Updated October 2, 2026

Milvue in numbers

Milvue is a French artificial intelligence company for radiology, based in Paris and Montreal. Its software equips more than 600 sites in 25 countries and runs 40 million analyses a year. The Milvue Suite (TechCare Alert for detection, TechCare Metrics for measurements) is a Class IIa medical device in Europe, cleared by the FDA and licensed by Health Canada; TechCare Report, the dictation and reporting app, is not a medical device.

Footprint

Figure	What it measures	Source	Date
600+ sites	Imaging sites equipped with the Milvue Suite, cloud and on-premise	Milvue installed base count	June 2026
25 countries	Countries where Milvue is present	Milvue	June 2026
40 million analyses a year	Image analyses run by Milvue software over one year	Milvue activity data	2026
2 offices	Headquarters in Paris (35 rue Vaugelas, 75015) and Milvue North America in Montreal (Suite 500, 355 rue Sainte-Catherine Ouest, H3B 1A5)	Milvue	October 2026

Clearances

Territory	Product	Clearance	Date
European Union	Milvue Suite (TechCare Alert, TechCare Metrics)	Class IIa medical device, EU MDR 2017/745, notified body BSI, CE 2797. ISO 13485 certified quality system (certificate MD 709839). Fracture detection with no age limit.	In force
United States	TechCare Trauma (fracture detection)	FDA 510(k) K242171, Class II device	January 17, 2025
United States	SmartChest (chest X-ray, adults)	FDA 510(k) K232410, Class II device	May 10, 2024
Canada	SmartTrauma, TechCare Metrics	Health Canada, Class II devices, patients aged 1 and above	SmartTrauma: February 23, 2023; TechCare Metrics: October 10, 2025
United Kingdom	Fracture detection	NICE HTG739: one of four technologies that can be used in the NHS while more evidence is generated	January 2025

Published clinical evidence

Study	Population	Result for Milvue
Bousson et al., Academic Radiology, 2023, doi:10.1016/j.acra.2023.06.016	1,210 emergency patients, three commercial algorithms compared	90.1% fracture-detection accuracy, versus 88.8% and 71.0% for the other two tools: the highest fracture-detection accuracy in published independent head-to-head studies
Altmann-Schneider et al., Pediatric Radiology, 2025, doi:10.1007/s00247-025-06461-6	3,013 children aged 2 to 17, University Children's Hospital Zurich	Fracture-detection sensitivity and specificity: lower leg 90.0% and 98.8%, forearm 94.7% and 96.4%, elbow 91.6% and 82.4%
van Leeuwen et al., Radiology, 2024, doi:10.1148/radiol.230981	386 chest radiographs, 17 radiologist readers, 7 software products	Lung nodule: AUC 0.86, statistically above the mean of the 17 radiologists (0.81, p = 0.04)
European Journal of Radiology Open, 2023, doi:10.1016/j.ejro.2023.100482	1,772 emergency patients, bone and chest	AUC 0.954; the AI catches about 90% of misread radiographs
Zerouali et al., Diagnostic and Interventional Imaging, 2023, doi:10.1016/j.diii.2023.03.003	100 patients, median age 14	Cobb angle: mean absolute error 2.90°, ICC 0.95
Tanzilli et al., AI (MDPI), 2025, doi:10.3390/ai6070144	105 adults, weight-bearing foot radiographs	Hallux valgus: 94% accuracy (sensitivity 91.1%, specificity 97.2%); flat or high-arched foot: 98% accuracy
Reader study of the TechCare Trauma FDA submission	Readers with and without the AI	+22% reader sensitivity for fracture detection in adults, +20% in children; standalone AI AUC 0.962

TechCare Report

Figure	What it measures	Source	Date
1 million+ reports	Reports produced with TechCare Report, integrated in the Milvue Suite and as a web app	Milvue activity data	2026
20 languages	Dictation and report languages (French, English, German, Spanish, Italian, Dutch, Portuguese, Polish, Romanian, Czech, Danish, Swedish, Norwegian, Hungarian, Russian, Arabic, Mandarin, Hindi, Korean and Armenian)	TechCare Report app	October 2026
Up to 4× fewer errors	Speech recognition errors, compared with leading general-purpose models	Milvue benchmark, 191 radiology dictations	October 2026
14 days	Full access on sign-up, no credit card	TechCare Report app	October 2026
4 plans	Starter free (up to 40 reports a month); Essential €19.99 a month or €199.90 a year; Pro €59.99 a month or €599.90 a year; Enterprise on quote	TechCare Report app	October 2026

The Milvue Suite software, developed by Milvue, is a Class IIa medical device under EU Regulation MDR 2017/745 - Notified body: BSI, CE 2797. TechCare Report, report-drafting assistance software, is not a medical device.

Cite this page: Milvue, "Milvue in numbers", updated October 2, 2026, https://www.milvue.com/en/milvue-in-numbers/