iRhythm device enables arrhythmia diagnosis for all patients as early as possible in their course.
Regulatory
BIONESS INC RECEIVES FDA CLEARANCE AND CE MARK FOR ITS NESS H200 WIRELESS SYSTEM FOR HAND PARALYSIS AS A RESULT OF STROKE AND OTHER CENTRAL NERVOUS SYSTEM DISORDERS
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.
LeGoo gel approved by FDA for blood vessel surgery
The FDA has approved LeGoo from Pluromed, a gel that allows surgeons to temporarily stop blood flow during surgery involving blood vessels. the product already carried CE marking.
Electronic labelling of medical devices a boon for people’s safety, accuracy of instructions and environment
EU Regulatory Committee on Medical Devices approves regulation on e-instructions for use of medical devices
MAQUET CARDIOVASCULAR RECEIVES FDA 510(K ) CLEARANCE AND CE MARK FOR ITS NEW SENSATION PLUS™ INTRA-AORTIC BALLOON CATHETER
MAQUET Cardiovascular, a leading provider of cardiovascular technologies, announced today that it has received both 510(k) clearance from the U.S. Food & Drug Administration (FDA) and CE mark approval for its new SENSATION PLUS™ 50cc 8 Fr. intra-aortic balloon catheter.
Clinicians of the world, should you only use FDA approved products?
Products available for everyday use in Eu are often not yet in use in humans even under trial conditions in USA.
First Patients Enrolled in the U.S. OPEN Clinical Trial of the FlexStent(R) Femoropopliteal SE Stent System
Flexible Stenting Solutions Inc. has announced the successful treatment of the first two patients enrolled in the OPEN (Evaluation of Safety and Efficacy of the FlexStent(R) FemorOPopliteal Self-Expanding StENt System) clinical trial.
Reprocessing of “single-use” devices. Pragmatism rules
Reprocessing of “single-use” devices will be allowed subject to restriction of movement of reprocessed goods.
Baxter Announces FDA Approval of ARTISS Fibrin Sealant For Use in Face-Lift (Facial Rhytidectomy) Procedures
Baxter International Inc. has announced that FDA has expanded the indication of ARTISS [Fibrin Sealant (Human)] to include adhering tissue flaps during facial rhytidectomy surgery (face-lift)
Sapheon, Inc. Receives CE Mark Approval for New Varicose Vein Treatment
Sapheon Inc. has received CE Mark approval for its new approach to the treatment of varicose veins caused by venous reflux disease.
MAQUET CARDIOVASCULAR RECEIVES FDA 510(K ) CLEARANCE AND CE MARK FOR ITS NEW SENSATION PLUS™INTRA – AORTIC BALLOON CATHETER
MAQUET Cardiovascular has announced that it has received both 510(k) clearance from the U.S. Food & Drug Administration (FDA) and CE mark approval for its new SENSATION PLUS™ 50cc 8 Fr. intra-aortic balloon catheter.
Spine Surgery Patient Brings Suit Against Medtronic, Inc. (MDT) for “Devastating Side Effects” From off label application of its Infuse Bone Graft Medical Device
Embattled medical device giant Medtronic Inc is feeling the heat again, as reported on www.devicespace.com. This time it is alleged … continue reading “Spine Surgery Patient Brings Suit Against Medtronic, Inc. (MDT) for “Devastating Side Effects” From off label application of its Infuse Bone Graft Medical Device”
Abiomed Announces First Patient Enrolled In MINI-AMI FDA Study
Abiomed, Inc. has announced the first patient enrolled in MINI-AMI, an FDA prospective, randomized, controlled multi-center study to assess the role of 24-hours of direct unloading of the left ventricle with Impella(R) 2.5 support to reduce infarct size in patients with ST-elevation myocardial infarction without cardiogenic shock.
Eucomed Guidelines On Interactions with Healthcare Professionals
Excerpt from Eucomed’s Q&A guidance document issued in August 2011.
CANNULATED DEVICE REPROCESSING; FDA workshop feedback
Reprocessing cannulated devices has long been a problem. This article discusses a recent FDA workshop on the subject and has relevance for all users and processors of such devices. It also notes that Singe Use Surgical, a UK company provides disposable alternatives to many such at-risk devices
Medtronic’s pain pump recall won’t hurt the bottom line, analysts say
Analysts don’t expect Medtronic’s second Class I recall for its SynchroMed II implantable painkiller pump to put much of a dent in the overall business.