1. Angiodroid wins CE Mark for Angiopulse IABP
Angiodroid announced in a July 11 press releasethat it has received CE Mark approval for its AngioPulse intra-aortic balloon pump device. The AngioPulse uses a new system for intra-aortic balloon pumps based on pressure regulation. It is designed for weaning solutions and is suitable for all types of patients needing intra-aortic balloon pump therapy.
2. Visura Technologies wins FDA nod for disposable TEE camera
Visura Technologies has received FDA 510(k) clearance for its TEE Camera Assist Device (TEECAD), according to a July 10 press release. The TEECAD has a single-use disposable camera that can be easily attached to a transesophageal echocardiogram (TEE) ultrasound probe to give physicians a view of the upper airway and esophagus during probe placement for a safe intubation process. The camera view can be viewed from a separate viewing system display to see real-time images from the camera.
3. FDA clears Oculocare’s Alleye wet AMD monitor
Oculocare announced in a July 9 press release that it has received FDA 510(k) clearance for its Alleye mobile medical software application. Alleye is designed to be used for detecting and monitoring age-related macular degeneration. It detects and characterizes central and paracentral metamorphopsia in patients who have macular conditions like AMD and diabetic retinopathy. Alleye gives patients the chance to regularly perform simple self-tests at home to help monitor eyesight or assess disease progression.