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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 / DEN250057

510(k) cleared

PCWP Analysis Software

Cardiosense, Inc. · May 22, 2026 · DEN250057 · In the directory

FDA cleared the PCWP Analysis Software from Cardiosense, Inc. on May 22, 2026 under DEN250057, a direct 510(k). The device falls under product code SIF, Software Device System For Estimation Of Cardiac Pressures, regulated at 21 CFR 870.1150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 17, 2025. The decision came 186 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under DEN250057?

DEN250057 is the FDA 510(k) for PCWP Analysis Software, submitted by Cardiosense, Inc.. FDA's decision date was May 22, 2026, under product code SIF (Software Device System For Estimation Of Cardiac Pressures).

Who makes the PCWP Analysis Software?

Cardiosense, Inc., based in Chicago, IL, is the applicant of record for DEN250057. The company is listed in the MedDevice Startups directory.

How long did the DEN250057 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on May 22, 2026, 186 days later.

← All decisions in May 2026