News

MassDevice4h
FDA says Q’Apel aspiration system recall is Class I following discontinuation
Q’Apel Medical announced that the FDA classified a voluntary recall of its 072 A System as Class I, the most serious kind.
JD Supra2d
Federal Court Vacates FDA's Final Rule on Laboratory-Developed Tests
On March 31, 2025, the Eastern District of Texas issued a decision in the case brought by the American Clinical Laboratory Association (ACLA) and ...
Hosted on MSN12d
As FDA slashes workforce, number of new medical devices reaching the public has fallen
Classifications for reported “de novo” medical devices ... “The reduction did not affect drug, medical device, or food ...
FDA Classifies Q’Apel Medical Inc.’s Worldwide Medical Device Recall and Discontinuation of its 072 Aspiration System (Hippo) as Class I
On April 7, 2025, the U.S. Food and Drug Administration (“FDA” or “the agency”), classified Q’Apel Medical, Inc.’s (“Q’Apel” or “the company”) voluntary recall of 1,617 units of its 072 Aspiration ...
Federal Court 'Vacates in Its Entirety' the FDA's Costly and Onerous Lab Test Rule
RFK Jr. should accept the ruling and instruct the agency to immediately halt all efforts to regulate laboratory-developed and ...
FDA Recalls Nearly 200,000 Cans of Green Beans for Potential Contamination
The U.S. Food and Drug Administration issued a Class II recall notice to take back 8,242 cases (197,808 cans) of Good & Gather Cut Green Beans distributed by Target3.
FierceBiotech25d
FDA's novel medical device clearances slow to a crawl
According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s ...
Hosted on MSN1y
FDA Slaps Embolization Device With Class I Recall After Deaths
The Obsidio Conformable Embolic recall related to an increased risk for bowel ischemia is the most serious kind, the FDA said on Wednesday ... A total of 1,594 devices in the U.S. are included ...
Pharmabiz2h
US FDA classifies Q’Apel Medical Inc.’s worldwide medical device recall and discontinuation of its 072 Aspiration System (Hippo) as Class I
Fremont, California Monday, April 21, 2025, 18:00 Hrs [IST] ...
Medical Xpress12d
As FDA slashes workforce, number of new medical devices reaching the public has fallen
Classifications for reported "de novo ... "The reduction did not affect drug, medical device, or food reviewers, nor impacted inspectors. The critical work will continue." One employee on ...