The Signos, Self Contained Handheld Ultrasound Gains FDA Approval

While we have reported on mobile handheld ultrasounds for phones, for those of you that have not joined the iPhone/Smartphone revolution, you are now in luck. The Food and Drug Administration (FDA) has just approved the Signos device, a handheld self-contained portable ultrasound imager with a probe. The system might come in handy as a quick initial diagnostic modality for intraabdominal processes, such as ectopics, AAAs, for carotid scans in ER in patients with ongoing TIA, as well as an assistive device for central line placements. For now, the system seems to be missing a Doppler for flow studies.
The Signos weighs half of a pound and is the size of most smartphones. It will be available with both a 3.5MHz or a 7.5MHz transducer that can be swapped. The company promotes this device for fast paced and active medical environments such as emergency departments and rural medical clinics.

Portable and Affordable: The Signos device is the size of a PDA, weighs less than one pound and features superb image resolution. The Signos is the world’s smallest and most affordable ultrasound system available today.
Signos Is Ready When You Need It: With a sleep time of up to 14 days and the ability to power up in less than 1 second from sleep mode, the Signos brings ultrasound to your triage diagnostic care whenever and wherever you need it allowing you to visualize acute pathology on the spot.
Increase Clinical Utility with Added Versatility and Applications: Increase the number of procedures and applications you can perform with either a 3.5MHz or a 7.5MHz transducer. Signostics makes switching from 3.5MHz to 7.5MHz frequencies simple with our easy to use screw on/off transducers.
See More, Do More with MotionScape and SectorView Technology: Signos uses MotionScape and SectorView technology to facilitate a wide range of high resolution clinical applications, including ultrasound guidance for needle placement, AAA exams, FAST exams, bladder volumes and more.
Image Collection: Using the included microSD card you can save up to 20,000 images on the Signos device. With the free SigViewer Software you can quickly and easily upload data and images to your computer for reports, archiving, printing or email.

Signostics Medical has not disclosed a price point or time line for for the Signos release as of yet, but their video support for the device indicates that this is something that is very close to being ready for commercialization.

Press release: Signostics Receives FDA Clearance for World’s Smallest Ultrasound Product…
Product page: The Signos device…; Product brochure (.pdf)…
Signostics Medical: Signos
Flashback : Mobile Clinical Imaging On a Smart Phone