India, Sept. 1 -- Ypsomed Holding AG (YPHDF) announced Monday that its digital connectivity add-on, SmartPilot, has received 510(k) clearance from the U.S. Food and Drug Administration or FDA.
SmartPilot captures key injection data, such as time and date, injection outcome, and potential user errors, and transmits it securely via Bluetooth to patients' smartphones. SmartPilot detects and identifies user errors and logs all relevant injection data, helping improve the safety and reliability of self-injection.
With automatic and real-time data collection, the device supports both clinical development and day-to-day therapy management.
The company noted that SmartPilot is the first and only FDA-cleared connectivity device specifically desig...