Regulatory

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”

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”

Stentys, developer of the world’s first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), has received approval to … continue reading “Stentys Self-Apposing Stent Gets Broader Coronary Indications”

CryoLife, Inc.has announced that it has received U.S. FDA premarket approval for its new Sologrip® minimally invasive laser fiber-optic delivery system, a single-use, disposable handset designed for use with the Company’s Cardiogenesis transmyocardial revascularization system.

Abbott has announced that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the XIENCE Xpedition™ Everolimus Eluting Coronary … continue reading “Japanese Approval For Abbott’s XIENCE Xpedition™ Drug Eluting Stent”

Tyrx Inc’s, Inc. fully Resorbable AIGISRx® R Antibacterial Envelope for use with pacemakers and implantable cardioverter defibrillators has gained U.S. FDA clearance.

NeuroMetrix, Inc., a medical device company focused on the treatment of the neurological complications of diabetes, reported that the SENSUS Pain Management System has become the first transcutaneous electrical nerve stimulator to receive FDA 510(k) clearance for use during sleep.

CorMedix Inc. has gained CE Mark approval for Neutrolin®, a catheter lock solution for patients with central venous catheters on hemodialysis secondary to advanced chronic kidney disease.

Stockholm based Episurf Medical has gained CE Mark certification for its personalised Episealer® implant for the treatment of femoral condyle cartilage defects in the knee.

Integra LifeSciences Holdings Corporation has received European CE Mark for its Integra® Smart Cervical Solution, a device for treating degenerative diseases of the cervical spine that require stabilization and fusion of two or more cervical vertebrae.