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Sibel Health, a medical technology company, has received FDA 510(k) clearance for ANNE Maternal, a wireless maternal-fetal monitoring platform that integrates wearable sensor technology with clinical decision support.
The Chicago-based company's ANNE Maternal uses flexible epidermal wearable sensors that continuously and wirelessly stream a woman's vital signs, including respiratory rate, blood oxygen, skin temperature and heart rate. It also monitors fetal heart rate and uterine contraction detection.
The platform includes visual and audio alarms as well as an integrated Modified Early Obstetric Warning System (MEOWS) that gives providers automated signals when prompt evaluation is needed.
ANNE Maternal is the sister product of the company's FDA-cleared ANNE One, a monitoring platform for adolescents 12 and older and adults in the home and hospital settings. ANNE One includes wearable sensors, AI-enabled data analytics, and an integrated mobile software and cloud platform.
"What makes this platform truly unique is its dual mandate: It meets the rigorous clinical standards demanded by the FDA while also being designed for deployment in the world's most resource-limited settings. That convergence – high-income market validation and global health impact in a single platform – is what we've been building toward since day one," Steve Xu, MD, CEO and cofounder of Sibel Health, said in a statement.
THE LARGER TREND
In February, Sibel Health, a spin-out of Northwestern University, announced that the FDA accepted its letter of intent into the Clinical Outcome Assessment (COA) Qualification Program under the Drug Development Tool (DDT) framework for its wearable cough monitoring sensor for adult patients with chronic refractory cough, dubbed Aria.
Sibel previously received FDA DDT COA acceptance for its scratch sensor for atopic dermatitis and a swallow sensor for Parkinson's disease.
That same month, the company announced a strategic partnership with AI-enabled fall prevention platform LookDeep Health to combine Sibel's wearables monitoring with LookDeep's real-time computer vision AI for patients in emergency departments, inpatient units and for transitions from the hospital to the home.
In March of last year, Sibel announced it had closed a $30 million Series C equity financing round and in October unveiled an extension of that round to $39 million.
In 2024, the medical technology company was selected by the capital region of Denmark for a long-term partnership, in conjunction with medical safety technology company Dräger, to deploy ANNE One across multiple hospitals in the Copenhagen area.
The collaboration included a four-year purchase agreement and installation in more than 1,000 hospital beds, with an estimated purchase value exceeding $20 million (141 million DKK).
Sibel's platform is also expected to be used in other Danish regions over a 10-year period with a total estimated purchase value in excess of $100 million (706 million DKK).
In 2022, Sibel Health scored $33 million in a Series B funding round led by the Steele Foundation for Hope. The company used the funds to deploy its ANNE One platform for in-home and hospital monitoring.
