FDA approves Medtronic's 'artificial pancreas' for diabetes
Medtronic Plc won U.S. approval on Wednesday for an "artificial pancreas" that is the first device to automatically deliver the right dose of insulin to patients with type 1 diabetes, freeing them from continually monitoring insulin levels throughout each day.
The U.S. Food and Drug Administration, in its approval of the device, the MiniMed 670G, hailed it as a breakthrough.
The device offers type 1 diabetics "greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin," Dr. Jeffrey Shuren, director of the FDA's medical device division, said in a statement.
Analysts said the FDA approved the device six months sooner than expected. However, it will not be available until the spring of 2017.
The MiniMed 670G is the first device that allows a glucose sensor to communicate with an insulin pump and automatically regulate the insulin flow. The device is approved for those aged 14 and older.
The device measures glucose levels every five minutes and automatically administers insulin as needed. Patients will still need to instruct the device to deliver extra insulin for meals and notify the device when they exercise - which lowers glucose levels.
About 1.25 million American children and adults have type 1 diabetes, a condition in which the pancreas produces little or no insulin - a hormone needed to obtain energy from food.
Patients take insulin injections at various times of the day. But blood sugar can drop to dangerously low levels if too much insulin circulates in the bloodstream, requiring patients to fr Continue reading