All of the Big Three devicemakers have worked to get their pacemakers certified compatible with MRI scans, but it doesn't look like they'll need to undertake similar efforts to ensure their patients will be safe in a CT scan.
Researchers have found that CardioDx's genetic test for coronary artery disease could help physicians more accurately identify obstructive CAD in patients--and save insurance companies precious dollars.
Investors drove Foundation Medicine's stock up more than 10% during late morning trading on Feb. 26. What got them moving? They responded to news that the cancer diagnostic darling continued to grow revenue at a healthy clip as 2013 came to a close.
The FDA may have gone too far and violated federal law when it chose to monitor 6 scientists who made public their safety concerns about medical devices approved at the agency, a congressional investigation has concluded.
Qiagen has rolled out a new test for high-risk human papillomavirus in India designed to screen women in areas with limited healthcare infrastructure.
The head of an Indiana company specializing in pediatric orthopedic devices asserts that the 2.3% medical device industry tax is forcing him to freeze hiring and pull back on product development--criticism that could carry more mileage considering the perceived deficit of pediatric-friendly devices and medical equipment in the marketplace.
OrbusNeich has enrolled its first patient in a two-country proof-of-concept study for its innovative dual-therapy stent.
Seno Medical Instruments raised $34.6 million of a planned $39 million Series C equity funding round. The company will use the funds for a pivotal U.S. study of its breast cancer diagnostic device, and to obtain CE mark approval for the device in Europe, it said in a statement.
Cheetah Medical's diagnostic tech that helps measure blood flow has drawn in some investor love. The Newton, MA, company said it pulled in $9 million in new financing to help advance an international rollout.
French company Cereplas is facing a government-ordered breast implant recall in France because its products came off the production line after substandard sterilization procedures, and the crisis is already spreading to Australia.
A case involving a medical device company led to a U.S. Tax Court decision determining that whistle-blower awards must be taxed as ordinary income.
India moved one step closer to approving critical changes to laws governing its medical devices. In a regulatory push, the country's health ministry agreed to examine recommendations of the standing committee on a new amendments bill, the Indo Asian News Service reported.
Neuromodulation is one of those medical device industry segments that are poised for some major growth in the coming years, based on projections compiled by the research outfit EvaluateMedTech.
Quanttus pulled in a $19 million Series A funding round and plans to use the money to advance work on wearable clinical monitoring technology with development mojo from Apple and the Massachusetts Institute of Technology, among others.
There were few surprises in the quarterly earnings report issued by Volcano Monday evening. The San Diego devicemaker's ongoing turnaround effort cost it $14.5 million in the fourth quarter, part of a $20.5 million loss for the quarter and a $34.5 million loss for the year.
Boston's Constant Therapy is at work on a cloud-based iPad app for patients undergoing brain rehabilitation, and the startup has wrapped up its first funding round.
Massachusetts medical device IT specialist Capsule Tech is launching its SmartLinx line of integration systems designed to link medical devices with patient data in real time.
Neuromodulation devices have been key to Boston Scientific's years-long effort to reverse its lagging fortunes, and now the med tech giant has teamed up with two European nonprofits to promote its treatments for Parkinson's disease and dystonia.
Scientists use 3-D printing to construct everything from hearing aids to dental crowns. But Organovo Holdings wants to take 3-D printing one step further and create living tissue that could be used in testing and organ transplants, Bloomberg reported.
While bioresorbable stents are inching their way through the U.S. development process, a newly published German clinical trial involving the first product of its kind to hit the market reinforces the medical benefit of a device that dissolves back into the body when its task is complete.