MyChesCo on MSN4d
FDA Unveils Key Updates on Rare Disease Advances, Food Safety, and Medical Innovations
The U.S. Food and Drug Administration (FDA) has released a series of announcements covering a wide range of initiatives and ...
Healthcare Dive24d
New FDA pulse oximetry guidelines could stall under Trump
The FDA’s draft guidance clarified requirements for pulse oximeters, increasing the number of recommended study participants from a minimum of 10 people to 150, and provided more specifics on ...
Hackaday12y
Pulse Oximeter Displays Blood Oxygen Levels On A PC
The theory behind a pulse oximeter relies on the fact that hemoglobin ... far below what a commercial pulseox meter would cost. FDA approval not included.
USA Today6d
FDA approves first at-home, over-the-counter test for STIs. But there's a catch.
The U.S. Food and Drug Administration (FDA) has approved the first-ever testing kit for sexually transmitted infections that can be taken at home without a prescription. But it's not for everyone.
pharmaphorum3y
FDA green lights Oxehealth vital signs monitoring software
UK digital health company Oxehealth has claimed FDA approval for software that can ... It works the same way as a pulse oximeter, which is widely used in healthcare but must be attached to a ...
Wane29d
MethodSense Helps Medical Device Companies Meet FDA’s Tougher Draft Guidance for Pulse Oximeters
New FDA Draft Guidance Raises the Bar on Pulse Oximeter Accuracy – MethodSense Leads the Way in Compliance, Clinical Validation, and Regulatory Strategy Manufacturers need to understand both the ...
Healio13d
Remote monitoring program predicts asthma exacerbations
A remote monitoring program predicted when patients with asthma would experience distress, according to a poster presented at ...