IRVINE, Calif. - Masimo (NASDAQ: NASDAQ:MASI), a prominent medical technology company, has announced the FDA clearance of its Stork™ baby monitoring system for over-the-counter (OTC) use.
The device, which can be used without a prescription, is designed for healthy infants from birth to 18 months and monitors vital signs such as oxygen saturation (SpO2), pulse rate (PR), and skin temperature, alerting caregivers with visual and audible alarms when readings fall outside of preset ranges.
The Stork system employs Masimo's Signal Extraction Technology® (SET®), which is also utilized in neonatal intensive care units (NICU) and has been credited with aiding in the reduction of neonatal blindness and improving congenital heart disease screening in newborns. The technology is estimated to monitor over 10 million babies annually in hospitals, including those in 9 of the top 10 U.S. hospitals.
The device, which includes a boot made from medical-grade silicone, houses the patented SET® sensor technology. It is designed to fit comfortably on an infant's foot and comes in three sizes to accommodate growth. Masimo Stork's design also features a camera capable of 2K Quad High-Definition (QHD) for streaming video, with future edge AI-based features planned, such as the detection of babies turning face down.
Available in two versions, the Stork Vitals+ bundle includes the camera, while the Stork Vitals bundle offers a hub that connects the sensor/boot to the Stork app, allowing audio monitoring without video. Both bundles monitor room conditions and are expected to be available for purchase online and in retail stores this summer.
Masimo emphasizes that Stork is not intended to replace professional medical advice or treatment and should be used to supplement a caregiver's decision-making process. The company is also updating the Masimo Stork App to include the new alarm features for all existing and new users.
This announcement coincides with Masimo's 35th anniversary and reflects the company's ongoing commitment to improving patient outcomes and reducing healthcare costs with its monitoring technologies, which span hospital, clinical, and consumer settings.
The information for this article is based on a press release statement from Masimo.
InvestingPro Insights
As Masimo (NASDAQ: MASI) celebrates its 35th anniversary with the launch of its Stork™ baby monitoring system, the company's financial health remains a key factor for investors. According to InvestingPro data, Masimo has a market capitalization of approximately $7.25 billion, with a high price-to-earnings (P/E) ratio of 90.23, reflecting investor confidence in the company's growth potential. This confidence is further underscored by the adjusted P/E ratio for the last twelve months as of Q4 2023, which stands at 80.39.
Despite a modest revenue growth of 0.6% in the last twelve months as of Q4 2023, the company has managed to maintain a gross profit margin of 49.0%, highlighting its ability to retain a significant portion of its sales as profit. Furthermore, the company's stock has experienced a substantial price uptick of 67.95% over the last six months, indicating strong market performance and investor interest.
Looking at InvestingPro Tips, Masimo is expected to grow its net income this year, which may be a driving factor behind the stock's recent price increase. Additionally, the company operates with a moderate level of debt and has liquid assets that exceed its short-term obligations, suggesting a stable financial position. It's worth noting that there are 13 additional InvestingPro Tips available for Masimo, which could provide investors with more detailed insights into the company's performance and potential risks.
For readers interested in a deeper financial analysis of Masimo, they can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro. These insights could be particularly valuable in assessing the company's prospects following the release of its new consumer-facing product.
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