Dexcom wins European approval for next-gen continuous glucose monitor
San Diego, Calif.-based Dexcom Inc. (NSDQ:DXCM) won CE Mark approval for its latest generation continuous glucose monitor, the Dexcom G4.
The device touts improved performance and reliability, according to CEO Terrance Gregg, and the company is working to establish a commercial launch plan for the coming months.
Dexcom specializes in continuous blood glucose measurement tools, with wearable devices for patients as well as tools designed for hospital use, according to a press release.
The device maker recently announced a partnership with the Juvenile Diabetes Research Foundation, aimed at developing a wireless transmission system to send data from a continuous glucose monitor to an "artificial pancreas" which would respond to highs and lows in blood sugar by automatically adjusting the flow of an insulin pump.
DXCM shares were up 2.6% to $12.41 as of about 5:00 p.m. today.
Abiomed lands Canadian approval for Impella cVAD heart pump
Abiomed (NSDQ:ABMD) continued its global march with Canadian approval for its Impella catheter-based heart pump used to provide support for patients with heart conditions.
Regulators approved the device for up to 5 days of use in cardiology and cardiac surgery as a circulatory support system for patients with reduced pumping ability.
The Impella cVAD device noted 1st-in-man use in April and won CE Mark approval in the European Union just weeks later. The device has yet to win clearance in the U.S.
ABMD shares were up 2.2% to $21.42 as of about 5:00 p.m. today.
FDA approves world’s thinnest full-length cochlear electrode
Cochlear Americas won FDA approval for newest electrode for use in implantable hearing solutions, the Slim Straight. The device is designed to preserve delicate cochlear structures as its inserted into the inner ear.