Healthcare Dive25d
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The FDA’s draft guidance clarified requirements for pulse oximeters, increasing the number of recommended study participants from a minimum of 10 people to 150, and provided more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 ...
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 ...
FDA approves first at-home test to diagnose three STIs in women
The U.S. Food and Drug Administration granted marketing authorization for the first home-based, nonprescription diagnostic ...
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.
Healio14d
Remote monitoring program predicts asthma exacerbations
A remote monitoring program predicted when patients with asthma would experience distress, according to a poster presented at ...
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MethodSense Helps Medical Device Companies Meet FDA’s Tougher Draft Guidance for Pulse Oximeters
New FDA Draft Guidance Raises the Bar on Pulse Oximeter Accuracy – MethodSense Leads the Way in Compliance, Clinical Validation, and Regulatory Strategy Manufacturers need to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 ...
Yahoo Finance25d
New FDA pulse oximetry guidelines could stall under Trump
Efforts to fix bias and accuracy problems with pulse oximeters have an uncertain future under the Trump administration. After years of concerns that pulse oximeters may provide less accurate ...