HAI Solutions Receives FDA De Novo Grant for QIKCAP System: Pioneering UVC Technology for Microbial Reduction on Needleless IV Connectors

HAI Solutions, a leading innovator in ultraviolet (UVC) microbial reduction medical devices, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo classification for its ...
Healthline

The FDA Development and Approval Process for Medications and Medical Devices

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...
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 ...
Health Affairs

FDA Breakthrough Device Designation: Clinical Evidence And Medicare Payment Policies

The Food and Drug Administration (FDA) Breakthrough Devices Program was created by the Congress in the 21st Century Cures Act of 2016. The program is designed to accelerate the development, assessment ...
CBS News

The FDA calls them "recalls," yet the targeted medical devices often remain in use

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or death ...
MD&M East

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
Crain's Chicago Business

Durbin, Schakowsky take aim at medical device recalls

The Illinois lawmakers want an electronic format for medical device makers to quickly and transparently report recall ...
Star Tribune

As FDA slashes workforce, number of new medical devices reaching the public has fallen

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as recent layoffs have reportedly had ...