PeriWatch Vigilance

What does Vigilance do?

The vendor says Vigilance uses supervised machine learning to interpret fetal heart rate patterns and detect uterine contractions. Its product page describes a multi-patient Hub Board, fetal heart rate trend analysis, a labor progression curve adjusted for contraction frequency, epidural use and parity, and a mobile app.

A post on responsible AI says the model is static, trained on more than 1,800 hours of curated tracings, uses no demographic inputs and signs in through the hospital's single sign-on. The vendor's line is that AI "is meant to complement clinical expertise, never replace it".

Which FDA record is this, and which product does it cover?

K241009 is "PeriCALM Patterns 3.0", applicant Perigen, Inc., product code HGM (obstetrics and gynecology), a Traditional 510(k) with a substantially equivalent decision on January 10, 2025. It is the only record the openFDA search returned.

The vendor calls Surveillance "a 510k-cleared medical device" and says "PeriGen's products are FDA-cleared Class II medical devices". It prints no clearance numbers. The Vigilance page says a clearance extending monitoring from 36 weeks to 32 weeks is "coming soon in a future version".

What has been published?

PubMed returns no hits for "PeriWatch" and three for "PeriCALM". They are a 2010 comparison of five experts with computer analysis in rule-based fetal heart rate interpretation (American Journal of Obstetrics and Gynecology, PMID 20633869), a 2018 Obstetrics and Gynecology paper on tracings in small-for-gestational-age and appropriately grown neonates (PMID 30204687), and a 2024 American Journal of Perinatology paper on fetal tachycardia with maternal intrapartum fever (PMID 34670321).

PeriGen authors also published on labor curves in the American Journal of Obstetrics and Gynecology in 2024 (PMID 38423450) and 2025 (PMID 40316040), and on opportunities in fetal heart rate monitoring in BJOG in 2025 (PMID 39971749). The labor-curve and heart-rate papers concern algorithms and datasets, not outcome trials of the product. The vendor's research page also lists a 2021 American Journal of Perinatology study from Ochsner on centralized remote fetal monitoring and unexpected term NICU admissions.

Who owns it and where is it used?

PeriGen, Inc. joined Halma plc in 2021. Matthew Sappern is CEO. The homepage cites 31-plus years of experience and gives no founding year or headquarters. The vendor claims 775,000 or more births supported each year in the US and Canada at 500-plus hospitals, and the homepage mentions Baptist Health, NYC Health + Hospitals, OhioHealth and Mount Sinai.

The vendor says Vigilance integrates with all industry-standard EMRs and names none. A SOC 4 logo links to AICPA. HIPAA, HITRUST, ISO 27001 and BAA terms are not stated.

The product pages direct buyers to "Talk to an Expert" and list no tiers, trial or refund terms.

The verdict

Vigilance is sold under one name and the clearance on record carries another, and the vendor's pages do not connect them. The research behind the underlying algorithms is PeriGen-authored, and the outcome study the vendor lists comes from Ochsner.