A report posted in FDA's MedSun database describes two heart pumps that were returned to the manufacturer for investigation.
The Utah Supreme Court will decide whether to apply to medical devices a key legal doctrine that protects manufacturers of technologically-advanced products from the unfair application of strict liability.
A recently published study links silicone breast implants with a handful of rare diseases, but an FDA expert points to flaws in the study and says it highlights the need for better postmarket evidence generation.
The company's technology has been hailed as the first major change in breast tissue expansion in almost 40 years.
Removing the CyPass Micro-Stent from the market is in patients' best interests, and is "the right thing to do," said Alcon's chief medical officer, after five-year data revealed a higher rate of cell loss compared to patients who had cataract surgery alone.
BAROnova has submitted a premarket approval application to FDA for an implantable device designed to treat obesity.
The FDA-cleared system customizes implants as well as surgical instruments to get the best fit for each patient.
The Austin, TX-based company has been awarded a grant for nearly $3 million from the Department of Defense to develop its drug-delivery device.
The EndoBarrier has faced numerous issues over the past few years and has even had its CE mark taken away and its first pivotal study in the U.S. halted.
Boston Scientific is buying Veniti, a firm that has developed a stent system for treating venous obstructive disease, in a deal worth up to $160 million.
FDA extended the indication for Cianna Medical's Scout reflector, allowing the device to be used to mark soft tissue sites including lymph nodes.
Some of medtech’s largest companies are working for approval in the TMVR space, which could one day rival or surpass TAVR.
The two technology groups will collaborate to expand SCHOTT’s hermetic packaging portfolio with an innovative new glass micro bonding technology that will create new possibilities for electronic implantable devices.
Abbott acquired Tendyne back in 2015, a year where there was significant M&A activity in the transcatheter mitral valve replacement space.