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 ...
AUSTIN, Texas, Feb. 8, 2023 /PRNewswire/ -- Recens, Inc. dba CoolHealth ("CoolHealth"), a venture-backed medical device company developing innovative cooling technologies, is entering the U.S. market ...
SAN FRANCISCO, Oct. 30, 2025 /PRNewswire/ -- Sirona Medical today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sirona Advanced Imaging Suite, marking ...
Turkey-based digital health startup h2o therapeutics announced its new Apple Watch-enabled freezing of gait-cuing feature, dubbed Foggy, designed for Parkinson’s Disease patients has received FDA ...
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 should replace its 35-year-old 510(k) clearance process for medical devices, says a new report issued by the Institute of Medicine. “The committee found that the ...
Results that may be inaccessible to you are currently showing.
Hide inaccessible results
Feedback