Nasdaq

AnPac Bio Class III Medical Device Passes Extensive NMPA Registration Tests and Will Start Clinical Trial in Q1, 2022

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 ...
Cure Today

Medical Devices Face Stricter Regulations

The Government Accountability Office recently chastised the FDA for not moving fast enough in implementing stricter regulationsin approving Class III medical devices. In January, the Government ...
Nasdaq

China’s NMPA Approved Starting of Registration Testing of AnPac Bio Class III Medical Device (For Lung Cancer Auxiliary Diagnosis Utility)

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 ...
News Medical

Medical Device Categories Explained

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 ...
JD Supra

Ninth Circuit limits Medical Device Amendment preemption of post-PMA tort claims

Medical Device Companies should be aware of a recent en banc ruling by the Court of Appeals for the Ninth Circuit that has the potential to increase litigation involving class III medical devices. In ...
Business Wire

Global Medical Device Contract Manufacturing Industry Research 2024-2029: Increasing Consolidation of OEMs and Contract Manufacturers & Growing Interest of Private Equity Firms ...

DUBLIN--(BUSINESS WIRE)--The "Global Medical Device Contract Manufacturing Market by Device Type (IVD, Cardiovascular, Drug Delivery (Autoinjectors, Infusion Device), Diabetes Care, Orthopedic, ...
JD Supra

California Appellate Court Upholds Federal Preemption of Negligent Undertaking Claim Under the Medical Device Amendments of 1976

Federal preemption can be a very powerful defense. For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of ...