News

As Zika fears spread, Cerus nabs American Red Cross partnership for blood pathogen reduction

More than a year after Cerus gained FDA approval--now the American Red Cross has bought into its technology with a multi-year deal for its Intercept Blood System for pathogen reduction in platelets and plasma. It's responsible for about 40% of the U.S. blood products, delivering 1.1 million plasma and 780,000 platelet units last year to almost 2,600 hospitals and transfusion centers.

Smith & Nephew to sell OrthAlign precision alignment tech alongside its artificial knees

Usually in the news due to constant rumors of an impending takeover by Stryker, Smith & Nephew announced that it will distribute precision alignment surgery technology alongside its artificial knee implants under an agreement with Aliso Viejo, CA, start-up OrthAlign.

Medtronic treats first patient with its investigational graft for aortic aneurysm repair

Medtronic signaled its interest in abdominal aortic aneurysm repair last year with the $110 million acquisition of Aptus Endosystems and investment in Arsenal AAA in return for an option to acquire the company. Now Medtronic says the first patient was treated in its trial of the Valiant TAAA Stent Graft System for thoracoabdominal aortic aneurysm.

Illumina taps former Google exec to lead liquid biopsy spinoff

Illumina said last month that it was "actively recruiting" a CEO for its new liquid biopsy spinoff, GRAIL, looking for someone with an extensive tech background. Now the company has tapped a former Google exec for the role, charging its new leader with helping GRAIL develop a screening test for the early detection of cancer.

Novartis and Microsoft team up to develop intelligent camera system for MS

Novartis has been riding a med tech wave lately, launching new projects to create digital and patient-monitoring devices. In its latest move, the company is working with tech giant Microsoft to develop an intelligent camera system for multiple sclerosis (MS).

Indian hospitals pioneering use of 'eICUs' to combat doctor shortage

Indian doctors recently saved the life of a 30-year-old woman by instructing an unspecialized doctor about chest compressions over Internet-enabled video. The country's private hospital chains such as Fortis and Apollo plan to expand the number of so-called eICU beds by about 20% a year, from about 3,000 beds right now.

Startup raises $7M, adds execs for FDA-reviewed, antibacterial hospital scrubs

Orlando, FL-based Vestagen Technical Textiles has raised $7 million to back its antibacterial hospital garments that it hopes to get through the FDA. The cash is expected to enable the upstart to get to market with its Vestex antibacterial textile, which it said can reduce harmful contaminants on garments, thereby reducing the spread of pathogens.

FDA prepares for panel on Medtronic, St. Jude leadless pacemakers

Leadless pacemakers from Medtronic and St. Jude Medical performed well in clinical trials, setting the stage for an exciting race for FDA approval between the two bigwigs. In a sign that the finish line is getting closer, the FDA is convening the experts on its circulatory system devices advisory panel to discuss optimal regulation of the devices.

FDA nod for LifeWatch wireless, patch-based vital signs monitoring system

Swiss remote diagnostic monitoring company LifeWatch has secured a clearance from the FDA for its wireless, patch-based vital signs monitoring system. It's expected to be used first in medical facilities such as hospitals and nursing homes, but eventually the company expects to target the ambulatory care market as well.

BTG, Philips roll out first cancer embolic bead visible via real-time imaging

Until now, interventional radiologists and oncologists had no means to be certain that when embolic beads were placed into blood vessels at the precise, intended location or that they remained there over time. Now, partners BTG and Royal Philips have treated the first liver cancer patient with their recently approved LC Bead Lumi that is visible via imaging and can be used during an embolization procedure as well as afterward to monitor that the embolic beads remain in their intended location.

CMS backtracks, gives Boston Sci favorable reimbursement for its stroke-fighting Watchman

In a win for Boston Scientific, the Centers for Medicare & Medicaid Services backed off its proposal to contraindicate usage of the Watchman left atrial appendage closure device in warfarin patients as a condition for reimbursement under its Coverage with Evidence Development program.

Hospitals, CMS rail against update to FDA device safety reports amid duodenoscope pushback

Last month, senators pointed to problems with duodenoscopes linked to superbug outbreaks and partly blamed an outdated FDA reporting system for not adequately monitoring the devices' safety. The lawmakers want to give the system a facelift, but they could face obstacles from hospitals and Medicare officials who are railing against some of the proposed changes.

Sientra resumes U.S. sales of breast implants after Brazil manufacturing fallout

Sientra is turning over a new leaf. The company will start selling its breast implants again in the U.S. months after issues cropped up at its Brazilian contract manufacturer's plant, prompting it to suspend sales of its devices.

Struggling Unilife extends negotiating period with Amgen over partial takeover

Struggling injection device specialist Unilife said in an SEC filing that it needs an additional week to negotiate a deal with potential savior Amgen, which would involve the big biotech purchasing up to 19.9% of the company's stock in return for a much-needed cash infusion. If the grand alliance pans out, Amgen would also gain preferred right of access to new delivery platforms and enter a manufacturing arrangement with Unilife.

IBM's Watson Health testing image analysis software

IBM is scrambling to add software that can analyze radiological images to its Watson Health unit.

St. Jude launches portable, intravascular cardiac imaging system in Europe, Japan

St. Jude Medical has launched a portable version in Europe and Japan of its system to offer physicians a view from within the heart to enable physicians to make decisions during catheter-based stenting procedures. Dubbed Optis Mobile, the system is expected to offer comparable imaging as compared to the company's already marketed Optis Integrated System.

FDA hits Dräger Medical with another Class I ventilator recall

Telford, PA's Dräger Medical warned customers that the alarm on more than 400 of its ventilators may inadvertently go off and cause the device to stop functioning. Dräger said that personal injury was not reported in any of those situations.

U.K.'s NHS commits $6B to digital health, making remote care a priority

The U.K.'s National Health Service hasn't exactly earned high marks so far for its efforts on the digital health front. Its prior efforts to convert to electronic medical records have failed. But the health program is redoubling its efforts now by committing £4.2 billion ($6 billion) to a variety of digital health initiatives. That news comes on the heels of the agency announcing a series of 7 med tech-focused trials with major technology partners including Alphabet's Verily, Royal Philips and Accenture.

Israeli startup reels in $6M for cartridge-based hernia repair device

Israel's Via Surgical brought in $6 million to develop its cartridge-based hernia repair device, a feather in the company's cap more than a year after its product got an FDA greenlight.

U.K. engineering company Halma purchases maker of real-time hospital monitors for $140M

The U.K.'s Halma became the latest company to diversify into med tech with the announcement that it has purchased Newton, PA healthcare sensor company CenTrak for £95.9 million ($140 million). It's the engineering company's second device deal in recent months, as it seeks to bulk up it is medical business, which provides about a quarter of the company's £726.1 million ($1 billion) in 2015 annual revenue.