• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Special Reports
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Resources
    • About MassDevice
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
    • In-Depth Coverage
    • Latest News
  • Attend DeviceTalks
    • Events
      • DeviceTalks Minnesota – May 4
      • DeviceTalks Boston – May 27–28
      • DeviceTalks West
      • DeviceTalks Tuesdays
    • DeviceTalks Podcast Network
      • DeviceTalks Weekly
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Advertise
  • Subscribe
Home » FDA clears Masimo Stork home baby monitoring system

FDA clears Masimo Stork home baby monitoring system

December 18, 2023 By Sean Whooley

Masimo Stork baby health monitor
The Stork boot on a baby next to an image of the components of Stork. [Image courtesy of Masimo]
The FDA today published a 510(k) premarket notification granting clearance to the Stork baby monitoring system from Masimo  (Nasdaq: MASI) .

Stork offers a continuous and accurate view of a baby’s health data. It leverages Masimo’s noninvasive neonate monitoring technologies.

Masimo’s smart home baby monitoring system officially received its clearance on Dec. 15. The company already began its U.S. rollout to major retailers in August, having kicked off its initial launch in May. BTIG analysts Marie Thibault and Sam Eiber say the company plans to ramp up to around 250 outlets by year-end. They expect approximately 1,000 by 2024.

According to the analysts, prices range from $249 to $549, depending on the bundle for the Stork system. They say Masimo projects a market opportunity for Stork at around $500 million, making it a “premium segment” in baby monitoring.

“We remain bullish on Stork since we believe this represents an adjacent market opportunity that is closest to [Masimo’s] strengths in healthcare technology,” the analysts wrote. “We wait for more details on the indications for use once it is published on the database. We do not make any changes to our model at this time.”

More about the Masimo Stork system

Masimo designed Stork with noninvasive sensing technology that tracks pulse rate, oxygen saturation (SpO2), and temperature. With 2K quad high-definition (QHD)-capable video, parents monitor their baby through a companion smartphone app.

Stork’s user-friendly interface allows parents to customize room condition alerts, view historical data and receive sensor status notifications. With hospital roots, Masimo safeguards sensitive data on Stork with its AES-256-bit encryption.

The Stork system comes in multiple configurations. The flagship Stork Vitals+ includes a boot with a sensor, video camera and mobile app. This ultra-soft, medical-grade silicone boot conforms gently to the baby’s foot and comes in three sizes. Stork’s high-resolution camera provides nighttime vision and two-way audio through the camera, plus room condition monitoring. All components connect to the app.

Masimo CEO Joe Kiani said of Stork in May 2023: “With Stork, our goal is to improve the parenting experience through a seamless, thoughtful integration of advanced and trusted health technologies that bring real data to parents.”

Filed Under: 510(k), Digital Health, Featured, Food & Drug Administration (FDA), Health Technology, News Well, Patient Monitoring, Pediatrics, Regulatory/Compliance, Software / IT Tagged With: FDA, Masimo

More recent news

  • Siemens Healthineers links with Novo to advance liver fibrosis blood test
  • GE HealthCare rolls out AI software for predicting care bottlenecks
  • Wandercraft’s self-balancing Eve exoskeleton begins US launch
  • Citi downgrades Boston Scientific as cyberattack recovery compounds competitive pressure
  • Autonomix taps former Medtronic FDA counsel head for board of directors

About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

Primary Sidebar

Cart

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >
MDO ad
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2026 · Arrowfly LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of Arrowfly.

Privacy Policy