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 ...
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 ...
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 ...
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 ...
Opternative, a Chicago-based purveyor of online and mobile refractive eye exams, received a warning letter from the FDA last fall. The October 30 warning letter was only recently made public by the ...
MINNEAPOLIS--(BUSINESS WIRE)--Nortech Systems Incorporated (Nasdaq: NSYS) (the "Company"), a leading provider of engineering and manufacturing solutions for complex electromedical and ...
According to the teased image, this smartwatch will feature a round dial with a sleek, non-bulky design and two physical buttons on the right side. The strap seems sturdy and is expected to include ...
WORK Medical’s subsidiary Hunan Saitumofei receives manufacturing approval for its Class II medical devices: Hangzhou, China Wednesday, December 31, 2025, 15:00 Hrs [IST] WORK M ...
Impakt Health RPM SaMD is Class II certified in Japan (PMDA), uniting telehealth, AI analytics, and blockchain integrity for secure, patient-centered care. Impakt Health RPM SaMD: hybrid cloud with ...
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