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Owlet Gains From FDA Clarity: Does Regulation Create an Edge?
ZACKS· 2026-01-14 16:01
Core Insights - Owlet, Inc. (OWLT) is positioned favorably due to increased regulatory clarity in the infant monitoring market, enhancing its competitive edge over time [1][4] - The company is the first and only FDA-cleared over-the-counter infant monitoring device provider, which is crucial as the FDA has issued warnings against unauthorized devices [2][9] - Owlet's FDA clearance validates product reliability for parents and reduces compliance risks for retailers and healthcare partners, suggesting a more defensible market position compared to competitors without clearance [3][9] Regulatory Developments - Regulatory differentiation is a significant factor supporting Owlet's long-term outlook, as it reinforces credibility and raises barriers to entry in the market [2][4] - The FDA's safety communication has created a clear distinction between regulated and unregulated products, benefiting Owlet's market positioning [2][9] Financial Performance - In Q3 2025, Owlet reported over 85,000 paying subscribers for its Owlet360 subscription platform, with attach rates exceeding 25%, indicating strong customer engagement [4][9] - The Zacks Consensus Estimate for OWLT's 2026 loss has narrowed to 25 cents from 48 cents in the past 30 days, with an expected loss of 12 cents per share in 2025 [11] Competitive Landscape - Competition in the connected infant monitoring and digital health sectors remains intense, with companies like Masimo and iRhythm Technologies influencing adjacent segments [5][6] - Owlet's focus on infant health, combined with its FDA-cleared consumer approach, may lead to deeper engagement if execution remains on track [7] Market Performance - Owlet's shares have increased by 69.1% over the past six months, outperforming the Zacks Electronics - Miscellaneous Products industry's growth of 26.3% and the Zacks Computer and Technology sector's rise of 19.2% [8]