PRNewswire/ - MolecuLight today announced that its MolecuLightDX(R) wound measurement has been qualified by the U.S. Food and Drug Administration (FDA) as a Medical Device Development Tool (MDDT). The ...
Strata Critical Medical, Inc. shifts to organ transplant logistics; Keystone Perfusion deal lifts share to 13% and margins.
The demand for high-precision, custom-made ceramic parts has increased as global industries, from semiconductors to medical ...
Brittany Trang takes a closer look at a constellation of health AI validation tools from Stanford researchers.
As an authorized MDSAP Auditing Organization and a designated EU Notified Body, DNV is permitted to conduct audits under both certification schemes. This dual authorization allows manufacturers to ...
The "Sterilization of Medical Devices Training Course (Apr 23rd - Apr 24th, 2026)" training has been added to ResearchAndMarkets.com's offering. Sterile devices are free of viable microorganisms and ...
SCHOTT Pharma has pre-validated its SCHOTT TOPPAC® ISO-standardized polymer cartridge for compatibility with SHL Medical’s Maggie® large-volume autoinjector platform. The collaboration delivers a ...
The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
The FDA has eliminated a key barrier to the use of real-world evidence in certain medical device applications. Under new guidance issued Dec. 15, the agency said it will accept real-world evidence ...
The Association of Personal Injury Lawyers (APIL) has renewed calls for a national register of medical devices to help prevent future health scandals such as the pelvic mesh crisis. The group said the ...
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