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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 / P260004

PMA approved

Signatera CDx

Natera, Inc. · May 15, 2026 · P260004

FDA approved the Signatera CDx from Natera, Inc. on May 15, 2026 under P260004, 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 Jan 29, 2026. The decision came 106 days later.

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

Questions & Answers

What did FDA approve under P260004?

P260004 is the FDA PMA for Signatera CDx, submitted by Natera, Inc.. FDA's decision date was May 15, 2026, under product code PQP (Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System).

Who makes the Signatera CDx?

Natera, Inc., based in Austin, TX, is the applicant of record for P260004.

How long did the P260004 review take?

FDA received the submission on Jan 29, 2026 and issued its decision on May 15, 2026, 106 days later.

← All decisions in May 2026