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 ...
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 ...
DUBLIN & STAMFORD, Conn.--(BUSINESS WIRE)--Novaerus, a WellAir company that delivers clean air solutions to help prevent the spread of infectious outbreaks, announced today that the U.S. Food and Drug ...
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 ...
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 ...
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 ...
MINNEAPOLIS--(BUSINESS WIRE)-- Nortech Systems Incorporated (Nasdaq: NSYS) (the "Company"), a leading provider of engineering and manufacturing solutions for complex electromedical and ...
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 ...