FDA Events for Sensus Healthcare (SRTS)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Sensus Healthcare (SRTS).
Over the past two years, Sensus Healthcare has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SRT-100. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SRT-100 - FDA Regulatory Timeline and Events
SRT-100 is a drug developed by Sensus Healthcare for the following indication: In Preventing Keloid Recurrence.
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:
- SRT-100
- Announced Date:
- March 4, 2025
- Indication:
- In Preventing Keloid Recurrence
Announcement
Sensus Healthcare, Inc announces the publication of a study titled "Keloid Excision With Primary Closure Combined With Superficial Radiation Therapy (SRT-100)" in the Annals of Plastic Surgery..
AI Summary
Sensus Healthcare, Inc. has announced the publication of a study titled “Keloid Excision With Primary Closure Combined With Superficial Radiation Therapy (SRT-100)” in the Annals of Plastic Surgery. This single-site, retrospective study evaluated the clinical outcomes of using the SRT-100® system following surgical keloid excision and primary wound closure. Conducted at Tri Service Military Hospital in Taiwan, the study included 12 patients with 16 keloids and showed no keloid recurrence in most patients at follow-up visits beyond six months, highlighting the promising potential of combining surgery with adjuvant superficial radiation therapy.
This study marks Sensus Healthcare’s first research publication in Asia and underscores the company’s commitment to improving keloid management by targeting the underlying fibroblast activity responsible for keloid regrowth. The promising results suggest that integrating SRT can lead to a more reliable, non-invasive treatment solution that enhances long-term patient outcomes.
Read Announcement
Sensus Healthcare FDA Events - Frequently Asked Questions
As of now, Sensus Healthcare (SRTS) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sensus Healthcare (SRTS) has reported FDA regulatory activity for SRT-100.
The most recent FDA-related event for Sensus Healthcare occurred on March 4, 2025, involving SRT-100. The update was categorized as "Publication," with the company reporting: "Sensus Healthcare, Inc announces the publication of a study titled "Keloid Excision With Primary Closure Combined With Superficial Radiation Therapy (SRT-100)" in the Annals of Plastic Surgery.."
Currently, Sensus Healthcare has one therapy (SRT-100) targeting the following condition: In Preventing Keloid Recurrence.
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:SRTS) was last updated on 7/13/2025 by MarketBeat.com Staff
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