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Wednesday, March 17 2010
Medical device developer Teleflex Medical has issued a voluntary recall of the Arrow Select IV Tubing sets, accessories and certain lots of arterial embolectomy catheters after it discovered faults with the product's sterility.
Friday, March 12 2010
The FDA has approved Boston Scientific's Express LD, a premounted, balloon-expandable stent specifically for use in iliac arteries. The company said it plans to launch the product immediately in the U.S.
Sunday, March 07 2010
Stentys has received CE marking for its self-expanding and disconnectable stent to treat acute coronary syndrome.
Friday, March 05 2010
Edwards Lifesciences has received CE mark for its Edwards Sapien XT transcatheter aortic heart valve, as well as its NovaFlex transfemoral and Ascendra 2 transapical delivery systems.
Wednesday, March 03 2010
The FDA has snubbed Forest Laboratories' Supplemental New Drug Application submission that would have indicated nebivolol (Bystolic), currently approved for the treatment of hypertension, as an additional treatment for chronic heart failure (HF).
Friday, February 26 2010
The U.S. Patent and Trademark Office (USPTA) has granted a notice of allowance to cardiac diagnostic technology provider NewCardio for its urgent care solution Cardio3KG.
Monday, February 22 2010
The FDA has granted clearance to Physio-Control, a subsidiary of Medtronic, for unrestricted worldwide distribution of its Lifepak external defibrillator.
Friday, February 19 2010
United Therapeutics has withdrawn its marketing authorization application to the European Medicines Agency for the approval of treprostinil sodium after the Committee for Medicinal Products for Human Use said that the drug was non-compliant with clinical practice.
Wednesday, February 17 2010
As an initiative to curb the rise of diabetes in the U.K., the National Institute for Health and Clinical Excellence has approved the usage of liraglutide (Victoza, Novo Nordisk) for treatment of type 2 diabetes as a triple therapy regimen; however, the agency said data do not yet provide clear evidence to recommend the drug as a stand-alone treatment for type 2 diabetes mellitus.
Wednesday, February 10 2010
The FDA has granted clearance for the marketing of the Eagle Eye Platinum digital intravascular ultrasound (IVUS) catheter in the U.S. by intravascular systems developer, Volcano.
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Friday, March 12 2010
St. Jude Medical has received FDA clearance and European CE Mark approval for the Engage and Engage TR sheath introducers.
Friday, March 12 2010
The FDA has warned healthcare professionals of a class 1 recall regarding the Baylis Medical Torflex Transseptal Guiding Sheath after it found that the sheath tip has the potential to break off and separate during cardiac procedures.
Friday, March 05 2010
St. Jude Medical has received CE mark approval for the Trifecta valve, marking the company’s launch into the market for pericardial aortic stented tissue valves.
Thursday, March 04 2010
SynCardia’s wearable Freedom driver system that allows patients implanted with its CardioWest Total Artificial Heart to be home while awaiting a matching donor heart has received the CE mark of approval for distribution across Europe.
Monday, March 01 2010
LifeScan, a unit under Johnson & Johnson, in conjunction with the FDA, has offered warnings about the use of LifeScan’s OneTouch SureStep test strips, as they have been found to falsely identify blood glucose levels in diabetes patients.
Wednesday, February 24 2010
The FDA has warned physicians to exude caution when administering saquinavir (Invirase, Roche) with a boost of ritonavir (Norvir, Abbott) as a treatment for HIV infection, after a clinical trial found that the combination could potentially cause abnormal heart rhythms.
Sunday, February 21 2010
The U.S. Patent and Trademark office has issued a patent for Positron's Tech-Assist, which reduces radiation exposure to the worker while injecting radiopharmaceuticals into patients when performing PET imaging studies.
Thursday, February 18 2010
The FDA has granted clearance to the Sorin C5 Heart-Lung Machine for use in patients whose heart and lungs are stopped briefly during a cardiothoracic surgical procedure.
Thursday, February 11 2010
The FDA has approved the hypertension treatment Benicar (olmesartan medoxomil, Daiichi Sankyo) for use in children and adolescents six to 16 years of age. Benicar was originally approved in 2002 for the treatment of hypertension in adults.
Monday, February 08 2010
The European Union has granted CE mark of approval for St. Jude Medical’s Fortify ST implantable cardioverter-defibrillator and its Unify cardiac resynchronization therapy-defibrillator for distribution throughout Europe.
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Middle age introduces itself in many ways; one is atrial fibrillation (AF). My onset of AF seems to have coincided with a mountain bike accident in the woods of North Carolina that resulted in some cracked ribs.
The use of health IT to reduce rehospitalizations will be welcome but also disruptive, said Stephen Jencks, an independent consultant in healthcare safety during a Feb. 24 webinar on the potential use of health IT to mitigate rehospitalizations, sponsored by the Agency for Healthcare Research and Quality (AHRQ).