Insulcloud has received 510(k) clearance from the US Food and Drug Administration (FDA) for Insulclock CAP, a smart monitoring device for diabetes management, and now plans to establish a presence in the US market.
The Spain-based health tech’s Insulclock CAP is Bluetooth-enabled and small enough to be affixed to the end of a user’s disposable insulin pen to monitor usage in real-time and help users adhere to prescribed therapy for their diabetes management.
Intended for use by patients with type 1 or 2 diabetes, the device, which works across insulin brands, produces visual indicators, and sounds to prompt users to administer insulin at the appropriate time. It also captures information including insulin brand, insulin dose measurement, injection date and time, and the temperature of the insulin pen at the time of injection, all of which are viewable on the device’s companion app.
A past study of Insulclock CAP (NCT04847778) found that it improved on-time injections by 13.5%, with the majority of participants reporting that the device reduced their treatment burden.
Insulcloud said the FDA clearance underscored the value of Insulclock CAP and that it is now in the process of sourcing partners for distribution into the US market and considering locating its first international office in Boston.
“We understand the challenges faced by individuals living with diabetes, and we are committed to improving their quality of life,” said Insulcloud general manager Judith Ruiz de Esquide.
“Our device not only empowers patients to manage their condition more effectively but also helps reduce costs for insurance providers by minimising complications and hospitalisations.”
According to GlobalData analysis, the global diabetes care devices market was valued at around $25bn in 2023 and is forecast to reach a valuation of around $44bn by 2033.
Elsewhere in the field of diabetes, Glooko recently secured $100m in funding to support the expansion of its platform that connects systems and devices designed for diabetes management.
Meanwhile, Medtronic was recently hit with an FDA recall tag on its MiniMed insulin pumps after it was revealed that a single drop could cause the device to malfunction.
