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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / P250031

PMA approved

VENTANA PTEN (SP218) RxDx Assay

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Jun 12, 2026 · P250031

FDA approved the VENTANA PTEN (SP218) RxDx Assay from Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) on Jun 12, 2026 under P250031, an original premarket approval. The review panel was Pathology.

FDA logged the submission as received on Aug 18, 2025. The decision came 298 days later.

This is the only decision on file for Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250031?

P250031 is the FDA PMA for VENTANA PTEN (SP218) RxDx Assay, submitted by Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). FDA's decision date was Jun 12, 2026, under product code SHF.

Who makes the VENTANA PTEN (SP218) RxDx Assay?

Ventana Medical Systems, Inc. (Roche Tissue Diagnostics), based in Tucson, AZ, is the applicant of record for P250031.

How long did the P250031 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Jun 12, 2026, 298 days later.

← All decisions in June 2026