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

InnerScope Hearing Technologies (OTC: INND) Completes FDA Class II Medical Device Registration for its Hearing Aid Devices

InnerScope has completed the FDA Medical Device Registration for Class II Hearing Aid, Air Conduction with Wireless Technology, and is preparing for the Launch of its Latest in Direct-to-Consumer ...
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 ...
Becker's Hospital Review

Bacteria-resistant scrubs designated Class II medical device by FDA

Vestagen Protective Technologies, a developer of healthcare worker uniforms and scrubs, received FDA clearance as a Class II medical device for its Vestex apparel — the first daily-wear scrubs to ...
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 ...
JD Supra

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is ...
Nextgov

FDA Set to Issue Final Rule Classifying VR Therapy Device for Pain Relief

Get the latest federal technology news delivered to your inbox. The Food and Drug Administration is set to publish a final rule in the Federal Register on Friday that would formally classify a new ...
Business Insider

Uni-Bio Science Secures Approval for Recombinant Collagen Class II Medical Device and Launches 肌顏態®: Pioneering Entry into the High-Growth Medical Aesthetics Market

HONG KONG SAR - EQS Newswire - 2 December 2024 - UNI-Bio Science Group Limited (the "Company", together with its subsidiaries, the "Group") is pleased to announce two significant milestones that ...
AppleInsider

Apple job listing hints at work on Class II medical device

Apple is looking to hire a regulatory project manager that will help the company develop a Class II medical device or feature likely related to the Apple Watch or iPhone. The project manager will work ...
Nasdaq

Nortech Systems Suzhou Facility Certified to Produce Class II Medical Devices for Asia Market

MINNEAPOLIS--(BUSINESS WIRE)-- Nortech Systems Incorporated (Nasdaq: NSYS) (the "Company"), a leading provider of engineering and manufacturing solutions for complex electromedical and ...
Business Insider

InnerScope Hearing Technologies (OTC: INND) Completes FDA Class II Medical Device Registration for its Hearing Aid Devices

ROSEVILLE, Calif., March 3, 2021 /PRNewswire/ -- InnerScope Hearing Technologies Inc. (OTC: INND) ("InnerScope") announced today it has completed and updated the FDA Medical Device Registration for ...