By Elizabeth Armstrong Moore

Eight months and several hurdles after receiving 510(k) clearance, mobile-health company Mobisante says its smartphone ultrasound device is officially on the market.

The MobiUS system is on the market for $7,495.

(Credit:

Mobisante)

The U.S. Food and Drug Administration clearance alone took so long that the MobiUS system--intended to be used in fetal, abdominal, cardiac, pelvic, and peripheral vessel imaging--only works with the 2-year-old Windows Mobile 6.5-based Toshiba TG01 smartphone and requires a USB 2.0 port for the probe. In other words, it won't be compatible with iPhones and Android-based phones, which don't support USB 2.0.

Still, the device, which, at $7,495, is comparable to its main competitor, GE's Vscan, pushes the envelope for ultrasound systems, which can cost upward of $100,000. (GE's solution is also mobile, but it does not use a wirelessly connected handheld device.)

Mobisante co-founder David Zar tells MobiHealthNews that the MobiUS, which is 5.1 inches by 2.75 inches and weighs just over 11 ounces, isn't necessarily a replacement for most systems. But for smaller clinics, the full imaging solution might make ultrasound systems far more affordable.

Now that the system is finally hitting the shelves, Zar says the company is looking to update device compatibility with a tablet-based solution. "Our work has just begun, really," he says.

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3 Comments

1. 1. JemArusMom 12:53 AM 10/12/11

   A word of caution please! Ultrasounds have not been rigorously studied for effects on the newborn and there have been some studies showing links of ultrasounds to higher incidences of autism in the newborn. Please excercise caution and use ultrasounds *only* if recommended by the doctor and medically necessary.

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2. 2. lynchoid 02:42 PM 10/12/11

   A 2006 study found that sustained exposure of mouse embryos to ultrasound waves caused a small but statistically significant number of neurons to fail to acquire their proper position during neuronal migration. It is highly unlikely that this result speaks directly to risks of fetal ultrasound as practiced in competent and responsible medical centers. There is no scientific evidence of an association between prenatal ultrasound exposure and autism, but there are very little data on human fetal exposure during diagnostic ultrasound, and the lack of recent epidemiological research and human data in the field has been called "appalling".
   
   Ang ES Jr, Gluncic V, Duque A, Schafer ME, Rakic P. Prenatal exposure to ultrasound waves impacts neuronal migration in mice. Proc Natl Acad Sci USA. 2006;103(34):12903–10. doi:10.1073/pnas.0605294103. PMID 16901978. PMC 1538990
   
   Abramowicz JS. Prenatal exposure to ultrasound waves: is there a risk?. Ultrasound Obstet Gynecol. 2007;29(4):363–7. doi:10.1002/uog.3983. PMID 17352453
   
   Interesting, though inconclusive experiment. Unless you have mice-children.

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3. 3. lynchoid 02:44 PM 10/12/11

   http://www.pnas.org/content/103/34/12903.full

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