Agitated Solutions Secures CE Mark for Orbis™ Microbubble Generator
Agitated Solutions has secured CE Mark approval in the European Union for its Orbis™ Microbubble Generator, allowing the company to market the device across EU countries.
The approval confirms that the technology meets European safety, health, and environmental standards.
The Orbis™ Microbubble Generator has been developed to improve saline contrast echocardiography procedures, commonly known as bubble studies.
These studies are widely used to diagnose right-to-left cardiac shunts, which can lead to abnormal blood flow and increase the risk of stroke, particularly in younger patients.
Millions of bubble studies are performed globally every year.
Traditionally, clinicians manually mix saline and air to create microbubbles for injection during the procedure. However, this method can produce inconsistent bubble quality, affecting image clarity and diagnostic accuracy. It also typically requires two healthcare professionals to complete the process.
The Orbis™ system is designed to generate controlled microbubble sizes and concentrations to improve ultrasound image quality and provide more consistent results.
The device can also be operated by a single sonographer, helping reduce workload and improve efficiency in echocardiography laboratories.
In the U.S., the company is currently conducting the ENHANCE clinical study (NCT06938347) as part of its preparation for a future regulatory submission to the FDA.
