The Medical Device Business Journal — Medical Device News & Articles | MassDevice
MASSDEVICE ON CALL — Roche (PINK:RHHBY) and Glooko partnered to provide wireless data transmission between iPhones and glucose meters for patients with diabetes.
Mobile diabetes management startup Glooko lent its MeterSync infrared data transfer technology to enable diabetic patients to access readings from Roche’s Accu-Chek blood glucose meters.
Roche (PINK:RHHBY) won clearance from the U.S. Food & Drug Administration for its Accu-Chek Nano SmartView blood glucose monitoring system.
The Switzerland-based biotech builder’s no code meter is smaller than a credit card that allows patients to customize test reminders, pre and post meal markers and calculate their average glucose levels.
Roche Diabetes Care glucose test strips may falsely report elevated blood glucose levels, prompting the FDA to slap the devices with Class 1 recall status, the most serious type of recall that involves situations with a reasonable probability that continued use will cause serious injury or death.
The Roche strips were distributed in France in October 2010 and were never distributed in the U.S.
Roche Diabetes Care’s Insulin Delivery Systems unit issued a recall for one of its infusion sets while it tries to work out the kinks — literally.
There’s a possibility that its Accu-Chek FlexLink Plus will under-deliver insulin because the tube that delivers the medication, the cannula, can become kinked, according to the company.
