European regulators temporarily suspend sales of GI Dynamics' EndoBarrier weight loss device, sending share prices plummeting.
ReFlow Medical wins CE Mark approval in the European Union for a pair of crossing catheters, the Wingman35 and Spex devices.
ReFlow Medical said physicians in Germany are already using its Wingman35 and Spex crossing catheters, after the San Clemente, Calif.-based company won CE Mark approval for both devices for treating lesions in the peripheral vasculature.
Mazor Robotics says it won approval from the China Food & Drug Administration for its Renaissance robot-assisted surgery device for spine procedures.
Becton, Dickinson's COO says the company plans to make more than half its products in Asia over the next decade, aiming to take advantage of rising government healthcare spending there.
Medtronic says Health Canada approved the use of its enhanced Enlite glucose sensor with the MiniMed Veo insulin pump and continuous glucose monitoring system.
Direct Flow Medical wins CE Mark approval in the European Union for the smallest size of its replacement heart valve and another EU nod for implanting the device without contrast media.
Direct Flow Medical said today that it won CE Mark approval in the European Union for an additional size of its replacement heart valve, plus an EU OK for the use of the devices without contrast media.
Cook Medical says it's begun enrollment in a clinical trial in China for its Zilver PTX peripheral stent.
Cook Medical said it enrolled the 1st patient in a 1st-of-its-kind clinical trial in China for its Zilver PTX drug-eluting peripheral stent as it looks to win approval for the device in the People's Republic.