News

Nanoparticles point to cancerous tumors in MRIs

Researchers are hoping to get into the clinic in the next three to 5 years with a self-assembling nanoparticle that targets tumors. The idea behind the technology is to make cancer cells more identifiable when using magnetic resonance imaging screening.

Edwards Lifesciences CEO asks Congress for better device regulation

Edwards Lifesciences CEO Mike Mussallem advocated for a more efficient regulatory and reimbursement system for medical devices before the congressional House Committee on Energy and Commerce yesterday July 22, pointing out that the U.S. was the 42nd country to approve the Irvine, CA-based company's Sapien artificial heart valve for frail, high-risk patients.

Melanoma Dx company Mela Sciences raises $27M

Investors are charging to the rescue of melanoma diagnostic device company Mela Sciences. Just a few weeks ago, company shares languished below the $1 minimum NASDAQ share price.

Device to create human platelets could transform transfusion

A platelet bioreactor was developed by researchers at Brigham and Women's Hospital.

3-D printing grows to scale within industry

Companies could face significant cost and regulatory hurdles moving forward, but many devicemakers and research outfits have already charted significant progress in 3-D printing. Here is an overview of recent corporate and clinical efforts in the field.

JAMA: Power morcellator devices increase levels of undetected cancers in women

Amid growing safety concerns over the use of power morcellator tools in gynecological procedures, new research shows that a significant number of women undergoing laparoscopic surgery with the device have increased levels of undetected cancer.

NeuroPace stimulator to be deployed in $40M DOD brain research initiative

The $40 million Department of Defense research program into restoring memory will use NeuroPace's implantable neurostimulator, a move that the company said could help it expand the product's indications beyond epilepsy.

Catheters for deep vein thrombosis may do more harm than good

Catheter-directed thrombolysis (CDT) has been used in an effort to reduce the incidence of post-thrombotic syndrome in deep vein thrombosis. But a newly published observational study suggests that not only is catheter use ineffective at preventing post-thrombotic syndrome, but it is actually associated with higher rates of adverse events.

Mobile medical app regulation will only get more challenging--and important

The FDA is trying to regulate mobile medical apps lightly, but will have a hard time doing so as they become more sophisticated. Consider a future of mobile blood pressure and blood glucose monitors.

St. Jude flexible cardiac catheter approved in EU, aims for FDA

St. Jude Medical is hoping to strengthen its franchise in ablation catheters--thin, flexible wires inserted non-surgically into the heart to treat cardiac arrhythmia. Its FlexAbility irrigated ablation catheter has garnered a CE Mark in Europe, where it has marketed the TactiCath contact-force sensing irrigated ablation catheter since 2012. The company hopes to get FDA approval by year end for both FlexAbility and TactiCath.

Google Glass app for dental surgery debuts

Dental implant company Avinent and mobile app company Droiders launched Avinent Glass earlier this month to provide real-time instructions to dentists as they perform tooth implantation surgery.

Smart bandage advances patient monitoring technology

Patient monitoring technology is a growing niche within the industry, with big and small operations looking for their cut of the profits. A new device from a team of nurses, engineers and computer scientists takes the trend one step further, monitoring a patient's health through a bandage.

Spinal fusion implants enter market amid growing skepticism from insurers

With more than 15 510(k)s cleared in 2014, spinal fusion devices rank among the leaders. But new entrants such as Titan Spine and Expanding Orthopedics are entering the market just as insurers are beginning to crack down on reimbursement for the invasive procedure that costs an average of $27,600 per hospital stay.

Intersect, Ocular ready to test the med tech IPO waters

A pair of med tech companies--Intersect ENT and Ocular Therapeutix--are on the road and ready for an IPO this week. Both of these companies have high-profile corporate investors, Medtronic and Baxter, respectively. They are trying to cash in on the recently renewed, public investor interest in life science IPOs to raise the money to market FDA-approved products and advance pipelines.

Profit stumble pushes Philips to focus on healthcare

Healthcare, the largest unit by revenue, was also the worst performing for Dutch electronics conglomerate Philips during the second quarter. The company said it is making moves to turn that around, including a management shake-up a few weeks ago for the group and the reopening of a medical imaging production facility in Cleveland, OH, during the third quarter.

FDA approves expandable implant for spinal fusion surgery

The FDA has cleared Expanding Orthopedics's FLXfit implant for spinal fusion surgery, the Israeli company announced July 21. 

Miss Idaho wears insulin pump in swimsuit competition

Miss Idaho is trending, but it has nothing to do with pageantry. The hashtag "show me your pump" became popular after newly crowned Sierra Sandison, diagnosed with Type I diabetes in 2012, was spotted on stage with her insulin pump by her side.

FDA clears Varian soft tissue transponder to treat cancer

Varian Medical Systems scored FDA 510(k) clearance for its soft tissue transponder for radiotherapy and radiosurgery treatments.

MIT device could give arthritics and others a helping hand with extra fingers

People suffering from limited dexterity in their hands may soon get an extra set of fingers to help navigate daily life with a device researchers at MIT have developed that is worn on the wrist and uses a unique algorithm to mimic human movement.

Patient groups argue for faster med tech FDA approvals at industry meeting

The president of the Society for Cardiovascular Angiography and founder of the Children with Diabetes Foundation made their case for faster approvals at a July 17 AdvaMed hearing in Washington, DC.