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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 / May 2026 / P250027

PMA approved

Guardant360® Liquid CDx

Guardant Health, Inc. · May 19, 2026 · P250027

FDA approved the Guardant360® Liquid CDx from Guardant Health, Inc. on May 19, 2026 under P250027, 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 Pathology.

FDA logged the submission as received on Jul 31, 2025. The decision came 292 days later.

This is the only decision on file for Guardant Health, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250027?

P250027 is the FDA PMA for Guardant360® Liquid CDx, submitted by Guardant Health, Inc.. FDA's decision date was May 19, 2026, under product code PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System).

Who makes the Guardant360® Liquid CDx?

Guardant Health, Inc., based in Redwood City, CA, is the applicant of record for P250027.

How long did the P250027 review take?

FDA received the submission on Jul 31, 2025 and issued its decision on May 19, 2026, 292 days later.

← All decisions in May 2026