April 14, 2014 — San Diego — Entra Health today announced the launch of the MyHealthPoint Entra Health today announced FDA 510K Class II approval for the MyHealthPoint® real-time online data collection network (K932130). The MyHealthPoint platform allows patients to upload and report a broad range of data including blood glucose, blood pressure, ECG, weight and activity monitoring data, along with nutrition and other biometric input from devices produced by various manufacturers around the world.
“The review process for 510(k) notifications is one of the most rigorous regulatory hurdles for evaluation of the performance, accuracy, data collection and analysis,” said Richard C. Strobridge, CEO of Entra Health. “Today’s announcement demonstrates that the MyHealthPoint platform has met that standard and is an important step in our mission to manage and deliver actionable patient data to clinicians, care givers and clinical trial sponsors around the world.”
The MyHealthPoint platform includes thirteen FDA Product Codes and integrates with MyGlucoHealth, the first FDA cleared wireless blood glucose meter. In diabetes research, MyGlucoHealth has become the de facto standard for glucose data collection in clinical trials and has regulatory approvals in 50 countries.
MyHealthPoint platform is categorized as a Class II device for patient monitoring under the product code: automated calculation of a summary index based on several individual measured vital sign inputs. Within MyHealthPoint personal information is HIPAA compliant, stored in a secure, encrypted database with privacy controls set by the individual, clinician or caregiver, including what information goes in and who gets to see it. This data helps clarify and define clinical trial and treatment strategies to improve overall patient care.
About Entra Health
Entra Health is an international digital health and IT solutions provider that is focused on cloud-based remote patient monitoring, telehealth, data exchange and analytics. Entra Health’s secure Platform-as-a-Service (“PaaS”) remote patient monitoring solutions and devices have regulatory approval in 50 countries. The company is an international leader in wireless biometric data collection for clinical trials. For more information visit: www.entrahealth.wpengine.com or call 877-458-2646.
MyGlucoHealth™, MyHealthPoint™ and Entra360™ are trademarks of Entra Health Systems.
Bruce Ahern, Chief Marketing Officer
Entra Health Systems