the-mouth hearing device.
After quiet Q4, device recalls surge in 2012
Recalls of medical devices jumped 160% between the fourth quarter of 2011 and the first quarter of 2012, a not-entirely unexpected development after 2011's late-year tranquility.
Cancer Genetics' $48.6M IPO to fuel R&D plus marketing hires
Cancer Genetics will ramp up clinical trials plus expand its sales and marketing staff with an initial public offering the company envisions will haul in close to $49 million.
Genetic test can predict whether eye cancer will spread
Researchers at Washington University School of Medicine in St. Louis have developed a genetic test that can accurately determine whether eye cancer will spread.
U.K. government rebukes regulators over breast implant controversy
After months of fallout from news that thousands of women across Europe and around the world had received silicone breast implants made with substandard materials, the British government has concluded that regulation couldn't have prevented everything, but tighter scrutiny would have helped.
Regentis grabs $10M Series C for cartilage regeneration implant trials
Regentis Biomaterials, armed with $10 million in new venture funding, plans to use the cash to expand in Europe and fuel further clinical development of GelrinC biodegradable cartilage-regeneration implant.
FDA panel wants higher standard for obesity-treating devices
If the risk is higher, the reward should be, too. That's an FDA panel's opinion on anti-obesity devices seeking regulatory approval.
Consumer group wary of industry concessions in FDA user fee bill
Consumer advocates aren't happy about the 5-year user fee re-authorization bill for the device and drug industries, which is now moving rapidly through Congress. That's because the bill is giving industries a quicker pathway to FDA approval for certain products.
D. Medical eyes world stage for insulin infusion device
D. Medical is looking to take its insulin infusion set worldwide, inking a deal with South Korea's Twobiens to market the Spring universal infusion set around the globe.
Roche pursues companion diagnostic for schizophrenia drug; U-Systems' automated breast ultrasound deemed 'approvable';
Medtronic: CRT-Ds are a bargain
The Minnesota medical device giant released results of an economic analysis of the RAFT trial that showed the implant is a cost-effective way to treat patients with mildly symptomatic heart failure.
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