The U.S. Food and Drug Administration and the European medical regulatory authority have approved St. Jude Medical, Inc.’s Angio-Seal™ Evolution™ Vascular Closure Device. The device is designed to help physicians in sealing the femoral artery punctures that take shape during minimally invasive catheter-based procedures effectively. This enables faster achievement of hemostasis (stoppage of bleeding). Featuring a completely novel delivery system, it reduces the variability occurring during deployment of the system by physicians.

Spiration, Inc. has made an announcement that its IBV® Valve System has been launched by Olympus in the European markets. The minimally invasive device is used for the treatment of various chronic lung problems. The system has already received the CE Mark for use in the treatment of serious diseases of the lung such as emphysema. Initially, the device will be presented to select physicians of Europe. The system may prove to be a boon for  patients who can not or do not undergo surgical operation. Spiration® will continue with manufacturing while Olympus does the distribution.

Dilon Technologies has received CE Marking for its Dilon 6800 gamma camera. The high-resolution gamma camera enables molecular imaging of the breast and other small organs for early cancer detection. It performs breast-specific gamma imaging, a technique that images the metabolic activity of breast lesions through radiotracer uptake.

St. Jude Medical Inc. has received approvals from the US Food and Drug Administration (FDA) and European CE Mark for its Eon Mini, the world’s smallest, longest-lasting, rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery. The Eon Mini neurostimulator is marginally larger than the circumference of a U.S. silver dollar, has a thin 10 mm profile and weighs 29 grams (approximately 1.0 oz.). Its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.

Israel-based Brainsway Ltd. reported positive results from the final stage of testing its noninvasive Transcranial Magnetic Stimulation (TMS) treatment for depression. TMS is a noninvasive technique for applying brief magnetic pulses to the brain. The company said that it had obtained satisfactory results from its first efficacy test on 64 patients. Brainsway now intends to file for an application for CE Mark certification from the EU and subsequently aim for an FDA approval.