ClearCount Medical Solutions has received approval to affix the CE mark to its SmartSponge and SmartWand-DTX products.
Regulatory
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.
Eucomed Blogs on the Benefits of the European Medical Technology Regulatory Domain
“Collaboration across member states in many sectors and activities makes perfect sense at all levels so let’s celebrate the positives whilst not trying to force greater integration where it does not work for all,” says Eucomed Chief Executive.
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
Medical Device Alert on Aquarius Haemofiltration Device
UK MHRA has issued a Medical Device Alert (MDA) on the Aquarius Haemofiltration Device manufactured by Nikkiso Europe GmBH and distributed by Baxter Healthcare.
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.
FDA Advisory Panel Makes Recommendation on Investigational Medtronic Phased RF Ablation System for Treatment of Persistent or Long-Standing Persistent Atrial Fibrillation
Medtronic has announced that the FDA Circulatory Systems Devices advisory panel has voted against the company’s Phased RF Ablation System,
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
Atricure’s Press Release confirms FDA Panel decision re: Synergy Ablation Indication
Circulatory System Devices Panel Votes in Favor of FDA Approval for AtriCure’s Surgical Ablation System to Treat Atrial Fibrillation
AtriCure Wins Panel Backing for Atrial Fibrillation Indication
An advisory panel to the FDA has voted 5-3, with one abstention, to recommend Atricure’s ablation device for patients with atrial fibrillation.
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.