FDA
The regulatory path for S-WAVE™, and the numbers behind AI-enabled imaging
S-WAVE™ is not cleared or approved by the FDA. This page explains the pathway we plan to follow, what FDA will require, and how often it has authorized AI-enabled imaging devices.
Pathway
Home-use authorization comes first
Bench prototype
Full-arch 3D scans from the laboratory bench; patent portfolio acquired.
Pre-Submission
Ask FDA to confirm 510(k) vs De Novo for a home-use intraoral ultrasound imaging device with remote dentist review.
Testing
Acoustic output and safety, biocompatibility, software V&V, AI standalone and clinical accuracy, lay-user human factors.
Submission
eSTAR with a Predetermined Change Control Plan for the AI. Imaging and monitoring indication only.
Launch
Consumer-direct and practice channels; updates under the change control plan; post-market surveillance.
Target dates are estimates and may be delayed. The FDA could require more testing than we expect, or may never authorize S-WAVE™; consumer home use may face a higher bar than in-office devices.
AI-enabled devices
How often FDA authorizes AI imaging: the numbers
AI/ML-enabled devices authorized cumulatively through Dec. 31, 2025
in radiology, the specialty that includes ultrasound (1,104 devices)
authorized through the 510(k) pathway; the rest via De Novo and PMA
Annual authorizations, 2019–2025
Counts from an industry tracker; 2025 alone saw 295, and the first half of 2026 continued at a similar pace. A roughly 49× increase since 2015.
Ultrasound AI milestones
First AI guidance for novice cardiac ultrasound (De Novo, 2020); automated echo measurements; AI-assisted point-of-care ultrasound on handheld devices. Each established that software can make ultrasound usable by non-experts.
Dental AI milestones
Radiograph AI for caries and bone loss (510(k), as aids to dentists); AI analysis of patient-taken dental photos with clinician review (De Novo, 2023).
What this means for S-WAVE™
The pathway exists and is used hundreds of times a year. The open question is not whether FDA authorizes AI imaging, but whether S-WAVE™’s data meets the bar; that is what the testing plan is for.
Statistics compiled from the FDA AI-enabled medical device list as reported by industry trackers (PharmaDossier, Innolitics), through December 2025; counts differ slightly between trackers. Precedent devices are not KronosMD products.
What FDA will ask of S-WAVE™
The evidence a home-use imaging device needs
Safety
Acoustic output within diagnostic ultrasound limits; biocompatibility of the tray and couplant; electrical safety of the wired dongle.
Performance
Imaging accuracy against reference imaging; AI standalone performance; clinical accuracy in people.
Usability
Human-factors validation showing lay users can seat the tray and obtain usable scans without training.
Software
IEC 62304 lifecycle, cybersecurity, and a change control plan for AI updates.
Labeling
Indications limited to imaging and monitoring with dentist review; no diagnostic or therapeutic claims.
Quality system
Design controls and manufacturing under FDA’s Quality Management System Regulation.
Dental imaging without radiation, from home.
Questions about S-WAVE™, the research or a collaboration? Our team is here to help.