BETA
Developing fetal pulse oximetry technologies for labor and delivery, with direct and external sensing platforms intended to complement fetal heart-rate monitoring.
Raydiant Oximetry is a privately held medical device company based in San Ramon, California, founded in 2016 by pediatric anesthesiologist Neil P. Ray, MD. Michael Nagel became CEO in September 2025, with Ray transitioning to a strategic advisory role.
The current fetal-monitoring portfolio comprises Nirah, a direct fetal sensor, and Lumerah, an external transabdominal platform. Both are in development. Earlier company materials also describe Daisy, a uterine drainage device; its current regulatory scope and commercial availability require reconciliation.
Raydiant and GE HealthCare announced a joint development initiative in May 2025. The company has reported studies at Eastern Virginia Medical School and LSU Health Shreveport, alongside venture financing, grants and prize funding. Clinical-study participation and development partnerships do not establish commercial adoption.
Nirah and Lumerah remain investigational. Company-reported Breakthrough designation and IDE-supported research do not authorize sale. For Daisy, a sponsor protocol describes an exemption for drainage while other material says FDA-cleared; no matched FDA clearance number or definitive current exemption scope was established, so neither status is assumed for hemorrhage-prevention claims. Daisy drainage exemption and hemorrhage-prevention labeling remain conflicting/unverified. [12][13][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [6][4]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
No commercially marketed product portfolio has been established in the reviewed material.
Cervical drainage device studied with low-level wall suction after scheduled cesarean delivery. Broader hemorrhage-related claims require confirmation against current labeling. [8][16][22][2]
Commercial availability not establishedInvestor reports early commercialization; current availability not independently established.
NCT06219538: registry status completed in the 2026-05-01 update; 10 participants (actual). [9]
External abdominal sensing platform using biophotonics and machine learning to investigate noninvasive fetal oxygenation monitoring. [12][10][17][21][2]
Investigational / in developmentIn development; positioned as the longer-term external monitoring platform.
Company reported over 40 hours of fetal oximetry data and FDA permission to expand the study to 30 patients. This is an enrollment update, not marketing clearance or proof the study remains recruiting. [24]
Company described fetal signal collection at EVMS with clinicians blinded to oximetry readings. Wire publication date used; company website lists October 16. Not a demonstration of improved birth outcomes. [20]
Nagel succeeded founder Neil Ray, who transitioned to a strategic advisory role. [19]
Rice University and Raydiant-affiliated authors reported time-domain NIRS experiments involving simulations, phantoms, a human forearm and a pregnant ewe. Findings do not establish clinical outcomes in laboring patients. [11]
Partners announced plans to co-develop integration of fetal oximetry with GE fetal monitoring and perinatal surveillance platforms. Agreement terms were undisclosed; no distribution relationship or commercial launch established. [10]
Raydiant reported first place in the NIH RADx Tech Fetal Monitoring Challenge. Original release date retained rather than later website listing date. [18]
Company reported grant support for Lumerah development and use of early-feasibility study data. [17]
Company announced an oversubscribed extension led by Cross-Border Impact Ventures, with RH Capital, Global Health Impact Fund, VCapital and March of Dimes Innovation Fund participating. Proceeds supported fetal-monitoring and Daisy studies. [22]
Company announced an undisclosed March of Dimes Innovation Fund investment to begin Series B financing; a completed round is not established. [15]
Accessed 10/29/2026