Texas based AirStrip Technologies, Inc. has received CE Mark certification to market its innovative mobile patient monitoring applications in the European Community as well as other international territories outside Europe.
Regulatory
FDA Likes “Chocolate”… PTA Balloon Catheter
TriReme Medical, Inc.has received 510(K) FDA approval to market its “Chocolate” PTA balloon catheter for the treatment of occluded peripheral arteries in the United States.
St. Jude Completes Enrollment In “RESPECT” PFO Occlusion Trial.
St. Jude Medical, Inc. has announced that it has met a stopping rule in its RESPECT clinical trial and is closing patient enrollment. The company expects to present its findings during 2012.
St Jude Launches Website Dedicated To Riata Silicone Lead Management
St. Jude Medical, Inc. has launched a Riata Lead Communication website to provide physicians with a compilation of important communications and updated information regarding the recent Riata® and Riata® ST Silicone Defibrillation Leads Class I recall.
PIP: One Bad Apple?
While we can all point fingers at the PIP breast implant situation as being a one-off, all parties must look in the mirror to ensure this is used as a lesson in how things can go wrong.
PIP Breast Implants: How Did This Happen?
medlatest speculates about whether regulatory controls are tight enough when a company can substitute “mattress grade” silicone for that which was approved in the regulatory process.
Bioptigen’s Ophthalmic Imaging System Gains CE Mark
US ophthalmologic imaging technology company Bioptigen Inc., has received regulatory approval to market its hand-held Envisu C2000-series systems for clinical use within the European Union
Covidien Announces CE Mark for Nellcor™ Respiration Rate Software
Covidien extends the functionality of its Nellcor respiratory monitoring platform with CE Mark approval for its Nellcor™ Respiration Rate Version 1.0 Software and the Adult Respiration Rate Sensor.
CE Mark For SonoSite’s New Edge Ultrasound System
SonoSite, Inc.has received CE Mark approval to market its next generation point-of-care product: EDGE™ ultrasound system in the European Union.
FDA Wants Shrinkage Warning on Boston Scientific’s Newly Approved Promus Element™ Stent
Boston Scientific’s Promus Element Drug Eluting Stent was approved by FDA in late November and now the agency has demanded that the company includes a warning on its packaging about the risk of stent shrinkage.
FDA Approves AtriCure’s Synergy Ablation System For Atrial Fibrillation Treatment
First and Only System in the United States Approved to Treat Patients with Persistent and Long-Standing Persistent Atrial Fibrillation
CE Mark For Robotic Catheter Guidance Control and Imaging™System .
California-based Magnetecs Corporation has reported that the company’s Robotic Catheter Guidance Control and Imaging™ (CGCI) System has received CE Marking certification.
St Jude Riata Voluntary Recall Judged By FDA as Class 1
12 months after European regulators issued alerts, St. Jude Medical, Inc. has now announced that following its voluntary medical device advisory letter to physicians from Nov. 28, 2011 the U.S. Food and Drug Administration (FDA) has now classified this action as a Class I Recall.
Infrascan Gains FDA Approval For Its Hand-Held Intracranial Haematoma Detection Device.
FDA permits marketing of Infrascanner 1000, the first hand-held device to aid in the detection of intracranial haematoma.
Counterfeit Medical Devices: More Probable Than Possible
RAM Medical has admitted to importing and selling counterfeit and contaminated surgical hernia mesh. Is this a one-off, or could such practices be widespread and global?
da Vinci Single Site Lap Chole System Gains FDA Approval
Intuitive Surgical, Inc. the global leader in minimally invasive robotic-assisted surgery, has announced that it has received FDA clearance to market its Single-Site Instrumentation for laparoscopic cholecystectomy procedures.