In a strategic move, Masimo has obtained FDA 510(k) clearance for its groundbreaking W1 medical watch, allowing for both over-the-counter (OTC) and prescription use. This expansion opens new avenues for the device’s utilization by adults in hospitals, clinics, long-term care facilities, and even at home.
The Masimo W1 integrates cutting-edge technology, merging the MW1-1 sensor, hardware, and software module for pulse oximetry into a single wearable. Featuring an optical sensor and electrocardiogram electrode pads, the watch detects physiological signals and processes them using Masimo’s proprietary signal processing algorithms. The result? High-resolution readings of SpO2, PR, perfusion index (Pi), and heart rate from an ECG, displayed in real-time on the watch’s touchscreen.
The FDA clearance comes at a crucial juncture, following an order from the US International Trade Commission (ITC) that could potentially ban Apple Watch imports. The ITC decision stems from a court ruling earlier in the year, affirming that Apple had infringed on Masimo’s rights in light-based technology for reading blood-oxygen levels. Masimo alleges that Apple incorporated its intellectual property into several Apple Watch models.
While the ban is pending a presidential review and potential appeals, the Biden Administration has 60 days to decide whether to veto the import ban based on policy concerns. Despite a historical rarity of presidential vetoes in such cases, Apple retains the right to appeal the ban in the US Court of Appeals for the Federal Circuit after the review period concludes.
Simultaneously, the healthcare community is grappling with concerns about the accuracy of pulse oximetry, particularly for individuals with darker skin tones. In a recent joint effort, 25 state attorney generals penned a letter to the FDA, urging swift action to address the inaccuracy of pulse oximeters when used on people with darker skin. The letter emphasized the continued sale of devices without clear warning labels or guidance, posing potential harm to individuals.
As Masimo celebrates its FDA clearance, the intersection of technological innovation, legal battles, and healthcare disparities takes center stage in the evolving landscape of wearable health technology.
