The FDA's Gastroenterology & Urology Devices panel came down firmly against EDAP's Ablatherm system for treating low-risk, localized prostate cancer. The panel voted 9-0 on the device's effectiveness, 5-3 against its safety (with one abstention) and said the risks outweigh the benefits by a vote of 8-0 (with one abstention).
The FDA's General and Plastic Surgery Advisory Panel will meet Aug. 1 to consider the PMA application of Cohera Medical's TissuGlu surgical adhesive in large-flap surgical procedures such as abdominoplasty (tummy tuck surgery).
Medical students at Standford are joining the ranks of future surgeons learning how to use Google Glass as an operation tool.
Amid regulatory and industry backlash surrounding the use of laparoscopic surgical tools in gynecological procedures, Johnson & Johnson is pulling its related device from the global market.
Most devices are launched in Europe before arriving in the U.S., and cardiology devices are certainly no exception to the rule. Tough FDA premarket review standards, and the novelty of the technology, have turned the race to sell the first bioresorbable stent in the U.S. into a marathon.
Long cleared by the FDA, Zeltiq Aesthetics' fat-freezing CoolSculpting technology gained enough traction last quarter to catapult the company to a surprise profit. The company was so confident, it also raised its 2014 guidance.
Boston Scientific scored a victory in its ongoing transvaginal mesh saga, winning the first case to go to trial in Massachusetts state court.
Devices and software aren't a huge part of Hospira's revenues, but they do comprise the worst performing growth segment within the company. To help turn this around, the company announced a plan to streamline and update its device offerings in May 2013; it's now about halfway to the completion anticipated during the second half of 2015.
Edwards Lifesciences stock soared 10% this morning on the back of a strong quarter, highlighted by the $750 million upfront payment it received from Medtronic to settle a patent dispute over the companies' competing artificial valves aimed at patients too frail to undergo open heart surgery.
Spinal device specialist NuVasive said it's third in the spinal device market and is aiming now for second place along with more than $1 billion in annual revenue. Wall Street ate up that news, along with an earnings beat and raised guidance, and chased the stock up 10% in early trading on June 30.
A wearable device for measuring exposure to ultraviolet light and a "smart" Kegel exercise aid recently created pages on Kickstarter requesting funders, highlighting the use of crowdfunding to back edgy new devices.
Medical device manufacturers could soon be looking at additional expenses following proposed changes to the Physician Payment Sunshine Act.
Danish devicemaker Coloplast is forging ahead with plans to add jobs in the U.K. as part of a global strategy to boost numbers for its chronic care business.
Nobel Biocare has confirmed it is in early discussions with potential buyers, after a Bloomberg article reported a rumored sale. The report said the company has hired Goldman Sachs to broker a transaction.
Medical and surgical supplier Owens & Minor is getting squeezed by unexpectedly low margins on higher-than-expected revenues as its healthcare customer base consolidates.
With the rise of high-potential mobile health (mHealth) devices and apps, the FDA needs to add funding and tools towards regulation of the rapidly expanding industry, research experts wrote in the New England Journal of Medicine. While most mHealth devices have relatively low risk, monitoring devices that can affect core health is within FDA jurisdiction and authority.
In one of the largest venture capital financing of the year, Proteus Digital Health announced it raised $172 million in a Series G funding round from undisclosed institutional investors after completing a second closing.
French devicemaker EDAP TMS SA is facing FDA scrutiny for its robotic device for prostate cancer, as regulators questioned the product's safety and efficacy in a new report.
Complications of diabetes are more easily treated when they are found early. Researchers at National Taiwan University Hospital have developed a wearable optical device to detect diabetic autonomic neuropathy, a common diabetic complication, that could be better than existing detection methods.
Google isn't just searching the Internet. The company will soon search the insides of people's bodies for new biomarkers by collecting their urine, blood, saliva and tears as part of its Baseline Study initiative.