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FDA Cracks Down on Owlet for Monitoring Live Oxygen Saturation

In October 2021, the FDA issued a letter to Owlet cautioning that the features of its Smart Sock, particularly the oxygen monitoring capabilities, warrant its classification as a medical device. Oxygen-monitoring devices are intended to diagnose desaturation, a medical condition necessitating attention, as opposed to low heartbeat or bradycardia.

FDA-Warning-Letter-to-Owlet

FDA responded by pulling its products from retail outlets and set off to try to obtain FDA clearance. Part of that process led Owlet to start marketing Owlet as sleep quality indicator and not oxygen and heartbeat monitor.

2 years later in 2023, FDA gave Owlet De Novo clearance and it resumed the sale of its Dream Sock with new marketing lingo. It didn’t resume live tracking and push notifications for low oxygen levels until its full FDA clearance in November 2023.

It is important to note that FDA’s crackdwon on Owlet mostly resulted from its oxygen monitoring capabilities to detect low oxygen level. Low oxygen level is also called desaturation and happens when blood oxygen level (SpO2) falls below expected normal rate.

What sets desaturation from bradycardia?

Desaturation and bradycardia are two conditions that are often monitored in newborns and infants for signs of underlying health issues, but they are viewed differently in the context of medical diagnostics. Let’s delve into why desaturation is considered a diagnostic indicator of medical conditions, while bradycardia might not be viewed in the same light.

Desaturation

Desaturation refers to a decrease in the oxygen saturation levels in the blood. Oxygen saturation is a critical measure of how effectively oxygen is being transported to the organs and tissues of the body. A drop in oxygen saturation (desaturation) can indicate that the body is not receiving enough oxygen, which can lead to hypoxia (oxygen deficiency at the tissue level).

This can be caused by a variety of conditions, including respiratory distress syndrome, congenital heart defects, airway obstruction, and pulmonary diseases, among others.

Desaturation is a critical diagnostic indicator because persistent low oxygen levels can lead to significant and immediate harm to vital organs, especially the brain and heart, and may signify serious underlying health issues that require prompt medical intervention.

Bradycardia

Bradycardia is defined as a slower than normal heart rate. In newborns and infants, a certain level of bradycardia might be considered normal, especially during sleep. However, significant or symptomatic bradycardia can be concerning and may indicate underlying issues such as congenital heart problems, infections, or hypoxia.

While bradycardia can be a symptom of underlying health problems and warrants investigation, it is not always directly diagnostic of a specific condition. The interpretation of bradycardia as a medical issue often depends on the context, including the presence of other symptoms, the degree of bradycardia, and the overall health of the infant.

Why Desaturation is More Directly Diagnostic

The key difference in how desaturation and bradycardia are viewed in medical diagnostics lies in their direct impact and the immediacy of the threat they pose. Desaturation directly indicates a deficiency in oxygen delivery to the body, which can quickly lead to severe consequences if not corrected.

This makes it a critical diagnostic indicator that requires immediate response. Bradycardia, on the other hand, may be a sign of an underlying condition but does not immediately indicate the severity of oxygen deprivation or direct tissue harm, making its diagnostic interpretation more dependent on additional clinical context and findings.

In summary, desaturation is considered a more direct diagnostic indicator of medical conditions because it signifies a critical and immediate threat to oxygen delivery and tissue health, necessitating prompt medical attention.

Bradycardia, while potentially significant, requires further evaluation to understand its cause and implications fully, and its diagnostic value is often considered in conjunction with other clinical findings.

How Owlet’s FDA-cleared Oxygen Monitoring Works:

Owlet’s oxygen monitoring technology, specifically through the Dream Sock, operates on the principle of pulse oximetry, a non-invasive method used to estimate the oxygen saturation (SpO2) levels in the blood.

Oxygen saturation is a critical metric indicating how much oxygen the blood is carrying compared to its maximum capacity. For healthy infants, as well as adults, these levels typically remain above 90%, indicating adequate oxygenation of the body’s tissues and organs.

How Owlet Monitors Oxygen Saturation:

  1. Baseline Understanding: Once the Dream Sock is set up and paired with the Owlet Dream App, it’s important for caregivers to familiarize themselves with the baby’s typical oxygen saturation levels. This baseline understanding allows for a clearer detection of deviations that might indicate a problem.
  2. Continuous Monitoring: The Dream Sock continuously monitors the infant’s oxygen saturation levels, providing real-time data. This constant monitoring ensures that any significant drop in oxygen levels can be promptly detected, allowing for quick response to potential issues.
  3. Variability in Readings: It’s normal for oxygen saturation levels to vary slightly (within about 5%) from the infant’s baseline. Factors such as activity level and even high altitude can affect these readings. At high altitudes, for instance, it’s common for oxygen saturation levels to be slightly lower than what would be observed at sea level, though they should still remain above 90%.
  4. Alert System: The Dream Sock is designed to alert caregivers if the oxygen saturation level falls to 80% or below. This threshold is set because levels below 90% can indicate potential hypoxemia (low blood oxygen), and a drop to 80% or lower requires immediate attention. The alert system ensures that caregivers can take swift action, such as checking on the baby, adjusting the sock for a better reading, or seeking medical advice if necessary.
  5. Estimation of Blood Oxygen Saturation: It’s crucial to understand that readings from the Dream Sock should be used as estimates of blood oxygen saturation. While pulse oximetry is a reliable method for monitoring oxygen levels, the device provides an approximation rather than a precise measurement. This approximation is typically sufficient for home monitoring and deciding when further medical consultation might be needed.

Monitoring Desaturation and Bradycardia

Desaturation, or the drop in oxygen saturation levels, is a critical health metric because it can indicate several underlying conditions that require immediate attention.

The ability to monitor this parameter in real-time allows caregivers to respond quickly to potential health threats. Owlet’s technology, by providing live updates on oxygen levels, empowers parents and caregivers with information that was previously only available in clinical settings.

Bradycardia, or a slow heart rate, while not always directly diagnostic without additional context, is another important health metric for infants. By including bradycardia monitoring, Owlet’s device adds an additional layer of surveillance, helping to identify instances where bradycardia may be symptomatic of a more serious condition or occur in conjunction with desaturation events.

These reasons made me to conclude that desaturation monitoring led to Owlet’s FDA crackdown:

  • When Owlet reintroduced the Smart Sock in the market while awaiting FDA clearance, it was allowed to still monitor pulse rate but could only indicate oxygen level details in the app (10-mins average) with no live push notifications for blood oxygen level.
  • Many smart monitors such as Eufy S320 and Babytone have been untouched by FDA despite having units that monitor live pulse-rate readings.
  • Owlet only re-introduced live oxygen level reading and notifications after getting De Novo FDA clearance
  • Most other oxygen monitors such as Eufy S320 and Babytone give an average blood oxygen level and do not allow caregivers to set threshold for sending push notifications if the blood oxygen saturations falls below the threshold. In other words, the do not send live oxygen level notifications and can only do so after getting FDA clearance.

A device that is available for direct consumer purchase and is used for diagnostic purposes ought to be designated as a Class II medical device. Given that the Owlet product was not designed to substitute conventional monitoring, diagnostic, or treatment practices, it was reasonable for the FDA to require that Owlet obtain FDA clearance. This insistence ensures that such products meet regulatory standards for safety and efficacy, especially when they offer health-related insights directly to consumers.

The Significance of FDA Clearance for Owlet

FDA approval is a rigorous process that evaluates the safety and effectiveness of medical devices. For Owlet, obtaining FDA clearance means that its device has met high standards of performance and reliability. This approval is particularly important for devices that monitor conditions like desaturation, given the immediate and serious implications of oxygen deprivation in infants.

The FDA’s endorsement allows Owlet to give caregivers access to real-time data on their infant’s oxygen saturation levels and heart rate, offering an unprecedented level of insight into the baby’s well-being.

Case for monitoring vitals to prevent apnea:


As per an old paper by M.D. Warren G. Guntheroth, the concept of “near miss” events in infants suggests that apnea, or temporary cessation of breathing, is a likely primary factor in Sudden Infant Death Syndrome (SIDS).

The issue seems to stem not from the occurrence of apnea itself—which can be triggered by various reflexes and is somewhat common during sleep—but from an immature infant’s inability to resume breathing after an apnea episode. Infants, having not needed to breathe in the womb for nine months, may not instinctively respond to the need to restart breathing when experiencing apnea. Studies in both humans and animals indicate that respiratory infections and lack of sleep can increase both the likelihood and duration of sleep apnea episodes.

Should this primary apnea extend beyond a critical duration (45 seconds or more), it can lead to hypoxic apnea, characterized by a lack of oxygen. This condition can become self-perpetuating until it either leads to circulatory failure or is interrupted by a gasp for air.

While gasping can be an effective resuscitation method at birth, its efficacy diminishes after the neonatal period, typically around one month old, which coincidentally aligns with the observed decrease in SIDS cases during the first month of life.

Given these insights, infants who experience a “near miss” should ideally be monitored at home, if possible, up until the age of six months. In such cases, using a simple cardiac monitor to detect bradycardia (slow heart rate) is recommended as more advantageous than relying solely on an apnea monitor.

This approach underscores the importance of early detection and intervention in preventing SIDS, highlighting the critical role of continued monitoring in safeguarding infant health. But not all monitors are equal. Others have FDA clearance.

What Owlet’s FDA Clearance Means to you as a Parent:

The FDA clearance of Owlet’s Dream Sock signifies a significant endorsement of its safety and effectiveness for the intended use, bringing peace of mind to parents. This clearance means the product has undergone rigorous testing and review by the FDA to ensure it meets specific standards for consumer health devices. For parents, this translates to a higher level of trust in using the Owlet Dream Sock for monitoring the well-being of their infants.

The Owlet Dream Sock is designed to monitor vital signs such as heart rate and oxygen levels while the baby sleeps. FDA clearance confirms that the device can reliably provide these measurements and that it has met the required safety standards for home use. This doesn’t mean the Owlet Dream Sock replaces direct medical monitoring or professional advice but serves as an additional tool for parents to keep a close eye on their baby’s health in real time.

Furthermore, FDA clearance might also broaden the availability of the product, making it more accessible to parents looking for advanced monitoring solutions. It reassures parents about the quality and reliability of the device, knowing that it complies with federal regulations for health and safety.

In essence, FDA clearance elevates the credibility of the Owlet Dream Sock, assuring parents that it is a safe, reliable, and effective tool for monitoring their infant’s health parameters, which can be particularly comforting for new parents or those with concerns about their child’s well-being during sleep.

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