FDA Events for Movano (MOVE)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Movano (MOVE).
Over the past two years, Movano has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
EvieMED. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
EvieMED - FDA Regulatory Timeline and Events
EvieMED is a drug developed by Movano for the following indication: Device Study.
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:
- EvieMED
- Announced Date:
- December 2, 2024
- Indication:
- Device Study
Announcement
Movano Health announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring.
AI Summary
Movano Health announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the pulse oximeter in its EvieMED Ring. This clearance is an important milestone for the company, as it validates the device’s ability to measure blood oxygen (SpO₂) levels and heart rate accurately in a clinical setting. The approval allows Movano Health to tap into a vast $40 billion market focused on healthcare B2B opportunities, including clinical trials, post-clinical trial management, and remote patient monitoring. The EvieMED Ring is designed to provide a comfortable and reliable usage experience, overcoming the limitations of conventional pulse oximeters by ensuring accuracy even for users with darker skin tones and accommodating finger swelling. This clearance paves the way for further collaborations with healthcare providers, payors, and pharmaceutical companies as the company looks to expand its portfolio with additional clearances and functionalities in the future.
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Movano FDA Events - Frequently Asked Questions
As of now, Movano (MOVE) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Movano (MOVE) has reported FDA regulatory activity for EvieMED.
The most recent FDA-related event for Movano occurred on December 2, 2024, involving EvieMED. The update was categorized as "FDA Clearance," with the company reporting: "Movano Health announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the pulse oximeter in its EvieMED Ring."
Currently, Movano has one therapy (EvieMED) targeting the following condition: Device Study.
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:MOVE) was last updated on 7/10/2025 by MarketBeat.com Staff
