Re-submit TDI 510(k) application for product innovation
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 5 Feb 2025
- Due
- 30 Jun 2025
- Delivered
- March 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“plans to re-submit our TDI 510(k) application in the first half of 2025”
What we found
Evidence strength D What the grades mean
Sensus Healthcare resubmitted its TDI 510(k) application in early March 2025, before the first-half-2025 deadline it had announced.
-
D Sensus Healthcare, Inc. (NASDAQ:SRTS) Q1 2025 Earnings Call Transcript Company states 510(k) resubmitted in early March 2025.
-
D Sensus Healthcare, Inc. (NASDAQ:SRTS) Q2 2025 Earnings Call Transcript Confirms 510(k) resubmission remains under FDA review as of Q2 2025.
-
D Earnings call transcript: Sensus Healthcare misses Q1 2025 EPS forecast Confirms resubmission in early March with FDA review underway.
-
D Sensus Healthcare details 2025 loss and growth plans | SRTS SEC Filing - Form 10-K FY2025 10-K notes company not yet offering TDI (final clearance pending).
Checked 12 Sep 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory filing
- Indicative materiality
- Medium rules
- Action
- Re-submit
- Language
- Expected (“expects”, “plans”)
How this entry was checked
- Commitment recordedRecorded from the company's filing.
- First checkAn AI model read the company's later filings and recorded the outcome with a quoted passage.
- Second checkThe evidence document could not be read for a second check.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
Are you Sensus Healthcare, Inc.? You can publish an official statement next to this entry, free. Add a statement.
Is something here wrong or out of date? Companies and readers can ask us to check it. Please bring a link to a public source.
Report an error in this entry Reference: KI-C-2025-SRTS-000225 · Corrections policy