Clarius Mobile Health hopes to launch its new wireless ultrasound scanner by late 2016, assuming it receives the FDA’s 510(k) clearance and complies with Health Canada, CE, and other regional regulations. MedicalExpo e-mag asked Dave Willis*, Clarius Co-Founder and Chief Strategy Officer, to describe the innovative aspects of the new device.
ME e-mag: What sets the Clarius ultrasound scanner apart from other scanners?
Dave Willis: Several features make it stand out in the market. For example, its stellar imaging quality. As far as we know, this is the only wireless scanner that fits in a large pocket. It weighs less than one pound. Therefore, instead of dragging a cumbersome ultrasound cart around, it’s possible to perform a scan anywhere, and without messing with wires.
It also has a rugged magnesium shell that makes the device drop-resistant and fully submersible. We see this as especially valuable in resource-poor domains, such as global public health or emergency medical services. Although the price point is not precise at this time, it will be priced so that several Clarius scanners could be purchased for the price of one traditional cart-based system.
ME e-mag: Where do you see such a portable, wireless device being most useful?
Dave Willis: Ideally, we see this as extremely valuable when you want to take a quick look at a patient. We see it as important for guiding anesthesia nerve blocks, anything musculoskeletal, line placements and emergency care. Also, anywhere that access to computed tomography or MRI is limited, it adds diagnostic information.
It gives you a good quick look and works well for telemedicine applications.
Ultrasound is very sensitive to blood in the abdomen and other parts of the body. We see it as a very useful first look in emergency care. We see it as extremely valuable in areas where access to radiology is poor or there is a long wait for CT or MRI. In remote emergency or trauma situations, a scan can be done and reviewed through a smartphone. It gives you a good quick look and works well for telemedicine applications.
One application that surprised us is obstetrics. But obstetricians told us that often ultrasound rooms are backed up, and that sometimes all that they need is a quick look to see whether the head is up or down, and to check the placenta. Another place that this might prove valuable is in home healthcare, which is replacing hospitalization for some patients.
ME e-mag: Is this device unique?
Dave Willis: As far as we know, we are the first company to launch a wireless device like this. Another company has one, but our image quality is much better.
ME e-mag: How is Clarius addressing concerns about patient privacy and cybersecurity?
Dave Willis: We are using the newest encryption methods and think that our system is more secure than intra-hospital communications. We also are working to comply with HIPAA (the US Health Insurance Portability and Accountability Act). We do not think that Clarius scanners are vulnerable to hacking.
*Erroneously called Dave Wilson in a previous version.