Abbott announced it has received CE Mark approval for its new, highly sensitive diagnostic test for detection of hepatitis B surface antigen.
Approval/Clearance
Cordis Empira PTCA Catheters get 510(k) approval for Coronary Artery Disease
Cordis Corporation has announced EMPIRA™ and EMPIRA™ NC RX PTCA Dilatation Catheters have received 510(k) regulatory clearance for the treatment of coronary artery disease.
Edwards Receives FDA Approval to Expand U.S. Clinical Trial of Next-Generation Transcatheter Valve
Already approved in Europe since March 2010, Edwards’ Sapien XT valve now gains further investigational device study arm in USA.
CE Mark for New Lead Enhances abiliti® Food Sensing/Gastric Stimulation System
IntraPace, Inc. has announced that it has received CE Mark for the LGL102, a new gastric stimulation/food sensing lead designed to work with the innovative abiliti(R) system, an implantable weight loss management system.
CE Mark for a New Embolic Protection System During TAVI
Claret Medical Announces CE Mark of a New Embolic Protection System to Address Stroke During Transcatheter Aortic Valve Intervention
ClearCount Announces First and Only CE Marked RFID-based Surgical Sponge System
ClearCount Medical Solutions has received approval to affix the CE mark to its SmartSponge and SmartWand-DTX products.
Edwards Lifesciences Receives FDA Approval for First Catheter-Based Aortic Heart Valve in the U.S.
Edwards Lifesciences gains first U.S. commercial approval for a transcatheter device enabling aortic valve replacement without the need for open-heart surgery.
Bang for Buck is Getting Tougher to Prove and Isn’t Always Enough
Medical Device Daily has published an interesting article on Cook Medical’s successful passage through FDA’s advisory panel meeting and what it tells us about bringing new technology to market.
TriVascular Ovation Endograft, Previously CE Marked, Now FDA Approved
TriVascular Inc. has announced that its Ovation Endograft has now been approved for use by FDA.
Abbott Receives U.S. FDA Approval for Next-Generation XIENCE PRIME™ Drug Eluting Stent
Following CE Mark approval in 2009, Abbott now gains FDA approval for Xience Prime Drug Eluting Stent
Medtronic Receives First FDA Approval of Cobalt Chromium Balloon-Expandable Stent to Treat Narrowed Iliac Arteries
Assurant® Cobalt Iliac Stent Features Novel Alloy and Modular Design; Company’s Peripheral Portfolio Augmented with Balloon-Expandable Option
ArthroCare(R) Receives FDA Clearance for SpeedLock(R) Knotless Fixation Device
ArthroCare Corp. has announced that it has received US FDA clearance for its SpeedLock(R) Knotless Fixation Device
Apnex Medical, Inc. Receives CE Mark Approval for HGNS ® System to Treat Obstructive Sleep Apnea
Apnex Medical, Inc., has received CE Mark approval for its Hypoglossal Nerve Stimulation (HGNS®) System for use by people who suffer from obstructive sleep apnea.
St. Jude Medical Announces FDA Clearance of First and Only Combined FFR and OCT System
Following its launch in Europe earlier this year, St Jude’s Ilumien OCT/FFR Coronary Artery Disease diagnostic tool
Crospon receives FDA clearance for External Channel endoscopic accessory
Crospon: Market launch for EF-800 external channel endoscopic accessory device anticipated by year end
Atricure’s PMA approval for Atrial Fibrillation indication under scrutiny this week
Cardiac device maker Atricure (NASDAQ:ATRC) share price dropped on Monday after an FDA report expressed “concerns” about a clinical trial intended to support expansion of indications for one of the company’s ablation devices.