FDA grant 510(k) approval for Dario Blood Glucose Monitoring System in type 2 diabetes- LabStyle Innovations
LabStyle Innovations has announced that the FDA has granted 510(k) clearance for the Dario Blood Glucose Monitoring System, including its components, the Dario Blood Glucose Meter, Dario Blood Glucose Test Strips, Dario Glucose Control Solutions and the Dario app on the Apple iOS 6.1 platform and higher.
The Dario Blood Glucose Monitoring System is indicated for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system helps people with diabetes monitor their blood sugar levels and proactively manages their diabetes using their smartphone. Dario connects via a headphone jack to turn a mobile device into a glucose monitor, and incorporates a lancing device and test strips together with the meter in an all-in-one device to take blood glucose measurements on the spot. It also provides real-time and historical blood glucose data to allow health care providers to spot patterns, recommend treatments and support behavior changes.
Related news and insights
Innovent Biologics, Inc. and Eli Lilly and Company announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for Tyvyt (sintilimab injection) in combination with fluorouracil and platinum-based chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma.
Seagen Inc. announced full results from the pivotal phase II MOUNTAINEER trial , which showed Tukysa (tucatinib) in combination with trastuzumab was well-tolerated with durable responses in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC).
Basilea Pharmaceutica Ltd., announced that its license partner, Pfizer Inc., has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the intravenous formulation of Cresemba (isavuconazole) for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. This is the second approved formulation for Cresemba in China, in addition to the oral formulation for invasive aspergillosis and invasive mucormycosis.