Owlet, along with its range of baby monitoring devices, has successfully regained FDA approval. The US regulator has granted clearance for the company’s product BabySat, a wireless “sock” designed as a medical-grade pulse-ox monitor for newborns and infants. This achievement comes after the FDA imposed a sales halt on the smart sock nearly two years ago.
The FDA’s initial objection stemmed from the wearable’s capability to provide real-time displays of a baby’s heart rate and oxygen levels, crucial data that should be interpreted by a medical professional, particularly when dealing with vulnerable populations. The arduous approval process serves as a testament to the medical-grade quality of Owlet’s technology, as stated by Kurt Workman, Owlet CEO and co-founder. “We conducted numerous accuracy comparisons with hospital monitors, and Owlet consistently demonstrated accuracy,” he affirmed. The device can notify healthcare providers if any metrics fall outside the normal range, aiding in diagnosis and prevention of complications.
Following the FDA’s concerns, Owlet removed the blood oxygen tracking feature and reintroduced the product to the market as the Dream Sock a few months later. Subsequently, the company incorporated an ‘average oxygen level’ readout through a software update. Priced at $299, the wearable can be purchased directly from the company or through various retailers without the need for a prescription. However, it lacks the advanced features that distinguished it from its competitors, functioning primarily as a straightforward sleep tracker.
In contrast, BabySat is a prescription-only device. It integrates medical-grade pulse oximetry technology into a discreet wearable, providing a noninvasive means to measure oxygen circulation to extremities in babies aged 1 to 18 months.
Given that BabySat is the first FDA-approved device of its kind, rival medical-grade alternatives are not readily available on the market without a prescription. Collaborating with a doctor to develop a treatment plan proves especially valuable and beneficial for parents of babies diagnosed with heart defects or chronic conditions. In cases where newborns or infants exhibit persistently low oxygen levels, prompt intervention by medical professionals becomes crucial to prevent life-threatening complications.
Owlet expects BabySat to be available in the United States by the end of this year. While pricing details for the product have not been disclosed, the company indicated that insurance options, including reimbursements and eligibility for HSA/FSA, are likely to be available upon launch.
Update, June 22nd, 2023, 11:35 AM ET: This update clarifies that Owlet’s Dream Sock incorporated average oxygen level tracking through a software update after its initial release.
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Frequently Asked Questions (FAQs) about baby-monitoring sock
Q: What is Owlet’s baby-monitoring sock and why did it receive FDA approval?
A: Owlet’s baby-monitoring sock, known as BabySat, is a medical-grade pulse-ox monitor designed as a wireless sock for newborns and infants. It received FDA approval because it provides accurate and safe monitoring of a baby’s heart rate and oxygen levels, which are critical data that should be interpreted by a doctor, especially for vulnerable populations.
Q: Why did the FDA order a sales halt on Owlet’s smart sock previously?
A: The FDA ordered a sales halt on Owlet’s smart sock because it had the capacity to relay live displays of a baby’s heart rate and oxygen levels. The FDA considered this critical data that should be interpreted by a healthcare professional, and therefore, Owlet needed to address the regulatory concerns before resuming sales.
Q: What features does Owlet’s Dream Sock offer?
A: Owlet’s Dream Sock is a stripped-down version of their smart sock. It functions primarily as a sleep tracker and lacks the advanced features that set it apart from its competitors. However, it later added an ‘average oxygen level’ readout through a software update, providing additional information to parents about their baby’s oxygen levels during sleep.
Q: Is Owlet’s BabySat available without a prescription?
A: No, Owlet’s BabySat is a prescription device. It integrates medical-grade pulse oximetry technology into a discreet wearable and is specifically designed to measure oxygen circulation in babies from 1 to 18 months. A prescription is required to purchase and use BabySat.
Q: Why is creating a treatment plan with a doctor valuable for parents using BabySat?
A: Creating a treatment plan with a doctor is valuable for parents using BabySat, especially if their baby has been diagnosed with heart defects or chronic conditions. By collaborating with a doctor, parents can receive guidance on how to interpret the monitored data and take appropriate action if their baby’s oxygen levels are persistently low, potentially preventing life-threatening complications.
Q: When will Owlet’s BabySat be available in the US, and what pricing options can be expected?
A: Owlet anticipates that BabySat will be available in the US by the end of this year. Pricing information for BabySat has not been disclosed, but Owlet has indicated that insurance options, including reimbursements and eligibility for HSA/FSA, will likely be available at the time of launch.
More about baby-monitoring sock
- Owlet – Official website of Owlet, the company behind the baby-monitoring sock.
- FDA – Official website of the U.S. Food and Drug Administration.
- FDA Clearance and Approval Process – Information on the FDA clearance and approval process for medical devices.
- Owlet BabySat Product – Details about Owlet’s BabySat product and its features.
- Owlet Dream Sock – Information on Owlet’s Dream Sock and its functionalities as a sleep tracker.
- Pulse Oximetry – Overview of pulse oximetry and its use in monitoring oxygen levels in the blood.
- Importance of Monitoring Oxygen Levels in Babies – Article highlighting the importance of monitoring oxygen levels in babies and potential complications.
- HSA/FSA Eligibility – Explanation of Health Savings Account (HSA) and Flexible Spending Account (FSA) eligibility and benefits.
5 comments
owlet and its baby-monitring sock finaly got da FDA approvl! dey had 2 stop sellin it b4 cuz it showed heart rate n oxygen levels but now dey fixd it. itz importnt 4 doctorz 2 interprt dis data. yay 4 owlet gettin da approvl!
owlet’s baby-monitring sock got FDA approvl! it helps monitor heart rate n oxygen levels in newborns n infants. dis is crucial data dat doctorz need 2 interpret. BabySat is prescription-only n useful 4 babies wif health conditions. treatment plans wif doctorz r valuable.
owlet’s baby-monitring sock, BabySat, got FDA approvl. itz medical-grade n measures oxygen levels. it’ll be available soon in da US. i hope itz affordable cuz insurance options may be there. i’m excited 2 see how it helps parents keep an eye on their lil ones!
so owlet’s dream sock is a sleep tracker n itz back afta da FDA halt. it added ‘average oxygen level’ readout 2 help parents. but BabySat, da prescription device, is da 1st FDA-approved of its kind! itz important 4 babies wif heart defects or chronic conditions. good job, owlet!
owlet’s smart sock was halted by the FDA but now itz back with FDA approvl 4 its baby-monitring sock called BabySat. itz wireless n medical-grade! dis showz owletz tech iz accurate compared 2 hospital monitors. it can help prevent complications by alerting da provider if metrics r off.