A public status snapshot covering each Perspectum biomarker and product across FDA, EMA, MHRA, UKCA and CE Mark, refreshed quarterly. Pending items are listed as pending.
A public status snapshot, refreshed quarterly. Pending items are listed as pending; cleared items are named with the cleared pathway. The fuller evidence position lives inside the claims matrix governed by Regulatory Affairs and Translational Science.
| Biomarker / Product | FDA | EMA | MHRA / UKCA | CE / EU MDR |
|---|---|---|---|---|
| LiverMultiScan (cT1, PDFF, T2*) | 510(k) cleared | Scientific advice engaged | UKCA · MHRA registered | CE Mark, Class IIa |
| cT1 as endpoint biomarker | BQP submission active (DDT-COA) | Qualification pathway, pending | Recognised in trial submissions | , |
| CoverScan (multi-organ MRI) | 510(k) cleared | , | UKCA · MHRA registered | CE Mark, Class IIa |
| MRCP+ (biliary tree) | 510(k) cleared | , | UKCA · MHRA registered | CE Mark, Class IIa |
| Hepatica (pre-op planning) | 510(k) cleared | , | UKCA · MHRA registered | CE Mark, Class IIa |
| PAIR (Perspectum AI Reader) (AI pathology; digital endoscopy on roadmap) | Pre-market · DDT-COA in preparation | Pre-engagement | SaMD pathway in preparation | Pre-market |
Last reviewed May 2026. Status descriptors are simplified for the buyer-facing view; the canonical position is maintained in the Regulatory Affairs claims matrix and reflected in product instructions for use. For a current regulatory dossier, contact our pharma team.
How the table above is built and maintained.
Biomarker or product, FDA pathway position, EMA scientific advice, MHRA SaMD pathway, UKCA, CE Mark class. One row per biomarker. Source: Brand Review v2 A.7.
FDA Letter of Intent acceptance positions LiverMultiScan-cT1 as Reasonably Likely Surrogate Endpoint in MASH trials. The single most material future regulatory inflection on the platform. Owner: Regulatory Affairs.
LOI in submission / accepted / pending. Approval target year, not actual approval. Same convention used throughout the site. Owner: Regulatory Affairs + Translational Science.
DDT-COA submission in preparation, EMA pre-engagement, MHRA SaMD pathway opened. Update as status changes. Source: Brand Review v2 A.6 and 6.4.
Every entry on this table corresponds to a row in the live claims matrix (Section 8.1). Wording changes here only after Regulatory Affairs updates the matrix row.
Reviewed when any cited product's regulatory status changes; baseline quarterly audit by Regulatory Affairs. Source: Section 8.1.
This page is currently in development. The outline above shows what it will cover, with content owners noted on each card.
If you own one of the source items above, the fastest way to convert this placeholder into a live page is to drop the draft content into the Brand Review v2 doc under the matching section.
Speak to the team