Alertgy Inc

Daytona, FL

Biotech Connected Health Diabetes Patient and Provider Tools Patient Power Tools!

Wearable truly noninvasive continuous glucose monitor and alert system that actually measures blood glucose levels real time (Not interstitial glucose like other CGM system currently available that all require sensor probes inserted into the skin or body)

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Check out Alertgy Inc on @MedStartr Today Wearable truly noninvasive continuous glucose monitor and alert system that actually measures blood glucose levels real time (Not interstitial glucose like other CGM system currently available that all require sensor probes inserted into the skin or body). #Biotech #ConnectedHealth #Diabetes #PatientAndProviderTools #PatientPowerTools #Wearables #MedMo #MedStartrVentures

https://www.medstartr.ai/s/T5LG36Ui4Pw

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Clinical Validation

Letter stamped August 28, 2002 from FDA on a similar device creates precedence for an FDA approval due non intrusive nature of the device:   Re: P990026/S008 Gluco Watch G2 Biographer Filed: September 19,2001 Amended: March 1, April 16, and, August 1, 2002 Dear Dr. Kersten: The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) supplement for the GlucoWatch G2 Biographer, which expands the indications for use to include children/adolescents (age 7 to 17) to the currently approved indications for use. This device is now indicated for the following: • The GlucoWatch G2 Biographer is a glucose monitoring device indicated for detecting trends and tracking patterns in glucose levels in adults (age 18 and older) and children/adolescents (age 7 to 17) with diabetes. This device is intended for use by patients at home and in health care facilities. The device is for prescription use only. •The GlucoWatch G2 Biographer is indicated for use as an adjunctive device to supplement, not replace, information obtained from standard home glucose monitoring devices. •The Biographer is indicated for use in the detection and assessment of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of Biographer results should be based on the trends and patterns seen with several sequential readings over time. The PMA supplement is approved. You may begin commercial distribution of the device as modified in accordance with the "Conditions of Approval" (enclosed). This device was not accurate enough for various reasons which we have addressed through the use of advanced dielectric materials and a the use of prorietary machine learning AI advanced IoT cloud based analytics to make the data more precise and accurate.

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MedStartr Engagement Score

202

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