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The FDA recently issued guidance on cell phone medical device apps.
Sagentia Inc., a product development company, has developed a medically regulated iPhone app for the Senseonics Glucose Monitoring System. The system, according to Sagentia, has been designed to provide self-management assistance to diabetes patients. Using breakthrough fluorescence sensing technology, the Senseonics system is being designed to be the first fully implantable continuous glucose monitoring system that is highly accurate and stable throughout its long sensor life. The privately held and venture-backed company changed its name nearly a year ago from Sensors for Medicine and Science Inc.
The Senseonics Glucose Monitoring System consists of three major components: an implanted sensor, a wireless transmitter that communicates with the sensor, and a smartphone mobile medical application. After insertion, the system can function non-invasively, automatically and continuously for six months or longer before replacement. With this approach, glucose levels of a patient can be measured every few minutes with alerts sent to the user and his or her physician about impending hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar).
Sagentia was brought into the project as the development partner to provide expertise with Bluetooth low-energy connectivity between the mobile application and the system. The final system was delivered within three months, in time for a clinical trial of the first-generation product. As a result of the collaboration with Sagentia, the Senseonics system is now capable of extremely fast and reliable communication between the smartphone application and the embedded device, yielding a 10-times bandwidth improvement, Sagentia officials report.
“Sagentia has provided tremendous value in the implementation of the novel Bluetooth low-energy technology utilized in our medical mobile app,” said Tim Goodnow, CEO at Senseonics based in Germantown, Md. “Sagentia offered to bring in the subject matter expert to meet the company’s aggressive timeline and partnered effectively with a startup medical device company like ours.”
The Sagentia team initially conducted a system level review of the transmitter hardware, transmitter firmware and application software. Through this analysis the team identified and significantly improved connection drop outs and low data rates. Sagentia then recommended and implemented several user interface improvements.
With its expertise in smart sensing systems, intelligent algorithms, low=power connectivity and big data, Sagentia develops connected health technologies, which can facilitate the management of a patient’s condition at a distance. The potential benefits of connected health systems such as this include increased access to specialist knowledge, improved patient compliance with treatment, greater patient mobility, alerts for acute events and easier collection of clinically relevant data outside of clinical settings.
“At a time of significant budgetary constraint, healthcare providers must find new ways to reduce costs and increase the efficiency and quality of care,” said Dr. David Pettigrew, patient care sector manager at Sagentia. “Ensuring underlying health issues are properly addressed and encouraging lifestyle improvements drives reductions in both the number of people visiting healthcare providers and repeat visits. Technology is proving a key enabler in realizing these aims and connected health breakthroughs like Senseonics’ could have a really significant impact.” Sagentia’s global headquarters are in Cambridge, the United Kingdom, with its U.S. base in Boston, Mass. The company works with clients from opportunity discovery through to concept generation and full product development and transfer to manufacture. The U.S. Food and Drug Administration recently issued guidance on its review of cell phone apps.
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