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Dr. Scott Gottlieb, The new head of the FDA, has made his feelings about mobile health regulation very clear. In 2014, he co-authored  a piece for the Wall Street Journal  about the FDA’s approach to mobile health and in 2015 he wrote  a piece for Forbes . In both, he argued that FDA regulation of mobile health stifles innovation for little benefit. “The ambiguity created by the guidance and the agency’s premarket review processes forces innovators to seek the FDA’s nod for every new launch and every small advance,” Gottlieb and co-author Colleen Klasmeier wrote for the Journal. “This slows progress to a crawl. Worse, the lag may be almost entirely unnecessary, as most of these products are not properly regarded as a medical device in the first place.” Gottlieb argues that regulation for mobile health should be the exception, not the rule.  This would allow innovators and small companies the ability to provide home users with many beneficial monitoring devices. “Most of these pr

Format :  Abstract Send to Artif Intell Med.  2011 Oct;53(2):127-38. doi: 10.1016/j.artmed.2011.05.001. Epub 2011 Jun 22. Non-invasive estimate of  blood glucose  and  blood  pressure from a photoplethysmograph by means of machine learning techniques. Monte-Moreno E 1 . Author information 1 Department Signal Theory and Communications, Universitat Politècnica de Catalunya, Campus Nord, Edifici D5, C/Jordi Girona, Barcelona, Spain. enric.monte@upc.edu Abstract OBJECTIVE: This work presents a system for a simultaneous non-invasive estimate of the  blood glucose  level (BGL) and the systolic (SBP) and diastolic (DBP)  blood  pressure, using a photoplethysmograph (PPG) and machine learning techniques. The method is independent of the person whose values are being measured and does not need calibration over time or subjects. METHODOLOGY: The architecture of the system consists of a photoplethysmograph sensor, an activity detection module, a signal

The estimated annual costs of using test strips... Self-monitoring of blood glucose -related pharmacy costs accounted for 27% of the diabetic  treatment costs for insulin users with an average $772 per patient in prescription testing strips and supplies .  In a review of  373,946 patients prescribed insulin at least twice,  the overall average  of blood glucose  testing resulted in using 764.3 test strips per year (only testing twice a day which is low) , the average cost per testing strip was $0.98. Annual  self-monitoring of blood glucose  costs were 24.5% of total insulin and  self-monitoring of blood glucose -related pharmacy costs. https://www.ncbi.nlm.nih.gov/pubmed/22235952 As you can see, the costs per year are not insignificant...  and stabbing your finger with a needle is annoying too Why test your blood sugar Blood sugar testing — or self-monitoring blood glucose — provides useful information for diabetes management. It can help you: Judge how well you