Once a medical device is brought to market, FDA surveillance of its safety continues. “To facilitate incremental improvements in safety and effectiveness, the FDA allows manufacturers to modify ...
PHILADELPHIA, Jan. 04, 2022 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a US and China-based biotechnology company focused on early cancer ...
The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...
SAN JOSE, Calif., Feb. 08, 2021 (GLOBE NEWSWIRE) -- AnPac Bio-Medical Science Co., Ltd. (“AnPac Bio,” the “Company” or “we”) (ANPC), a biotechnology company with operations in China and the United ...
When I was writing last month’s column about former CDRH engineer Leroy Hamilton’s down-the-rabbit-hole quest for a better Form FDA-3429 for guiding device classifications at CDRH, I had no way of ...
INDIANAPOLIS, April 27, 2023 /PRNewswire/ -- NICO Corporation, an Indianapolis-based pioneer and leader in minimally invasive neurosurgery, announced today it is among early companies to successfully ...
DUBLIN--(BUSINESS WIRE)--The "Global Medical Device Contract Manufacturing Market by Device Type (IVD, Cardiovascular, Drug Delivery (Autoinjectors, Infusion Device), Diabetes Care, Orthopedic, ...
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