Butterfly Network, maker of a handheld, smartphone-connected ultrasound system, has disabled two software features that were implemented on its devices without first securing 510(k) clearance, according to notices recently published by the FDA.
The Auto Ejection Fraction Tool and the Auto Bladder Volume Tool were introduced in the Butterfly IQ Ultrasound System's 1.10.0 and 1.13.0 software...
New York City and Guilford, Connecticut-based Butterfly IQ has received FDA clearance for an iPhone-connected portable ultrasound scanner that uses an easy-to-manufacture semiconductor chip rather than the piezoelectric crystals used by traditional ultrasounds.
Because of the semiconductor chip, the device will be offered at a much lower price point than existing ultrasounds, including existing...
Telemedicine seems to have been swept up in the contentious abortion debate, as Texas has effectively banned the remote prescribing of "abortion pills" and several states are considering similar restrictions. But some proposed legislation may have the side effect of curtailing telemedicine in many other, less-controversial cases, while mobile technologies may provide a means of getting around the...
In February Mobisante announced that the FDA had cleared its handheld, smartphone-enabled ultrasound offering, and while the company hoped to launch "a long time ago," MobiUS only just became commercially available in recent days, Mobisante co-founder and CTO David Zar told MobiHealthNews.
Since it received its 510(k) clearance eight months ago, Mobisante has been working to put its quality...
A steady procession of mobile health devices continues to march through the FDA's regulatory process.
The US Food and Drug Administration has granted Redmond, Washington-based mobile health start-up Mobisante 510(k) clearance for its smartphone-based ultrasound system, MobiUS.
Dr. Sailesh Chutani, CEO and co-Founder of Mobisante, was previously an executive at Microsoft. Before founding Mobisante...
