Clarius Mobile Health Announces Historic 2025: Achieves Profitability, Double-Digit Growth, and New FDA Clearances for Ultrasound AI

VANCOUVER, BC, Dec. 17, 2025 /PRNewswire/ -- Clarius Mobile Health, a global leader in AI-powered handheld ultrasound, today announced a record year for the company, driven by achieving profitability in FY2025 and securing 20% year-over-year revenue growth. The milestone validates the company's strategic business model transformation and positions Clarius as a sustainable leader in the competitive medical imaging market.

"2025 has been a pivotal year where our commitment to evidence-based clinical innovation was converged with rigorous operational execution," said Clarius CEO Laurent Pelissier. "Achieving profitability while simultaneously launching FDA-cleared AI models demonstrates that Clarius is not just growing, we are securing the future of handheld ultrasound, ensuring its long-term viability and the continued expansion of medical imaging."

Leadership in AI and Clinical Validation
With the introduction of 2 new FDA-cleared AI models available in the Clarius ultrasound App in 2025 bringing the total number of FDA-cleared models to 6 and deployed AI technologies to 16. Clarius cemented its position as an AI leader in the Point-of-Care Ultrasound (POCUS) space this year. Clarius Prostate AI uses artificial intelligence to automatically identify the prostate and perform measurements to calculate prostate volume and PSA Density for urological assessments. Clarius Median Nerve AI, helps to locate and measure the median nerve during Carpal Tunnel Syndrome assessments. There are now sixteen AI models deployed across education, diagnostic, and workflow applications.

Global Recognition and Expansion
The company's innovation in medical imaging was recognized globally when Clarius was named one of TIME's "World's Top HealthTech Companies of 2025," earning a top ranking in the Medical Devices & Wearables category.

On the international front, Clarius expanded its distribution network to serve more than 70 countries and doubled growth in the Indo-Pacific region. Clarius was one of only eight companies nationwide selected for Canada's Global Hypergrowth Program.

Pharmaceutical Partnerships 
Clarius expanded its B2B ecosystem and opened new revenue streams by establishing its ultrasound scanners as a proven tool for evidence-based innovation in drug development and patient care. The company launched strategic collaborations with leading pharmaceutical companies and Contract Research Organizations (CROs) to validate handheld ultrasound in rigorous clinical trials.

Product Innovation and Strategic Partnerships
The company released more than 60 new features across four major software updates in 2025, including expanded T-Mode™ capabilities for breast, shoulder, and abdominal scanning, and Auto Preset AI for veterinary medicine.

Clarius also opened new B2B revenue streams by partnering with leading pharmaceutical companies and Contract Research Organizations (CROs) to validate handheld ultrasound technology in clinical trials, establishing its scanners as proven tools for drug development and patient care.

Community Engagement & Education
The company participated in more than 80 medical tradeshows globally and hosted 15 clinical webinars for healthcare professionals. Clarius expanded its education partner network to 29 organizations worldwide, reinforcing its commitment to advancing ultrasound education and accessibility.

Looking Ahead
With profitability achieved and momentum accelerating into 2026, Clarius is focused on expanding its AI capabilities, deepening partnerships, and bringing affordable, easy to use, high-quality ultrasound technology to more healthcare providers worldwide.

About Clarius Mobile Health 
Clarius is on a mission to make accurate, easy-to-use, and affordable ultrasound tools available to all medical professionals in every specialty. With decades of experience in medical imaging, the team knows that great ultrasound imaging improves confidence and patient care. Today, AI-powered Clarius handheld wireless ultrasound scanners connect to iOS and Android devices, delivering high-resolution ultrasound images traditionally only available with bulkier, high-end systems at a fraction of the cost. Almost 7 million high-definition scans have been performed using Clarius wireless handheld scanners. Clarius scanners are available in over 70 countries worldwide. Learn more at www.clarius.com. 

Clarius Media Contact 
Sarah Leverett
Vice President of Marketing | Clarius Mobile Health
Phone: +1 (206) 550-6120
Email: [email protected] 

SOURCE Clarius Mobile Health