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 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.
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.
A platelet bioreactor was developed by researchers at Brigham and Women's Hospital.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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.
The FDA has cleared Expanding Orthopedics's FLXfit implant for spinal fusion surgery, the Israeli company announced July 21.
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.
Varian Medical Systems scored FDA 510(k) clearance for its soft tissue transponder for radiotherapy and radiosurgery treatments.
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.
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.