MAUI's 510K FDA clearance:

In October 2023, MAUI K3900 received its 510K FDA Clearance and is now available for commercial use. Because MAUI's technology differs from existing imaging ultrasound technologies, MAUI was required to conduct comparative image testing proving it can effectively image with a simple probe. No other recently cleared ultrasound systems have been required to do this, thus demonstrating the unique and powerful potential for this patented imaging technology.


The MAUI K3900 Ultrasound Imaging System is intended for use by qualified healthcare personnel in environments where healthcare is provided for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); and Intraoperative (abdominal, thoracic and vascular). Examples of differentiating images for use in trauma, neurosurgery and interventional radiology can be found at mauiimaging.com/solutions.

MAUI's Patented Computed Echo Tomography (CET):

MAUI Imaging has created a novel and effective approach to medical imaging that provides views that look like a cross between ultrasound and CT without the need for dangerous ionizing radiation (x-rays). MAUI's CET pings the designated part of the human body, uniquely seeing anatomy beyond what other ultrasound systems can see. MAUI then uses proprietary patented algorithms to accommodate the reflected energy from various flight paths and sums up the data to create a reliable image of all the structures below the probe. Barriers such as bone, gas, fat, instruments, implants, etc. are intended to become part of the image instead of obstacles to image formation. MAUI is performing clinical studies with the military and elsewhere to fully demonstrate these capabilities.

MAUI's core patents deal with solving for speed-of-sound issues in tissue, enabling views of a variety of tissue types, including lung and cranium, previously thought to be unobtainable. MAUI's portfolio is believed to be one of the strongest imaging patent portfolios with more than 160 granted patents and dozens more pending in and outside the U.S.

MAUI uses a concave probe that fires pulses into the tissue from many different angles. The MAUI probe's concave shape sends and receives energy from multiple angles, one of the reasons allowing MAUI to see through and around barriers. This is something no other known ultrasound-based system can accomplish. MAUI's probe can also be much larger as it does not need to navigate between barriers, such as the ribs, making it more easily positioned over regions of interest. In addition to enabling clinicians to see beyond barriers without requiring more invasive imaging approaches, typically, a highly trained sonographer technician or physician is required to get images around the ribs and aim at what they want. With MAUI, the user doesn't have to worry about the ribs or perfect placement of the probe making medical imaging ubiquitous.

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