Senseonics Holdings (NYSE-American: SENS) — maker of an implantable continuous glucose monitoring system for people with diabetes — has extended its distribution agreement with Roche Diabetes Care. The agreement extension, announced yesterday, has Roche continuing as Senseonics’ exclusive distributor in Europe, the Middle East and Africa — excluding Scandinavia and Israel. The agreement also adds 17 […]
The UK’s Medicines and Healthcare products Regulatory Agency issued a medical device alert for Roche‘s (OTC:RHHBY) Accu-Check Insight insulin pumps today, warning that the device’s audible and vibration alarms may not function. If a user doesn’t see the notification message on the pump and can’t hear or feel an alarm, it could lead to hyperglycemia, the agency said. […]
Senseonics (NYSE:SENS) said today that it inked a collaboration with TypeZero Technologies and Roche (OTC:RHHBY) Diabetes Care to develop an automated insulin delivery system. The deal is part of an NIH-funded effort to test artificial pancreas systems. The trial is slated to integrate Senseonic’s Eversense glucose monitor, TypeZero’s inControl AP algorithms and Roche’s Accu-Chek Insight insulin pump. The software automatically […]
Roche (PINK:RHHBY) this week said it launched the Accu-Chek Guide System blood glucose meter. The company said that the Accu-Chek Guide meter is designed to help simplify diabetes management, featuring a spill-resistant test-strip vial, a large blood application area and strip ports for checks at different times during the day. The Accu-Chek Guide System is designed […]
Roche (PINK:RHHBY) denied rumors that it was considering selling its diabetes unit today, saying that it is “committed” to the business. The company also predicted that competition and spending on new drugs would stall its margin growth in 2017, as patents expire for its blockbuster medications. The Swiss drugmaker’s 3 top-selling cancer drugs, Rituxan, Herceptin and […]
Danaher (NYSE:DHR) said it lured Brian Ellis from Medtronic (NYSE:MDT) to be its new general counsel, replacing Jonathan Graham, who jumpoed ship for Amgen (NSDQ:AMGN) last May. Ellis was general counsel for Medtronic’s restorative therapies group, after stints as GC and chief compliance officer for monitoring solutions at GE Healthcare (NYSE:GE) “Brian brings a wealth of experience leading and […]
Biotech titan Roche secured a landmark FDA win with clearance for its Accu-Chek Aviva Expert blood glucose meter, the 1st of its kind with a built-in insulin calculator to help guide patient therapy.
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.