Archive for the ‘FDA’ Category
Intervalve’s V8 Aortic Valuloplasty Balloon Catheter Gets FDA 510(k) Clearance
Intervalve has recently announced that their new V8 Aortic Valvuloplast Balloon Catheter has received 510(k) clearance and will be used for both balloon valvuloplast procedures (BAV) and transcatheter aortic valve replacement (TAVR) procedures. Read More »
Olympus goes 3D
Laparoscopy has seen many advances and changes during the last few years, although this has always been limited by the constraints of two dimensional (2D) imaging. Conventional 2D laparoscopy lacks both depth perception and spatial orientation, possibly affecting surgical performance and operative time. Three dimensional laparoscopy on the other hand offers the surgeon a more natural visualization of the operating site with depth perception. This allows procedures to be performed more efficiently and accurately than is possible with 2D laparoscopy; all of which adds up to increased safety for patients and better outcomes. Read More »
St Jude Medical’s Deep Brain Stimulation Trifecta: New Treatment Options for Dystonia in EU
St Jude Medical recently announced on April 10th that they received the European CE mark of approval on three deep brain stimulation (DBS) systems for the treatment of Dystonia symptoms. The Libra™, LibraXP™, and Brio™ systems are the first to gain approval from a regulatory agency for use in the treatment of symptoms from primary and secondary Dystonia. Currently there are no clinical trials ongoing for FDA approval that might indicate when the US market can expect to see St Jude’s DBS. Read More »
Patient Monitoring & Infusion Pumps: Increase Efficiency and Improve Patient Safety & Outcomes
Last week Lee Barnhart and James Laskaris gave an informative talk during their webinar titled: “Patient Monitoring & Infusion Pumps: Increase Efficiency and Improve Patient Safety & Outcomes.” They focused on the market, safety concerns and considerations as well as how to best optimize purchasing for infusion pumps and patient monitoring. Read More »
iCAD Continues to Grow Their Xoft Axxent eBx System
Since iCAD announced their acquisition of the electronic brachytherapy company Xoft in December 2010, they have been plagued by a series of setbacks. This was largely due to a combination of the Flexishield recall in 2011 and an initial lack of reimbursement. Now, in 2013, despite the lingering possibility of legal liability, iCAD has placed the Flexishield recall behind them. Read More »
Siemens Releases New Angiography Solutions – Artis Q and Artis Q.zen
With their Artis zee line of imaging systems, Siemens has been heavily involved in the Cardiac and Vascular Angiography Market. Their most recent additions, Artis Q and Artis Q.zen systems, were developed as a result of the increasing focus on radiation dose exposure to patients and clinician alike. Read More »
EndoBarrier Therapy: Helping Patients Achieve Control Over Obesity and Diabetes
According to the National Diabetes Information Clearinghouse, 8.3% of the US population or 25.8 million people are affected by diabetes, including an estimated 7 million with undiagnosed cases. The Centers for Disease Control and Prevention (CDC) has also noted that 35.7% of all adults and 16.9% of children (ages 2-9) are considered obese. Overall obesity rates are projected to exceed 40% by the year 2030 and over 60% in 13 other states. Read More »
Insight on The Image Gently ® Campaign and X-ray Exams
Radiation dose, you can’t see it, smell it or even touch it, but it’s there every time you receive an X-ray, a CT scan or undergo any ionizing imaging exam. The dosage of radiation received during these exams is a concern across all age groups, but children in particular have been shown to be more susceptible to developing cancer as a byproduct of X-rays compared to their adult counterparts. Read More »
Quidel’s Amplivue for Faster C. diff Detection
Despite a decline in healthcare-associated infections (HAIs) as reported by the Center for Disease Control, infections from the bacteria C. [...] Read More »
Cook Medical Wins FDA Approval for 1st Drug-Eluting Stent for PAD
While drug-eluting stents have been widely used in coronary arteries, Cook Medical is the first to win FDA approval for [...] Read More »