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510(k)

Marani Health clears the M•care system for fetal and maternal monitoring at home

MedDevice Startups Staff · 20 hrs ago · 2 min read · Via PR Newswire

Marani Health cleared the M•care System through 510(k) on September 24. The clearance covers prescription fetal and maternal heart rate monitoring in the home.

The system pairs the M•wrap, a wearable that picks up signals through abdominal electrodes, with digital assessments and a channel back to the clinician. Marani lists the cleared device as the M•care System (MW-20). The Minneapolis company was formed in collaboration with Mayo Clinic, and says monitoring runs from prenatal care through the first year after delivery. CEO Ann Holder called the clearance the culmination of years of product development.

Availability is set for 2027, aimed at health systems and health plans rather than direct sales. Marani raised $3.7M in 2021 under its former name, Odonata Health, closed a $7M convertible note in 2024, and holds a $5M CDC grant with the University of Wisconsin-Madison. The distance between a clearance and a 2027 date is usually where the coverage and coding work sits.

Questions & Answers

What did Marani Health get FDA clearance for?

Marani Health received 510(k) clearance on September 24, 2026 for the M•care System (MW-20), including the M•wrap wearable. It is a prescription device for fetal and maternal heart rate monitoring in the home, using abdominal electrodes to capture signals and send them to clinicians.

When will the Marani Health M•care system be available?

Marani Health expects the M•care System to reach the market in 2027, selling through health systems and health plans rather than directly to patients.

Where is Marani Health based and how much has it raised?

Marani Health is based in Minneapolis, Minnesota and was formed in collaboration with Mayo Clinic. It raised $3.7M in 2021 under its former name Odonata Health, closed a $7M convertible note in 2024, and holds a $5M CDC grant with the University of Wisconsin-Madison.

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