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 ...

Sign at the Food and Drug Administrations campus in Silver Spring, MD. Courtesy FDA Government regulation is supposed to make products safer. But new research shows that, at least for medical devices, ...

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 ...

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 ...

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 ...

Orthofix Medical Inc. OFIX announced its support for the continuation of the FDA’s Class III designation for Bone Growth Stimulators (BGS) devices through a press release dated Feb 24. It is pledging ...

The FDA’s two-day advisory hearing yielded recommendations for risk designation for a number of product types, such as plunger-like joint manipulators, which received a unanimous endorsement for a ...

AUSTIN, Texas — Back in the 1970s, a process created to help encourage innovation is now how 70 percent of medical devices get approved. “It's mind blowing. It’s just really upsetting,” said Frances ...

In the United States, medical device regulation and intellectual property (IP) protection are governed by complex statutory and regulatory frameworks that are distinct from—but closely related to, and ...

New devices that use artificial intelligence (AI) to diagnose skin cancer ― such as smartphone apps ― have been popping up over the past few years, but there is some concern over the accuracy of these ...