Business Wire

Masimo W1™ Medical Watch Receives FDA 510(k) Clearance for Over-the-Counter and Prescription Use

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced that the Masimo W1™ medical watch has received FDA 510(k) clearance for over-the-counter (OTC) and prescription use (Rx). Masimo ...
MobiHealthNews

FDA clears Masimo’s forehead sensor for pulse oximetry monitoring

Irvine, California-based Masimo Technologies, which makes non-invasive patient monitoring devices and sensors, has received FDA 510(k) clearance for its forehead sensor. The adhesive TFA-1 Forehead ...
FierceBiotech

Masimo wins de novo clearance to add oxygen reserve index calculations to pulse oximeters

When a patient is receiving supplemental oxygen during surgery, there’s a risk that they’ll develop hyperoxia, where their arterial blood becomes oxygenated above normal levels, potentially leading to ...
FierceBiotech

Masimo touts study showing its pulse oximeters are effective across skin tones regardless of perfusion levels

About a week after the FDA convened its latest meeting to discuss strategies for reducing racial biases in widely available pulse oximetry technology, Masimo has released new study data suggesting ...
AFP

Masimo SET® Pulse Oximetry Performed Accurately on Hospitalized Newborns of All Skin Tones in Largest-Ever Prospective Real-World Study

These promising results—from an NIH-funded study that exclusively evaluated Masimo SET ® in a vulnerable, clinically fragile patient population—add to previously published evidence of its strong ...