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THE TAPE

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 / DEN250042

510(k) cleared

CaRi-Heart

Caristo Diagnostics , Ltd. · Jul 28, 2026 · DEN250042 · In the directory

FDA cleared the CaRi-Heart from Caristo Diagnostics , Ltd. on Jul 28, 2026 under DEN250042, a direct 510(k). The device falls under product code SIU, Predictive Indicator For Long-Term Cardiovascular Outcomes, regulated at 21 CFR 870.2215 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 4, 2025. The decision came 327 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 Caristo Diagnostics , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250042?

DEN250042 is the FDA 510(k) for CaRi-Heart, submitted by Caristo Diagnostics , Ltd.. FDA's decision date was Jul 28, 2026, under product code SIU (Predictive Indicator For Long-Term Cardiovascular Outcomes).

Who makes the CaRi-Heart?

Caristo Diagnostics , Ltd., based in Stamford, CT, is the applicant of record for DEN250042. The company is listed in the MedDevice Startups directory.

How long did the DEN250042 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on Jul 28, 2026, 327 days later.

← All decisions in July 2026

Sources

In the startup directory

Caristo Diagnostics

Cardiovascular · Oxford, UK