News

Abbott gets $20M from DOD to develop portable concussion test

Abbott Laboratories and the United States Department of Defense are collaborating to develop a test that can be used to assess potential concussions quickly in the field. Abbott's handheld diagnostic i-Stat System is already in use by the military; the test will be developed for use on it.

After Walgreens avoids inversion, will Medtronic modify its Covidien offer?

Speculation is building that Minneapolis-based Medtronic will modify its offer for Dublin-based Covidien.

China's top health authority calls for more homegrown med tech

Global med tech companies could soon face mounting competition in China, as the country's top health authority is calling for a new set of initiatives to promote homegrown products and jumpstart the domestic industry.

FDA targets off-label use of intranasal splint, with safety alert and Class I recall notice

The FDA continued its attack on Enhancement Medical LLC's Expression intranasal splint, designating the product's July recall as Class I.

Study: Heart rhythm telemetry implants improve patient outcomes

Patients implanted with heart rhythm devices that automatically send information about cardiac abnormalities to a telemonitoring center showed improved outcomes in heart failures and fewer deaths than those without the remote monitoring leads, according to a new study.

FDA approves ear inserts to reduce TMJ pain

The FDA has approved TMJ NextGeneration, custom ear canal inserts that increase the volume of the ear canal when the jaw is closed, thereby discouraging the user from clenching the jaw and the surrounding muscles.

First 3-D surgery recorded using Oculus Rift

The MOVEO foundation funded a project that turned a complete surgery into an Oculus Rift 3-D visual experience for the first time.

Top U.S. senator urges Hospira to abandon inversion plans

Amid growing regulatory action to crack down on corporate tax inversions, a top U.S. senator is urging Hospira to keep its operations at home and abandon plans to move abroad for taxpaying purposes.

Foundation Medicine teams with MD Anderson for new trial of cancer Dx

Foundation Medicine is teaming up with the MD Anderson Cancer Center in Texas for a new trial of the the Cambridge, MA-based company's molecular diagnostic cancer test that targets therapies matched to individual patients.

FDA launches pilot program for qualification of medical device development tools

Medical device evaluation can only be as effective as the tools used to conduct the evaluation. The FDA has begun seeking applications for the Medical Device Development Tools Pilot Program to validate and review such tools in preparation for a final guidance on the topic.

Researchers explore 'shape-shifting' material for facial reconstruction

New research hints at a step beyond 3D printing in making customized implants. Researchers are working on a new material that changes shape when heated and could be used to surgically fill gaps in bone.

Intel, Michael J. Fox Foundation start smartwatch study to track Parkinson's patients

A couple of major players are making moves to get wearable med tech a bit closer to reality. Intel has partnered with the Michael J. Fox Foundation to collect data via smartwatches on Parkinson's disease patients, tracking the progression of disease.

Wearable and 3D printing companies raise more than $63M on Kickstarter, Indiegogo

Wearable device companies have raised at least $38.5 million on crowdfunding sites Kickstarter and Indiegogo, and 3D printing companies at least $25.6 million, according to calculations by Matt Witheiler, general partner at Flybridge Capital Partners. The statistic includes more than 80 companies that have raised more than $100,000.

Medical device cybersecurity is bad. But who cares?

While medical device security against cyberattacks is low, some experts say the benefits of devices far outweigh the small possibility of serious attacks.

J&J freed from Stryker lawsuit, could face renewed battle with Medinol over stent patents

Like many medical device companies, Johnson & Johnson is waging patent battles on many fronts at once. Recently, two cases in which J&J was the defendant took interesting twists.

California devicemaker rakes in $15M for innovative transcarotid stent system

Silk Road Medical raked in $15 million in financing for its innovative transcarotid stent system, a device that provides a less-invasive approach to traditional stenting.

Sofinnova spinoff HealthQuest targets $110M, makes first investments

Sofinnova Ventures has created venture firm HealthQuest Capital. It's in the midst of raising up to $110 million and has started disclosing early investments. An official announcement about the new firm is coming soon.

Apple HealthKit data-sharing plans must overcome HIPAA privacy regs

Apple has discussed collaboration with several promiminent healthcare players as it prepares to roll out its HealthKit service, which is anticipated to be an element of the iPhone 6 that's planned for this fall. The players include Mount Sinai Hospital, the Cleveland Clinic, Johns Hopkins and electronic health records company Allscripts, according to Reuters.

Vascular closure player Cardiva gets $12.5M, J&J exec to commercialize

GE Capital has lent Cardiva Medical $12.5 million to ramp up commercialization. The company hopes that the firm's Healthcare Financial Services unit will aid its efforts by bringing to the table its own medical device experience. Cardiva markets vascular closure products for use after catheterization including Vascade and Catalyst.

FDA approves lung preservation device

Expectations are high for the recently FDA-approved, donated lung preservation device, XVIVO Perfusion System with STEEN Solution.