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 ...
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 ...
Please provide your email address to receive an email when new articles are posted on . The FDA granted class II 510(k) clearance to Sleepiz One+, a contactless remote patient monitoring device that ...
AccurECG is AccurKardia's FDA-cleared Class II software as a medical device (SaMD) platform for fully automated, near real-time ECG interpretation. AccurECG provides beat-by-beat analysis, ventricular ...
On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, ...
Singular Health Limited (ASX: SHG), a medical technology company focused on creating a seamless healthcare ecosystem by ...
MINNEAPOLIS--(BUSINESS WIRE)--Nortech Systems Incorporated (Nasdaq: NSYS) (the "Company"), a leading provider of engineering and manufacturing solutions for complex electromedical and ...
Singular Health strengthens US commercial strategy on being granted FDA 510(k) clearance for its imaging platform 3DICOM MD® ...