Julie M. Donnelly, Health Care reporter for the Boston Business Journal, wrote a recent article about the scrutiny mobile health IT firms face from the FDA. GeckoCap was featured in this article which discussed the impending obstacles it will need to overcome on its pathway to regulation and production.
“Their technology, GeckoCap, combines a device attached to an asthma inhaler with software that transmits usage data to the smartphone of a young patient’s parent or doctor, to drive consistent usage. The duo has raised about $100,000, some of it on a crowdfunding website. Their public presence on the site, and resulting media attention, prompted calls from the U.S. Food and Drug Administration.”
“Two years after the FDA issued draft guidance on mobile health technology, the agency is suddenly taking a greater interest in following through. Late last month, the FDA launched its first mobile health IT inquiry, into India-based Biosense Technologies’ uChek system, which uses software to analyze urine test strips by taking a photo of the strips with a smartphone. The FDA inquiry has sent a ripple of concern throughout the industry.”
“New regulations on previously unregulated mobile health apps would add significant time to market, and could spook investors. The FDA is now expected to issue final guidance this fall that would clarify which mobile health IT products would fall under existing regulations.”
“‘We are talking to investors and they are looking to mitigate risk,’ Maalouf said. ‘We have enough risk as an early stage company, without adding a long regulatory process.’”
“While GeckoCap always expected the device-software combination to be regulated, they’d hoped to sell the software by itself earlier, to raise some cash and the company’s profile. Engelhard and Maalouf believe that because GeckoCap merely helps patients self-treat their condition, rather than diagnose it, the software should not be regulated under the current guidelines. But because doctors could use the asthma inhaler data to guide treatment, GeckoCap may fall into a gray area that could ensnare a number of local companies.”
Read more here.
Geckocap is a better method to manage your child’s asthma medication. Find out more here