When you’re working with health care and medical devices, the technology is often the least of your worries. Navigating certifications, product requirements, and government clearance however… that’s a-whole-nother story.
That’s why it’s huge news that Portland’s SweetSpot Diabetes—a startup that helps folks track data from blood glucose meters regardless of who manufactures the meter—has achieved FDA 510(k) clearance for their service.
What’s FDA Section 510(k) you ask?
Section 510(k)… known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.
It’s a milestone for the company. And clears a hurdle that allows more folks to have access to their services.
“We spoke to many patients and health care providers to develop this service,” said Christopher Logan, Chief Executive Officer of SweetSpot Diabetes Care, Inc. “Patients want something that works with all their devices that’s as easy as an ATM. Health care providers want technology sophisticated enough that it’s almost invisible—reports show up where and when they are needed and the data flow is fully automated. With the SweetSpot Diabetes Data Management Service more clinics will gain the benefit of comprehensive analysis of patient blood glucose data. We are thrilled to be cleared to market this to clinics.”