Evidence First.
Our first-in-human study confirmed 100% specificity for durable PFA lesion prediction at three-month follow-up. Peer-reviewed, published, and ready for the next phase.
Endpoints, statistical analysis plan, and agreement analysis versus reference methods are described in the peer-reviewed publication and registry record. Full protocol and analysis artifacts are available in the data room under NDA.
Clinical Validation
What leading electrophysiologists are saying
Principal Investigator of the AblaView® first-in-human study. Presented the 100% durable PFA specificity result at the AF Symposium, January 2025. Lead author on the peer-reviewed Europace publication, February 2025.
Pioneered remote magnetic navigation. First fully remote catheter ablation globally in 2003. Research lead in EP at Royal Brompton, 200+ publications. Clinical advisor on the AblaView® first-in-human study.
Lead author on the AblaView® PS-OCR preclinical study published in Circulation, 2024. Directs the Preclinical Cardiovascular Lab at Sunnybrook. Specialist in preclinical evaluation of novel ablation devices.
Lesion Durability Prediction
Comparative accuracy in predicting chronic lesion durability at 3-month remap
AblaView® specificity for durable PFA lesion prediction at three-month follow-up reported in Europace, February 2025. Force and impedance comparators are indicative ranges drawn from the published literature on chronic lesion durability.
Artifacts, not aspirations.
Each workstream is mapped to an international standard, a current status, and a referenced evidence artifact available in the data room.
| Workstream | Standard / Pathway | Status | Evidence |
|---|---|---|---|
| Quality Management System | Medical device QMS, international standard | Certified | Certificate (registrar & number in data room) |
| Risk Management | Medical device risk file, international standard | Complete, rev 4 | Risk file & DHF TOC |
| Software Lifecycle | IEC 62304 Class C | Through V&V | Traceability matrix |
| AI / SaMD | IMDRF SaMD Cat III + FDA GMLP | PCCP drafted | SaMD datasheet |
| Electrical Safety | IEC 60601-1 / 60601-2-27 | Tested | Accredited test lab report |
| Biocompatibility | Cytotoxicity, sensitization, irritation panels | Complete | GLP lab reports |
| Usability Engineering | IEC 62366-1 | Formative done • summative Q3 2026 | HF protocol & URS |
| Cybersecurity | FDA 2023 premarket + EU MDR Art. 15(5) | SBOM + threat model | Vuln disclosure policy |
| EU MDR Notified Body | Regulation (EU) 2017/745 Class IIb | NB engaged | NB identity under NDA |
| FDA Pathway, AI Engine | 510(k) with PCCP | Predicate analysis complete | Submission Q3 2026. Target clearance Q4 2026. |
| Pivotal Path | IDE trial, PMA, CE Mark (US and EU sites) | IDE protocol in development | IDE approval target Q2 2028. Commercial launch 2030. |
AblaView® follows a staged rollout. Advisory mode (AI outputs shown to the clinician who retains decision authority) applies through the pivotal trial and initial market clearance. Expanded-claim labeling is pursued only after prospective real-world performance meets the pre-specified PCCP bounds. This mirrors the FDA-favored approach for Class II SaMD with a PCCP and keeps regulatory risk bounded at every stage.
On the record.
Peer-reviewed papers, preprints, conference abstracts, posters, and white papers. Reprint requests honoured within publisher policy.
Peer-Reviewed Publications
Conference Abstracts & Posters
White Papers & Technical Briefs
Access the Full Data Package
Qualified investors and clinical partners can request access to the complete trial dataset, regulatory dossier, and IP portfolio.
Request Data Room Access