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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 / P250029

PMA approved

SimpleScreen CRC

Freenome, LLC · Jul 24, 2026 · P250029 · In the directory

FDA approved the SimpleScreen CRC from Freenome, LLC on Jul 24, 2026 under P250029, an original premarket approval. The device falls under product code PHP, System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection as a Class 3 device. The review panel was Medical Genetics.

FDA logged the submission as received on Aug 1, 2025. The decision came 357 days later.

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

Questions & Answers

What did FDA approve under P250029?

P250029 is the FDA PMA for SimpleScreen CRC, submitted by Freenome, LLC. FDA's decision date was Jul 24, 2026, under product code PHP (System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection).

Who makes the SimpleScreen CRC?

Freenome, LLC, based in Brisbane, CA, is the applicant of record for P250029. The company is listed in the MedDevice Startups directory.

How long did the P250029 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Jul 24, 2026, 357 days later.

← All decisions in July 2026