News

Wall Street, media approve of Stryker's multi-year buying spree

In response to Zimmer's $13.4 billion bid for Biomet, rumor has it that Stryker will snatch up the other relatively small orthopedics player, the U.K.'s Smith & Nephew.

Private equity firm backs Sonoma Orthopedic with $12M to get ankle implant to market

Chicago-based private equity group First Analysis expects its $12 million cash infusion into Sonoma Orthopedic Products will be sufficient for the startup to gain FDA clearance for a new ankle implant--as well as to launch it and start to scale up sales.

China eases restrictions on device imports, charting a win for the industry

As med tech companies set their sails toward China, a new trade agreement between the U.S. and Chinese governments looks to ease restrictions for imports, paving the way for greater expansion by U.S. devicemakers.

Sorin says newly cleared Memo 3D ReChord will improve mitral valve repair

Italy's Sorin Group says its just-cleared Memo 3D ReChord semirigid annuloplasty ring for mitral valve repair will simplify the procedure and enable surgeons to achieve reproducible results.

Small cap Cerus spikes on back-to-back Intercept approvals by FDA

Small cap Cerus has gained some serious ground on Wall Street after the FDA approved its Intercept Blood System for platelets just a few days after the agency approved it for plasma use. Investors are betting that with the risk of Ebola in the forefront of public consciousness that processors of blood products will use any technology they can to improve the safety of their supply. These approvals mark the first time the FDA has approved a system to inactivate pathogens in platelets or plasma.

FDA outlines UDI implementation plans for 2015

The FDA outlined its 2015 plans for Unique Device Identification. If successfully pulled off, the UDI system promises many benefits to companies and consumers, including improved device recalls and better evidence collection.

AliveCor aims for widespread consumer adoption with new tech, reduced price

AliveCor has reduced the price on its ECG monitor to $74.99 from $199; it's also now a third-generation device that is 50% thinner and 40% lighter.

Goldman Sachs among backers of China imaging, healthcare IT company to tune of $610M

China's Neusoft will receive $610 million from a variety of investors including Goldman Sachs to fund its medical imaging and healthcare IT ambitions.

FDA warns against inappropriate use of fetal ultrasound imaging and heartbeat monitoring

The FDA issued a warning against unnecessary and excessive fetal ultrasound imaging and heartbeat monitoring using Doppler heartbeat monitors, advising women not to receive or perform the procedures at home or for nonmedical reasons.

CardioDx raises $35M privately--continuing to avoid an IPO

This spring, CardioDx had readied itself again to make a run at an IPO. But it's opted to take another round of private investment instead. It has raised $35 million in equity from new investor Alberta Investment Management alongside existing investors.

Imaging specialist Varian to increase software focus with purchase of MeVis

Mobile medical apps are all the rage, but software is growing in importance in traditional medical devices too, as evidenced by Varian Medical Systems announcement that it will acquire Germany's MeVis Medical Solutions AG, a provider of software for cancer imaging.

Myriad Genetics stymied in BRCA breast cancer test patent battle

Myriad Genetics lost big in its fight to keep competing breast cancer DNA tests off the market, as a U.S. appeals court ruled that its patents are not eligible for legal protection.

Covidien, Stryker tout stroke study that used their stents

A comparative study found that treatment of stroke using stent thrombectomy devices manufactured by Covidien and Stryker is twice as effective as treatment using medication alone.

European diagnostics startups Protagen and 14M close venture rounds

A pair of European diagnostics companies have wrapped up venture financings. Autoimmune diagnostician Protagen had a first close of a €10 million ($12.5 million) financing, while cancer genomic diagnostics company, 14M Genomics, a spinout of the Wellcome Trust Sanger Institute, got £12.5 million ($19.6 million).

Philips shells out $1.2B for Volcano to gain ground in imaging therapy

Philips is shelling out $1.2 billion for San Diego devicemaker Volcano to gain ground in catheter-based imaging and beef up its offerings as it refocuses on its new healthcare business.

First pathogen-reduction system for plasma approved by FDA

Small cap Cerus gained more than 10% in early trading on Dec. 17 after the FDA approved its Intercept Blood System for plasma. This is the first pathogen-reduction system approved by the regulator to prepare plasma to reduce the risk of transfusion-transmitted infections.

Smartphone plug-in launched for diagnosing ear infections

Diagnosing ear infections from home has come in the form of a smartphone accessory. Cellscope Oto is a clip-on otoscope, the tool doctors use to peer into infected ears, that attaches to a smartphone so a video or photo of the ear can be sent to the doctor's office without the patient leaving home.

Infraredx to collaborate on cardiovascular imaging R&D with Mass General

Infraredx is collaborating with Massachusetts General Hospital and its coronary imaging researcher Dr. Gary Tearney in a bid to further research and develop combination technologies that provide information about patients' coronary disease.

Roche launches point-of-care, PCR molecular diagnostic system from $450M deal for iQuum

Roche has launched the Laboratory-in-a-tube technology it acquired when it bought iQuum in April for $275 million up front and up to $175 million in milestone payments. Roche is making the system available in the U.S. and Europe.

Ortho-Clinical rolls out acute kidney injury diagnostic in the U.S.

Ortho-Clinical Diagnostics announced that the NephroCheck diagnostic test for acute kidney injury is now available nationwide to hospitals, marking another step forward for the product that put developer Astute Medical among this year's Fierce 15 med tech companies.