Medtronic, Inc. has announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its Aquamantys®3 System as well as the new 8.2L Bipolar Sealer with Cutting and 6.0 Bipolar Sealer hand pieces.
Danish company Unisense Fertilitech has announced the gaining of FDA approval for its EmbryoScope® for clinical use in the United States.
GE Healthcare (NYSE:GE), has announced FDA 510(k) clearance of an innovative technology to aid the physician in breast cancer diagnosis.
Cook Medical has announced that its Evolution® Duodenal Controlled-Release Stent was recently granted 510(k) clearance by the Food & Drug Administration (FDA)
Titan Spine, has announced that it has received FDA clearance to commercially release its Endoskeleton® TAS system, consisting of an ALIF device with integrated fixation screws.
Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its CorMatrix® ECM® for Carotid Repair, which utilizes the company’s proprietary ECM Technology.
Sorin announced at the Venice Arrhythmias 2011 Congress, CE Mark approval and the European commercial launch of its innovative SonR CRT optimization system
ISTO Technologies, Inc., has announced that it has received the CE Mark approval for its InQu® bone graft substitute and extender, enabling the company to initiate a commercial launch of the product in Europe.
Two years after receiving CE mark approval, Cook Medical’s Zilver® PTX® Drug-Eluting Stent Technology has received unanimous recommendation for approval from FDA Advisory Committee
The FDA has approved Boehringer Ingelheim’s Combivent Respimat, a propellant-free inhaler for patients with chronic obstructive pulmonary disease (COPD).
Bioness Wireless Hand rehabilitation System gains FDA and CE mark approval. The device’s Wireless capability allows for seamless integration of device into daily life, increasing therapy time and patient compliance.