Pregnancy care that carries you
Paxxy is building a comfortable pregnancy wearable that gives parents and care teams continuous vital signs for mother and baby, at home or in the clinic. Validated in hospital against standard CTG. Investigational device, in development.
The problem
Standard pregnancy monitoring means clinic-based sessions of about fifteen minutes on a technician-operated machine, with results reported back hours or days later. Roughly 25–30% of pregnancies are higher-risk. 60–80% of mothers experience lower back pain and 25–50% already choose a pregnancy support band.
The band
One garment doing two jobs: taking physical load off the lower back, and holding an ECG electrode and accelerometer array against the skin for continuous fetal and maternal heart-rate readings.
How it works
Wear the band, see maternal and fetal heart rate and movement in the app, and share the same data with your care team between visits.
For clinicians
An in-hospital study of more than 30 mothers against standard CTG showed a bias under 1 bpm with a standard deviation under 3 bpm. We are recruiting pilot sites.
Where we are
Paxxy has a validated prototype, US manufacturing, a pre-submission FDA meeting held, and an initial quality system. Next is a US clinical study, then FDA 510(k) clearance with predicate. Paxxy cannot be sold in the US until clearance is granted.
Contact
Paxxy FMS Inc. — info@thepaxxy.com
Paxxy is an investigational device in development. It has not been cleared or approved by the FDA, is not available for sale, and no claims of safety or effectiveness are made.