FDA clears Teratech's Windows tablet-based ultrasound system

By Jonah Comstock
12:33 pm

terasonTeratech Corporation, a Burlington, Massachusetts-based ultrasound equipment supplier, has received FDA 510(k) clearance for a tablet-based ultrasound system. The Terason uSmart 3200T is a five-pound tablet running Windows 7 touch, according to clearance documents.

The device is the first in Teratech's series of uSmart mobile ultrasound devices. Teratech is marketing the unit for emergency medicine, anesthesia, and critical care use. The device has a charging cradle for when it's not in use, or an optional cart for hospital use. It connects to an ultrasound probe via a USB 3.0 port.

"The Teratech Corporation Terason uSmart 3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body," the clearance document says. "Specific clinical applications and exam types include: Fetal, Abdominal, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular."

The tablet has Wifi and Bluetooth connectivity and an 11.5-inch high-resolution monitor. The device's adaptive touch screen is also a color display. It runs a 128 giga-byte processor, boasts a fast boot-up time, and includes features like enhanced needle visualization, smart gestures, and power doppler capabilities. It's integrated lithium-polymer battery allows the device to scan for two hours without needing a charge. The Terason uSmart also secured CE Mark clearance for European markets.

Redmond, Washington-based Mobisante received clearance for a Windows-based tablet ultrasound this past April. That company previously had a smartphone ultrasound cleared. At the time, Mobisante's CTO and co-founder David Zar told MobiHealthNews that the tablet-based system provided a good compromise between the portability of a smartphone ultrasound and the high screen resolution of a traditional stationary ultrasound machine.

Aside from Mobisante, the other big name in FDA-cleared handheld ultrasound technology is GE's VScan, a dedicated, pocket-sized device often championed by Scripps Health cardiologist and digital health evangelist Dr. Eric Topol.

The company's demo video, below, shows the device's touch-screen user interface in action.


For an in-depth analysis of tablet use cases in healthcare, including FDA clearance and medical imaging, pick up a copy of the MobiHealthNews tablet report.

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(Image: "1 US Bank Note"/geralt via Pixabay, licensed under Creative Commons Zero)

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