Manufacturers & Products
Market leaders, product lines, and regulatory pathways
ISO 15197:2013 and Regulatory Standards
ISO 15197:2013 is the international accuracy standard for blood glucose meters and test strips used for self-testing. In the US, FDA regulatory review...
Connectivity and Data Standards (Bluetooth/BLE)
Bluetooth Low Energy (BLE) blood glucose meters copy readings to a phone, and two open data standards, the Bluetooth Glucose Profile and IEEE 11073-10...
Counterfeit vs. Generic Strips
Counterfeit test strips copy a brand's packaging but come from an unknown maker with no FDA clearance, while legitimate generic strips, whether store-...
Cybersecurity Vulnerabilities in Connected Diabetes Devices
Blood glucose meters that send test strip results to phone apps over **Bluetooth Low Energy (BLE)** open a new cybersecurity risk: data that could be ...
iCGM Regulatory Standards
iCGM regulatory standards are the FDA special controls for integrated continuous glucose monitoring systems, created in 2018 when the Dexcom G6 receiv...