Medtronic PLC (NYSE:MDT) Seeking FDA Nod For Artificial Pancreas

Medtronic PLC (NYSE:MDT) Seeking FDA Nod For Artificial Pancreas

Medtronic PLC (NYSE:MDT) has sought the approval of the FDA to market its device that acts as an artificial pancreas. The device is targeted at diabetes sufferers as it helps with controlling blood glucose levels. Medtronic already markets the device in markets such as the U.K., but its launch in the U.S. could come next year if the regulator clears it for approval.

Medtronic did not provide an estimate of the revenue it is expecting from the sale of the artificial pancreas in the U.S. However, the company’s diabetes business generated revenue of $496 million in 1Q2016. According to the head of the diabetes division at Medtronic, they have a plan to launch more diabetes products in the coming five years than they have launched in the past 15 years.

Medtronic’s diabetes products include insulin pumps, whose sales last year rose 30% outside the U.S.

How the artificial pancreas works

Medtronic’s artificial pancreas device automatically monitors the glucose levels in the blood using sensors and automates the delivery of insulin to prevent hypoglycemic incidents. The device comprises a glucose sensor and the MiniMed 670G insulin pump that are connected to an insulin delivery device. Medtronic has included a display similar to that of a smartphone from where a wearer of the system can view information.

The whole idea of the artificial pancreas is to have a device capable of automatically adjusting blood glucose levels to improve the quality of life for diabetes sufferers. If the FDA approves the device, it will become the first artificial pancreas to be marketed in the U.S.

According to Medtronic, the sensors used in its artificial pancreas can be worn for seven days before they require recharging. The insulin pump on its part needs to be replenished every three days.

$1.1 billion acquisition of HeartWare

Medtronic’s application for approval of the artificial pancreas comes on the heels of a deal to acquire HeartWare International Inc. (NASDAQ:HTWR) for $1.1 billion. HeartWare is the name behind the HVAD heart pump that is used in the treatment of heart failure.