Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
Having an accurate record of food and alcohol intake is important for managing a number of diseases including diabetes, various cardiovascular conditions, and alcoholism. Currently, not much practical technology is available to do this aside from smartphone apps, and apps tend to be tedious and require constant vigilance of making sure to input all the data.
AstraZeneca today announced that the European Medicines Agency has accepted the Marketing Authorisation Variation forForxiga (dapagliflozin), a selective SGLT-2 inhibitor, for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D).
A major medical association today suggested that doctors who treat people with Type 2 diabetes can set less aggressive blood sugar targets. But medical groups that specialize in diabetes sharply disagree.
Senseonics Holdings Inc has announced that people with diabetes using the Eversense® brand Continuous Glucose Monitoring Systems, in EMEA markets now have the option to invite others to remotely view their real-time glucose readings and alerts from anywhere.
The FDA has ordered the recall of a mHealth app that helps people with diabetes determine how much insulin they should inject. The issue points to the continuing challenge of verifying the accuracy of digital health devices and drug dosage apps.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has put forward seven new medicines for approval in the region, including new treatment options for haemophilia A, diabetes, and a very rare genetic disorder.
Chinese bidders are circling a diabetes care business owned by the world's largest health-care company Johnson & Johnson in a deal that could fetch up to $4 billion, five people with direct knowledge told Reuters.
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