(Ann R. Thryft. 11-16-22. Mddionline.com) A team made up of Sensoria Health, Foot Defender, and former Nike shoe designers came together to create a cloud-based patient monitoring boot for Diabetes patients. On the extreme, but very realistic side, this technology could help save patients from requiring an amputation if used correctly after ulcer surgery. The...Read More

FDA issued a draft guidance for prescription POC (Point-of-care) entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.” This draft guidance document provides recommendations to industry about the types of information to include in their premarket submissions for blood glucose monitoring systems used for diabetes management in the health care prescription POC settings. This guidance...Read More

FDA issued a draft guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use“‘. This draft guidance document provides recommendations to industry about the studies and criteria to include in their premarket submissions for self-monitoring blood glucose test systems used for diabetes management in the home setting. This guidance (similar to the Prescription POC guidance)...Read More