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 ...
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 ...
Acsh.org

Recalling Medical Devices

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 ...
JD Supra

Recalled Medical Devices: How to Check If You Have One

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, it will be important to make sure you know what this ...
Machine Design

The Challenge of 3D Printing Medical Devices

One way to accelerate innovation in recent times has been to use 3D printing. This process lets designers work through more iterations faster to find improvements, while accelerating failure to ...
RAPS

Is your software a medical device?

Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, ...
JD Supra

Maximizing The Term Of Patent Protection For Medical Devices

Patent term extensions (PTE) are crucial for medical device innovators to recover patent life lost during lengthy FDA regulatory reviews. While more common in pharmaceuticals, recent cases show ...
Medical Device and Diagnostic Industry (MD+DI)

Cybersecurity Threats to Medical Devices: Navigating the Evolving Threat Landscape

The healthcare industry faces an unprecedented cybersecurity crisis as connected medical devices proliferate at an alarming ...
Healthcare IT News

Proposed CISA rule would require reporting for cyber incidents and ransom payments

The Department of Homeland Security's Cybersecurity and Infrastructure Security Agency is proposing a sweeping cyber incident reporting structure across 16 critical sectors, according to its notice of ...
Becker's Hospital Review

Unique device identifiers required for class II medical devices this fall

Starting in September, class II medical devices will be required to be equipped with a unique device identifier to be in compliance with UDI regulations. The U.S. Food and Drug Administration passed ...
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 ...