Upon receipt of a warning letter from the US Food and Drug Administration, a Utah-based tech startup outlet, the baby sock inventor that monitors the baby’s vital signs, will cease selling the product until it is approved by the federal agency.
The company reported that it has sold more than 1 million monitoring socks since its launch in 2015 and said it will continue to support those who have already purchased the product. Although the FDA does not address any safety concerns, it does not ask for the product to be recalled, and the sale of monitors pending FDA approval has been halted.
“Owl Receives FDA Warning for Smart Sock Regulatory Status in the United States” The owl reads an unsigned post on the website. “The letter we received from the agency did not address any safety concerns about the Smart Sock; instead, the FDA asserts that the Smart Sock should be classified as a medical device in the US because of heart rate and oxygen indications.
The owl’s infant footprint monitors vital signs, such as oxygen levels and heart rates, and transmits information to the smartphone app if the data moves to an unsafe level. While the product is currently not on the shelves, the company said it will have another monitoring product coming online soon.
“As a result of the letter and in light of our plans to submit a device application to the FDA, we are no longer selling Smart Sock,” the web posting reads. “We plan to offer a new sleep monitoring solution, which we hope will be available soon. We plan to continue to support our current customers. This action is specific to the US and is not affected by any other countries or regions.
According to business data aggregator Crunchbase, Owl has attracted nearly $ 180 million in venture support since its founding six years ago and has grown beyond the monitoring sock to include other baby-centric products, including monitoring cameras, sleep software and clothing.
In a 2017 profile, Ooulette co-founder and CEO Kurt Blackman spoke about the trauma his wife suffered when she was an infant with congenital heart failure, which prompted the idea of becoming a sock monitor.
“Ten days after my wife’s parents brought her home from the hospital, they returned her for emergency heart surgery,” Workman said.
He went on to have two additional heart surgeries.
When she visited her wife’s cardiologist several years before the company started, the worker’s thoughts returned to what she experienced as a child and what she could do to keep their future child safe, to see if pregnancy was the safest option.
“Our child had the opportunity to make the same mistake and I was worried about it,” she said. “How do I know if something’s wrong?”
Instead of waiting for an answer, Workman took it upon himself to come up with a solution. She consulted with a nurse friend at the University Hospital. Together, they began working on a method to incorporate pulse oximetry technology – which surgeons attach to your fingertips to monitor oxygen levels – making the baby wireless and efficient.
While the company has continued to attract and attract tens of millions of investments since its debut, the concerns about the device are not new.
In January 2017, the Journal of the American Medical Association published an editorial with a decisive warning on digitally connected infant monitors. The article noted that “there is no medical instruction to monitor healthy infants in the home,” and the lack of publicly available evidence supporting the safety, accuracy, and effectiveness of Food and Drug Administration-approved owl monitors.
However, the piece goes on to note that “the current market for smartphone apps combined with sensors that monitor infant vital signs is innovative and has the potential to improve care.”
New technology companies have the distinction of pushing the envelope of the established regulatory arena, and some of the conflicts raised by companies such as Uber, Lyft and Airbnb have played out in public settings.
The authors of the article also refer to what can be interpreted as a disconnect between the current process and the technological advances that can be overcome.
“It is challenging to strike a balance between fostering innovation while providing optimal and effective control in the rapidly expanding mobile medical app market,” the article said.