{"id":6868,"date":"2023-11-10T16:52:16","date_gmt":"2023-11-10T21:52:16","guid":{"rendered":"https:\/\/lifescivoice.com\/?p=6868"},"modified":"2023-11-10T16:52:18","modified_gmt":"2023-11-10T21:52:18","slug":"after-success-with-its-babysat-system-owlet-gains-fda-clearance-for-its-dream-sock","status":"publish","type":"post","link":"https:\/\/lifescivoice.com\/after-success-with-its-babysat-system-owlet-gains-fda-clearance-for-its-dream-sock\/","title":{"rendered":"After success with its BabySat system, Owlet gains FDA clearance for its Dream Sock"},"content":{"rendered":"\n<p>Owlet, the innovative baby monitoring system company, is celebrating a significant milestone as it secures FDA clearance for its Dream Sock technology. This achievement marks a notable turnaround, considering that a similar system had previously drawn the ire of the regulatory body due to concerns about its functionality.&nbsp;<\/p>\n\n\n\n<p>The Dream Sock, a flexible, sock-like device designed for babies between one to 18 months weighing six to 30 pounds, has now been granted de novo clearance, allowing it to provide real-time heart rate and oxygen saturation measurements through a smartphone app.<\/p>\n\n\n\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script>\n<ins class=\"adsbygoogle\" style=\"display:block; text-align:center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins>\n<script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script>\n\n\n\n<p>The central component of the Dream Sock is a sock-like device embedded with a sensor that tracks vital signs such as pulse rate and oxygen saturation. Additionally, it monitors sleep length and cycles, transmitting this valuable data wirelessly to a dedicated app on caregivers&#8217; smartphones.&nbsp;<\/p>\n\n\n\n<p>While the product was initially available for monitoring sleep quality indicators, the recent FDA clearance elevates its capabilities by enabling the display of real-time heart rate and oxygen saturation measurements on the app. Furthermore, an alarm will now be triggered if these measurements deviate from predetermined healthy ranges.<\/p>\n\n\n\n<p>Owlet&#8217;s announcement highlights that these enhanced features will be rolled out to both existing and new Dream Sock users by year end.&nbsp;<\/p>\n\n\n\n<p>This positive development rectifies a past misstep for Owlet, which faced an FDA warning letter in 2021, leading to the withdrawal of a similar monitoring system known as the Smart Sock from the market. The Smart Sock, intended for children up to 5 years old, was sold over the counter without FDA oversight. The FDA argued that, despite Owlet&#8217;s claims that the technology was purely for monitoring and not for diagnosing or treating diseases, the potential diagnostic applications warranted classification as a medical device.<\/p>\n\n\n\n<p>During that period, the FDA indicated that it had engaged in discussions regarding the alleged misclassification dating back to 2016.&nbsp;<\/p>\n\n\n\n<p>The recent FDA clearance not only validates the Dream Sock&#8217;s accuracy but also signifies Owlet&#8217;s commitment to improving infant care technology. The company plans to continue its research efforts to introduce new technologies and enhance accuracy in infant monitoring.&nbsp;<\/p>\n\n\n\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script>\n<ins class=\"adsbygoogle\" style=\"display:block; text-align:center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins>\n<script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script>\n\n\n\n<p>Owlet&#8217;s journey includes a prior FDA clearance earlier this year for the BabySat system, a counterpart to the Dream Sock. While sharing similarities with the Dream Sock in terms of health alerts, the BabySat requires a doctor&#8217;s prescription and is specifically indicated for infants diagnosed with acute or chronic medical conditions under medical supervision.<\/p>\n\n\n\n<p>Owlet&#8217;s success in navigating FDA clearance for the Dream Sock demonstrates the company&#8217;s dedication to advancing infant monitoring technology while ensuring compliance with regulatory standards. As the upgraded features reach users by year-end, parents and caregivers can look forward to an improved monitoring experience for their infants, with real-time data accessible at their fingertips.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Owlet, the innovative baby monitoring system company, is celebrating a significant milestone as it secures FDA clearance for its Dream Sock technology. This achievement marks a notable turnaround, considering that a similar system had previously drawn the ire of the regulatory body due to concerns about its functionality.&nbsp; The Dream Sock, a flexible, sock-like device [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6869,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[],"class_list":{"0":"post-6868","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-regulatory"},"_links":{"self":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/6868","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/comments?post=6868"}],"version-history":[{"count":1,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/6868\/revisions"}],"predecessor-version":[{"id":6870,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/6868\/revisions\/6870"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media\/6869"}],"wp:attachment":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media?parent=6868"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/categories?post=6868"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/tags?post=6868"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}