Having achieved CE Mark for sales in Europe and the UK, ThinkSono is now collaborating with Clarius on clinical studies in the United States to prepare for FDA submission
VANCOUVER, BC, April 5, 2024 /PRNewswire/ — Clarius Mobile Health, a leading provider of high-definition handheld ultrasound systems, and ThinkSono, a pioneering medical technology company specializing in ultrasound artificial intelligence (AI) guidance solutions, are introducing a new AI-guided ultrasound system in Europe, which will improve the efficiency of detecting deep vein thrombosis (DVT). ThinkSono Guidance, an AI App that pairs with Clarius ultrasound scanners, recently attained Class llb CE mark regulatory approval.
DVT is a blood clot found commonly in the leg and is a leading cause of preventable hospital death in Europe and the United States. Patients often wait for hours or days for test results performed by ultrasound-trained clinicians. ThinkSono Guidance enables non-ultrasound trained healthcare professionals to use the Clarius handheld ultrasound scanner to collect DVT exam data for a qualified clinician to review. This can speed up the diagnosis from several hours to as little as 15 minutes.
“Clarius has been an invaluable partner in helping us bring ThinkSono Guidance to market quickly to help non-ultrasound trained staff such as nurses improve the DVT pathway by scanning for DVTs at the bedside,” says Fouad-Al Noor, CEO and Co-founder of ThinkSono. “Our App integrates seamlessly with Clarius scanners through the research SDK, which sends streams of real-time data to the ThinkSono App that in turn providing instant guidance to users as they perform an ultrasound exam. Our partnership with Clarius has been vital in running our clinical studies.”
Further clinical studies are currently underway in the United States at NYU Longone Health and Temple Health, these are based on the successful multi-site clinical trials held in Europe last year, which were used to obtain the Class IIb CE mark for the ThinkSono Guidance System.
ThinkSono purchased their first Clarius scanner in 2017 and were the first partner to use the Clarius Cast API, developed for researchers and AI companies to help bring technologies to market more quickly by leveraging easy access to real-time ultrasound data to train AI algorithms and deploy AI solutions. ThinkSono now uses Clarius’ Solum software development kit (SDK), enabling the company to create a bespoke solution tailored to their DVT application. ThinkSono will be marketing and selling the complete DVT solution including a Clarius ultrasound scanner directly starting in the UK, Germany and Greece.
“Working closely with ThinkSono since the inception of their company, when they utilized our first-generation high-performance scanners, has been a delight,” says Kris Dickie, Chief Technology Officer at Clarius. “Seeing unique AI tools like theirs being developed for commercial use on our platform truly validates the technology beyond the already broad clinical segments that Clarius currently serves.”
The Clarius SDK suite empowers third party developers to seamlessly integrate AI-powered ultrasound software with Clarius handheld ultrasound systems, the Clarius App, and the Clarius Cloud exam management platform. It provides a set of tools enabling developers to quickly take their solution from code directly to the clinician’s hand without creating custom hardware.
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 4 million high-definition scans have been performed using Clarius wireless handheld scanners. Clarius scanners are available in over 90 countries worldwide. Learn more at www.clarius.com.
Clarius Media Contact
Marie-Claire Charlton
Director of Marketing
[email protected]
Phone: +1 (778) 800-99754 ext. 148
About ThinkSono
ThinkSono has developed the world’s first real-time Ultrasound AI software to enable non-ultrasound healthcare staff to perform DVT scans. This technology addresses the worldwide unmet medical need for better DVT detection.
With several patents granted and multiple peer-reviewed papers published in prominent journals such as Nature Digital Medicine, ThinkSono has demonstrated its leadership in the Ultrasound AI space. The company aims to enable any healthcare professional to use the power of ultrasound and increase the universal access to ultrasound imaging.
ThinkSono Media Contact
Email: [email protected]
Regulatory information
Refer to the electronic Instructions for Use which contain the regulatory classification (Class IIb) and intended purpose of ThinkSono Guidance in the EU in accordance with Regulation (EU) 2017/745: www.thinksono.com/ifu
ThinkSono Guidance is not FDA cleared, and thus will not be available in the U.S until full clearance is obtained. Please contact [email protected] for more information on the ThinkSono Guidance System.
SOURCE Clarius Mobile Health
