Tandem Diabetes Care and PositiveID (OTC:PSID) landed FDA clearance for their t:slim portable insulin pump and iglucose diabetes management systems, respectively.
San Diego, Calif.-based Tandem Diabetes Care designed the t:slim to mimic the look of a smartphone or small tablet with a color touchscreen. Patients can connect the pump via USB port to their computer and upload up to 90 days of insulin pump or glucose meter data to the web.
“In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use. Give us access to the most advanced features without extra effort,’" Kim Blickenstaff, Tandem’s president & CEO, said in prepared remarks.
The t:slim was one of the first insulin pumps to be cleared under the federal watchdog agency’s Infusion Pump Improvement Initiative.
It is currently the smallest insulin pump system on the market.
"Medical devices are often designed for the hospital setting, not for everyday life. Things like size, look, and feel are often overlooked," Timothy Bailey, director of the Advanced Metabolic Care & Research Institute said in prepared remarks. "Patients need an insulin pump designed to easily integrate into their daily lives. The device needs to be unobtrusive and look more like the consumer electronics they already use every day."
PositiveID’s iglucose system landed FDA approval to send glucose readings from data-capable glucometers to the iglucose diabetes management portal where information can be shared with doctors, caregivers and family members via text, e-mail or fax.
"Most people do not keep consistent and accurate logbooks," said the company in a press release. "iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition."
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