Products

EnteroMedics Inc., has developed neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders.  In a move that is … continue reading “Vagus Nerve Blocking Obesity Treatment on the Road to FDA Approval”

Abbott has announced that it has received U.S. FDA clearance for its FreeStyle Precision Pro Blood Glucose and β-Ketone Monitoring System™, which it describes as an advanced blood glucose monitoring system designed to address the key needs of hospital customers.

US device regulatory agency the FDA has issued a Class I recall, it’s highest category recall, for the LeMaitre Vascular Albograft Vascular graft, for the reason that it may leak from its surface following implantation. The same product was the subject of recall activity in Europe in March 2012, due to reports of profuse bleeding through the wall of the graft.

Aurora Spine has now received the CE Mark Approval for its ZIP™ MIS Interspinous Fusion System, meaning it can now be sold in the European Union and other countries that recognize or require this approval.

Dallen Medical has announced that it has submitted an FDA 510(k) application as it seeks clearance for its proprietary Tensyn™ Band for syndesmosis repair.

American Medical Systems® (AMS), Inc., has announced the U.S. launch of its MiniArc™ Pro single-incision sling system for the treatment of female stress urinary incontinence. The MiniArc Pro is designed with a new visual feedback system that gives the physicians the ability to objectively measure sling tension in a repeatable way to help find the most accurate placement for their patient.

Cook Medical has launched the Biodesign® ENT Repair Graft, which acts as an adjunct to aid in the natural healing process following nasal and sinus mucosal surgery. The product is designed for rhinologists who treat patients that suffer from difficult-to-heal conditions in the nasal passages.

Swedish company Elekta AB has received CE marking for its Clarity® 4D Monitoring system permitting European clinics to implement this new way of reducing the uncertainty caused by prostate motion during radiation treatment. The device enables physicians to monitor the motion of the prostate with sub millimeter accuracy during the delivery of therapeutic radiation beams.

ValveXchange®, Inc., says it is moving a step closer to market, having submitted its application for CE mark approval. The … continue reading “Novel Serviceable Heart Valve May Offer Potential of Transcatheter Re-do’s”

Ceterix™ Orthopaedics, Inc. has announced the commercial availability of its NovoStitch™ suture passer in the United States. The device enables surgeons to place stitches in tight joint compartments, including those in knees, hips and shoulders, during minimally invasive arthroscopic surgical procedures.

GE Healthcare’s new digital mammography imaging technology is claimed to achieve results previously only attainable with higher X-ray doses. In addition it promises superior sensitivity and lesion margin specificity.

Bacterin International Holdings, Inc. has obtained US FDA 510(k) approval to market OsteoSelect® DBM Putty for use in spinal fusion procedures. OsteoSelect® is a moldable bone graft substitute designed to withstand irrigation while exhibiting osteoinductive properties for improved bone regeneration.

Australia’s regulatory authority, the Therapeutic Goods Administration (TGA) has issued a hazard alert pertaining to one of Medtronic’s pacing devices, the Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P). The action coincides with the company’s recall of certain Consulta and Syncra CRT-P devices.

“The Committee considered that making the Ambu aScope2 available for use in typical clinical settings is likely to improve outcomes … continue reading “UK’s NICE Issues Positive Guidance On Device For Visual ET Tube Insertion”

Colonoscopy compliance rates in Japan, a company with a runaway colon cancer problem, are painfully low. Given Imaging is hoping its newly approved Pillcam Colon will take away the fear factor for patients and increase diagnostic success.

Boston Scientific Corporation has received U.S. FDA 510(k) clearance and CE Mark approval for the Guidezilla™ Guide Extension Catheter and … continue reading “FDA/CE Nod And Launch For Boston Sci’s Guidezilla™ Guide Extension Catheter”