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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 / July 2026 / P250036

PMA approved

PGDx elio tissue complete CDx

Personal Genome Diagnostics, Inc. · Jul 30, 2026 · P250036

FDA approved the PGDx elio tissue complete CDx from Personal Genome Diagnostics, Inc. on Jul 30, 2026 under P250036, an original premarket approval. The device falls under product code PQP, Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System as a Class 3 device. The review panel was Medical Genetics.

FDA logged the submission as received on Sep 10, 2025. The decision came 323 days later.

This is the only decision on file for Personal Genome Diagnostics, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250036?

P250036 is the FDA PMA for PGDx elio tissue complete CDx, submitted by Personal Genome Diagnostics, Inc.. FDA's decision date was Jul 30, 2026, under product code PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System).

Who makes the PGDx elio tissue complete CDx?

Personal Genome Diagnostics, Inc., based in Blatimore, MD, is the applicant of record for P250036.

How long did the P250036 review take?

FDA received the submission on Sep 10, 2025 and issued its decision on Jul 30, 2026, 323 days later.

← All decisions in July 2026