Business Wire

Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance

SEATTLE--(BUSINESS WIRE)--Tasso, Inc., the leading provider of convenient, clinical-grade blood collection solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared its ...
Becker's Spine Review

Spine implants, tech earning FDA nods in 2025

Here are 40 spine devices and technologies earning FDA clearances in 2025. Note: This is not an exhaustive list. 1. SurGenTec earned FDA 510(k) clearance for its OsteoFlo HydroFiber to be used as a ...

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 ...

AVACEN Medical Products Now Available to the VA Health System

Expected to Be a Record Year AVACEN was founded by two military families. We have always helped our military community whenever possible. Our dream has continuously been to have an AVACEN device ...
Hosted on MSN

What is an FDA Class I recall and why is it the most urgent?

The U.S. Food and Drug Administration (FDA) is the primary federal agency responsible for safeguarding public health by ensuring the safety, efficacy, and security of a wide range of products, ...
FierceBiotech

GAO probe finds understaffed FDA putting some medical device recall work on the 'back burner'

The FDA’s oversight of medical device recalls continues to be plagued by staffing challenges—forcing some activities to be placed on the “back burner” and resulting in lengthy response times, ...
Medscape

FDA Class I Recall for Getinge Cardiohelp Emergency Drive

Getinge is recalling the Cardiohelp System emergency drive over concern that it can become stuck or hard to turn due to friction being generated in the handle attachment, according to a medical device ...
GlobalData on MSN

Nearly a third of FDA medical device adverse event reports filed late

Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug ...

ProMed Delivers Proven Expertise in Contract Medical Manufacturing for Medical Device and Pharma Companies

ProMed, a leading contract manufacturer specializing in medical-grade silicone and plastic components, provides comprehensive support for medical device, pharmaceutical, and combination drug-device ...