News

Ultrasound of the optic nerve can predict stroke severity, says doctor

In a presentation at the American Stroke Association's International Stroke Conference, Dr. Vishnumurthy Hedna said that conducting an optic ultrasound can help in the identification of stroke patients who are at imminent risk of dying.

New studies show that devices, not just drugs, can help treat strokes

Groundbreaking studies offer more evidence that revascularization devices that physically remove blood clots from the brain are a valuable and potentially lifesaving addition to pharmaceutical therapy in stroke patients.

Bayer starts reorg as it explores sale of diabetes devices biz

Rumors of a reorganization for Bayer are starting to firm up. It's underway and expected to be completed in 2016, according to a recent letter to employees that Bloomberg cited.

Invitae's $102M IPO stands alone as three med tech IPOs remain sidelined

Only one out of a potential of 5 med tech IPOs has gotten out this week, but it has done so with style. Invitae raised $102 million in an IPO that priced above its range and was upsized. It's a sign that life sciences investors remain picky amid a sea of med tech IPO offerings, as a number of neglected companies rush to the exits.

Sanofi backs Europe's first remote clinical trial--for a smart glucose monitor

A coalition of companies is participating in what is expected to be Europe's first clinical trial to be conducted remotely in full. The study is of a newly CE-marked blood glucose monitor from Finnish company Mendor.

Study: Tiny, insertable Medtronic cardiac monitor found more effective in AF detection

The latest clinical trial results for Medtronic's insertable cardiac monitor show that it's effective at detecting atrial fibrillation at an even higher rate than found in a previous study. That could help the company make its case for reimbursement for the smallest cardiac monitor available, the Reveal Linq, which was launched early last year.

AdvaMed unveils its 2015 Innovation Agenda, proposes automatic Medicare coverage of device clinical trials

AdvaMed CEO Stephen Ubl said the med tech innovation ecosystem is "fraying" at a news conference unveiling the trade association's 2015 Innovation Agenda to fix the ills of the industry.

Scientists unveil new biomarker for early detection of dementia through blood test

As scientists race to uncover ways to diagnose neurogenerative diseases in patients, Danish researchers have pinpointed a new biomarker that could predict an individual's risk of for dementia through a blood test.

NIH proposes a large-scale collaborative research effort into nondrug pain management

The National Center for Complementary and Integrative Health at the National Institutes of Health (NIH) has proposed conducting large research studies of nondrug pain management approaches. It did so in a report by a working group of the Center's Advisory Council.

Intraocular lens maker Staar Surgical gets warning letter over its manufacturing practices

Intraocular lens maker Staar Surgical was hit by an FDA warning letter over compliance with Good Manufacturing Practices at its plant in Monrovia, CA. The company says that on Feb. 4 the FDA issued a Form 483 warning letter with 10 observations.

J&J's DePuy Synthes adds to orthopedics strength with arthroscopic visualization startup buy

DePuy Synthes will introduce imaging for minimally invasive arthroscopic surgeries with the purchase of Utah-based startup Olive Medical for an undisclosed amount. Orthopedics is one of its stronger medical device businesses and this Johnson & Johnson company is focused on leveraging its scale across it.

Med tech venture firm BioVentures raising $100M fourth fund

BioVentures Investors has raised almost $20 million of a new $100 million fund, according to a regulatory filing with the SEC. If it's successful, that would almost double its amount under management, which was $133 million in three funds prior to recent fundraising.

Investors set sail toward China's rapidly growing device market

Amid rapid growth in China's medical device sector, investors are looking to cash in on the market with a string of M&A deals.

Welch Allyn partners with Spok to provide mobile alerts for its vital signs monitors

Patient monitoring player Welch Allyn has partnered with software company Spok to connect its vital signs monitors to the mobile devices of healthcare practitioners. The idea of a systemwide connection approach is to better prioritize and not overwhelm staff with device-related alarms.

Third Rock's NinePoint Medical gets $15M in debt for novel imaging

NinePoint Medical has raised $15 million in debt to support the marketing of its endoscopic volumetric imaging system of the esophagus. The financing comes almost two years after the company launched its NvisionVLE Imaging System in the U.S.

Zimmer revises its regulatory submission in bid to get approval of Biomet acquisition

Zimmer revealed that it has submitted a revised package to the European Commission to get approval of its $13 billion purchase of Biomet. The revision makes changes from the package proposed in December based on feedback from the commission. The deadline for the commission's decision is May 26. Zimmer still expects the transaction to close by the end of the current quarter.

Endoscopes linked to spread of deadly drug-resistant bacteria in hospitals

In the latest incidence of the outbreak of infections stemming from unclean endoscopes, 8 patients in Philadelphia were recently infected with bacteria resistant to the antibiotics known as carbapenems, which kill up to half of those infected, the Philadelphia Inquirer reports.

Biosensors Japan's PhIII trial of drug eluting has enrolled patients

The last of 140 patients have been enrolled in a trial of Singapore-based Biosensors International's clinical trial of its drug-coated stent, BioFreedom, according to a news release. The trial is being conducted in Japan by Leaders Free Japan patients at high risk of bleeding.

St. Jude starts study of world's tiniest pediatric mechanical heart valve

St. Jude Medical is starting a trial for a device that it hopes will be the smallest FDA-approved pediatric mechanical heart valve. The device is only 15 mm in diameter; that's roughly equivalent to the length of a staple.

Check out these next-gen devices in the incubator pipeline

Med tech incubator Edison Nation Medical gave FierceMedicalDevices details about the medical devices in its pipeline that are in need of a licensing partner. They range from a simple wand for collecting urine specimens to an asthma inhaler that can be conformed to fit in your wallet.