Manufacturers of the surgical mesh devices have not provided reasonable assurances of safety and effectiveness, according to the agency.
Strong evidence of proper cleaning and reprocessing that eliminates the spread of bacterial infections is still not there, and improvements are necessary, says Shuren.
Skin is the largest organ in the body and as such it is critical to the maintenance of our bodies.
The vulnerability of legacy devices and systems can threaten patient safety and data privacy. Learn how to face these issues head on at this upcoming event.
Domas to share her insights at the MedTech Intelligence Cybersecurity conference in June 4–5 in Boston.
Viant Medical’s Grand Rapids, MI facility was hit with violations from the Michigan Department of Environmental Quality.
Developing medical devices in general is costly, but there is funding available for companies that are willing to create products specifically for pediatrics.
Manufacturers Mentor and Sientra did not adequately comply with post-approval study requirements that look at the long-term safety and risks of silicone implants.
The center will start phasing in efficiencies on March 18.
Adhesives are ubiquitous. With virtually limitless applications, the retail stick-to skin market is a good choice for companies looking to expand their product offerings.