Masimo W1™ Medical Watch Receives FDA 510(k) Clearance for Over-the-Counter and Prescription Use
Masimo Corporation (MASI)
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Source: Business Wire
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 W1 is the first FDA-cleared watch to provide continuous real-time oxygen saturation (SpO2) and pulse rate (PR) for OTC and Rx use. The FDA clearance expands the indications for the Masimo W1 in the U.S. as a medical device for use by adults in hospitals, clinics, long-term care facilities, and in the home. Developed to be comfortable and lifestyle-friendly, the Masimo W1 medical watch empowers users with untethered continuous pulse oximetry as they move about their lives – no matter where they are.This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231117805580/en/Masimo W1™ (Photo: Business Wire)The clinical power of the Masimo W1 comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates ov
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- Masimo (NASDAQ:MASI) had its price target raised by analysts at BTIG Research from $198.00 to $200.00. They now have a "buy" rating on the stock.MarketBeat
- Masimo Hosts 2025 Investor Day and Details Strategic Roadmap for Durable GrowthBusiness Wire
- Masimo (NASDAQ:MASI) had its "hold" rating reaffirmed by analysts at Needham & Company LLC.MarketBeat
MASI
Earnings
- 11/4/25 - Beat
MASI
Sec Filings
- 12/11/25 - Form 144
- 12/3/25 - Form 8-K
- 12/1/25 - Form 8-K
- MASI's page on the SEC website