Owlet™ Secures CDSCO Approval for Dream Sock® and Plans 2026 Expansion into India
Owlet expands its global footprint, entering one of the world's most promising digital health markets, with CDSCO-approved technology.
Owlet, Inc. ("Owlet" or the "Company") (NYSE:OWLT), the pioneer of smart infant monitoring, today announces that the Central Drugs Standard Control Organization (CDSCO) approved Dream Sock® for distribution. This marks a significant milestone for the Company as it now prepares to launch its integrated monitoring devices, including Dream Sock®, Dream Sight™, and Dream Duo™, across India in early 2026.
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Owlet Dream Duo, including Dream Sock and Dream Sight.
With approval from the CDSCO, India's national regulatory body for cosmetics, pharmaceuticals, and medical devices, Owlet becomes one of the few infant health technology companies to meet the region's stringent medical device requirements, further validating its commitment to clinical rigor and innovation. As smartphone penetration exceeds 80% in urban centers, India's connected-home environment provides a strong foundation for the adoption of Owlet's technology.
"India's rapidly evolving digital health ecosystem aligns perfectly with our mission to make infant care smarter and more accessible for every family," said Jonathan Harris, Owlet's President and CEO. "With more than 23 million babies expected to be born in 2025, the highest of any country in the world, India represents a vital opportunity to support new parents during this most important journey. The country is a strategic growth market, where the convergence of digital adoption, healthcare modernization, and an expanding urban middle class is driving demand for smart, connected health solutions."
Owlet's technology supports India's broader healthcare priorities of improving infant health outcomes and empowering parents with early detection tools. The Company's suite of award-winning products, expected to be available in India in early 2026, includes:
- Dream Sock, a wearable smart baby monitor that is designed for healthy infants between 0-18 months or 2.5-13.6 kg, tracks key vitals in real-time, such as oxygen level and pulse rate, along with sleep trends, providing clinically validated insights.
- Dream Sight, Owlet's latest intelligent audio and video camera, which offers secure, high-definition monitoring for around-the-clock visibility while detecting motion, sound, and crying.
- Dream Duo, the ultimate all-in-one monitoring system, combines Dream Sock and Dream Sight for real-time vital alerts and a complete view of Baby's wellness and sleep.
- Dream App, a simple, convenient App where families can view live health readings in real-time. Both the Dream App and the included Base Station provide notifications if measurements fall outside preset ranges.
Trusted by over 2 million families across more than 30 countries, the launch of Owlet products in India will bring clinical-grade insights to families seeking the best in infant care. The Company's suite of products is expected to be available for purchase across India early next year, at retail and select baby specialty stores. For more information, please visit www.owletcare.com and sign up for emails to be the first to know about company news and future product releases.
About Owlet, Inc.
Owlet's digital health infant monitoring platform is transforming the journey of parenting. The Company (NYSE:OWLT), a small-cap healthcare growth equity, offers FDA-cleared medical and consumer pediatric wearables and an integrated HD visual and audio camera that provide real-time data and insights to parents who safeguard health, optimize wellness, and ensure peaceful sleep for their children.
Since 2012, over two million parents worldwide have used Owlet's platform, contributing to one of the largest collections of consumer infant health and sleep data. The Company continues to develop software and digital data solutions to bridge the current healthcare gap between hospital and home and bring new insights to parents and caregivers globally. Owlet believes that every child deserves to live a long, happy, and healthy life. To learn more, visit www.owletcare.com.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Reform Act"). All statements other than statements of historical fact are forward-looking statements, including, without limitation, statements regarding the Company's planned launch, distribution and commercialization of Dream Sock®, Dream Sight™ and Dream Duo™ in India, the related anticipated timing, market opportunity and strategic impact, as well as the Company's growth prospects, product development, cost-reduction initiatives and international expansion plans. In some cases, forward-looking statements may be identified by words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," or similar expressions and their negations. These statements are based on the Company's current expectations, assumptions and beliefs as of the date of this release and are subject to numerous risks and uncertainties, many of which are beyond the Company's control. Actual results may differ materially from those expressed or implied due to factors including, but not limited to: (i) the Company's ability to maintain existing regulatory clearances and authorizations, comply with ongoing regulatory requirements, and obtain additional clearances or approvals for future product modifications or new markets as needed from the Central Drugs Standard Control Organization ("CDSCO"), the U.S. Food and Drug Administration ("FDA") and comparable foreign authorities; (ii) the timing and success of the commercial launch and distribution of Dream Sock, Dream Sight, and Dream Duo in India and other international markets, including factors affecting market readiness, localization, supply chain and consumer adoption; (iii) the Company's competition and its ability to profitably grow and manage growth; (iv) the Company's ability to implement strategic initiatives, reduce costs, develop and launch new products, innovate and enhance existing products, meet customer demands and adapt to changes in consumer preferences and retail trends; (v) the Company's ability to acquire, defend and protect its intellectual property and satisfy regulatory requirements concerning privacy and data protection; (vi) the Company's ability to maintain relationships with customers, manufacturers and suppliers; (vii) impacts from compliance with applicable laws or regulations, including emerging data-localization and privacy laws in international markets; (viii) the impact of and disruption to the Company's business, financial condition, operations, supply chain and logistics due to economic or other conditions beyond the Company's control; (ix) adverse impacts from other economic, business, regulatory, competitive or other factors, such as changes in discretionary consumer spending and consumer preferences; and (x) other risks and uncertainties set forth in the Company's other releases, public statements and filings with the U.S. Securities and Exchange Commission ("SEC"), including those identified in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in its subsequent Quarterly Reports on Form 10-Q and other filings with the SEC. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. The Company operates in an evolving environment, and new risk factors and uncertainties may emerge from time to time. Except as required by law, the Company assumes no obligation to update any forward-looking statements after the date of this press release, whether as a result of new information, future events or otherwise. The Company does not endorse any projections regarding future performance that may be made by third parties.
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