The FDA just exposed a shocking truth that puts countless American babies at risk: most wearable monitors claiming to track infant vital signs are completely unregulated.

Story Snapshot

• Most baby vital sign monitors lack FDA clearance, raising serious safety concerns for American families
• Only two devices—Owlet Dream Sock and Masimo Stork—have met FDA standards for over-the-counter use
• FDA issued urgent safety warning in September 2025 against unauthorized infant monitoring devices
• Unregulated devices may provide false readings, creating dangerous situations for infants

Government Regulators Finally Sound the Alarm

The Food and Drug Administration issued a critical safety communication on September 16, 2025, warning American families against relying on unauthorized infant monitoring devices. This long-overdue alert exposes how regulatory agencies under previous administrations allowed a flood of unvetted baby monitors to enter the market without proper oversight. Parents who trusted these devices to protect their children were unknowingly gambling with their babies’ safety, relying on technology that never underwent rigorous testing for accuracy or reliability.

Why the FDA Is Warning Against Some Wearable Baby Monitors https://t.co/BNecF0Lfql

— Ray (@R4yt3d) September 18, 2025

Market Flooded With Unproven Technology

The baby monitor industry exploded over the past decade as tech companies rushed to capitalize on parental anxiety and the desire for peace of mind. Countless devices entered the marketplace claiming to track heart rate, oxygen saturation, and breathing patterns without submitting to FDA clearance processes. This regulatory vacuum allowed manufacturers to make bold health claims while bypassing the safety standards that protect American consumers from potentially harmful medical devices.

Only Two Devices Meet Federal Safety Standards

Among the dozens of baby monitors flooding store shelves, only the Owlet Dream Sock and Masimo Stork have achieved FDA clearance for over-the-counter use. Masimo received clearance for its Stork system in May 2024, followed by Owlet’s Dream Sock approval in September 2025. These devices underwent extensive clinical testing to prove their accuracy and safety before earning federal approval. Parents can verify device authorization status through FDA databases using specific product codes for infant monitoring equipment.

The stark contrast between regulated and unregulated devices highlights a critical consumer protection issue. While cleared devices must demonstrate clinical accuracy through rigorous testing, unauthorized monitors can make health claims without proving their reliability. This creates a dangerous situation where parents may receive false alarms or, worse, miss genuine medical emergencies due to inaccurate readings from unvetted technology.

Protecting American Families From Corporate Negligence

The proliferation of unauthorized baby monitors represents another example of corporate interests prioritizing profits over public safety. Parents deserve transparent information about device accuracy and regulatory status when making decisions that affect their children’s health and wellbeing.

The Trump administration’s focus on regulatory accountability offers hope for stronger oversight of consumer health technology. By demanding that manufacturers prove their devices work as advertised, federal agencies can protect American families from the false promises and potential dangers of unvetted medical technology targeting vulnerable populations like infants.

Sources:

Masimo Receives FDA Clearance for Stork Infant Monitoring System
Frequently Asked Questions on FDA Clearance and Why It Matters for Your Baby
FDA Warns About Over-the-Counter Blood Pressure and Infant Monitoring Devices
FDA Issues Safety Alert on Devices for Monitoring Infant Vital Signs