FDA Events for Masimo (MASI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Masimo (MASI).
Over the past two years, Masimo has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Masimo. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Masimo SafetyNet - FDA Regulatory Timeline and Events
Masimo SafetyNet is a drug developed by Masimo for the following indication: To Facilitate Early Discharge of Premature Newborns from the Hospital.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Masimo SafetyNet
- Announced Date:
- September 9, 2024
- Indication:
- To Facilitate Early Discharge of Premature Newborns from the Hospital
Announcement
Masimo announced that Saint-Denis Hospital Center is adopting the use of the Masimo SafetyNet® cloud-based telemonitoring platform as part of an experimental mobile neonatology unit aimed at facilitating earlier discharge of premature newborns from the ICU to the home. Launched in February, this pioneering project allows vulnerable neonates to return home safely to their families while remaining under the close supervision of the hospital.
AI Summary
Masimo announced that Saint-Denis Hospital Center in France is now using its SafetyNet® cloud-based telemonitoring platform as part of a pioneering mobile neonatology unit. Launched in February, this innovative project is designed to help unstable premature newborns leave the ICU earlier and safely return home. The platform uses a small, wireless pulse oximetry sensor worn on the baby’s foot, which sends health data to an easy-to-use smartphone app. This allows parents and healthcare teams to monitor the infant’s vital signs continuously.
The system creates a secure link between the hospital and the family, ensuring expert oversight even after discharge. With this technology, the hospital provides hospital-grade monitoring in the comfort of the home, easing the transition for vulnerable neonates and their families while maintaining rigorous medical supervision.
Read Announcement
Masimo FDA Events - Frequently Asked Questions
As of now, Masimo (MASI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Masimo (MASI) has reported FDA regulatory activity for Masimo SafetyNet.
The most recent FDA-related event for Masimo occurred on September 9, 2024, involving Masimo SafetyNet. The update was categorized as "Provided Update," with the company reporting: "Masimo announced that Saint-Denis Hospital Center is adopting the use of the Masimo SafetyNet® cloud-based telemonitoring platform as part of an experimental mobile neonatology unit aimed at facilitating earlier discharge of premature newborns from the ICU to the home. Launched in February, this pioneering project allows vulnerable neonates to return home safely to their families while remaining under the close supervision of the hospital."
Currently, Masimo has one therapy (Masimo SafetyNet) targeting the following condition: To Facilitate Early Discharge of Premature Newborns from the Hospital.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:MASI) was last updated on 7/10/2025 by MarketBeat.com Staff
