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Regulatory
U.S. Next? Sorin Gains Health Canada Approval for Perceval Valve
Sorin’s Sutureless Valve is in the process of undergoing U.S. FDA approval, but in the meantime is beefing up its international presence with the go-ahed in another market
FDA Clearance for Medrobotics® Flex® Robotic System
“I’ve been a surgeon since 1960 and this technology is one of the most significant operating room advances I’ve seen in decades”
First U.S. Patients for Biotronik’s Newly Approved Itrevia HF-T QP CRT-D Device
Device incorporates latest defibrillator technology, closed loop stimulation and compatibility with a quadripolar lead
CE Mark for SinuSys™ Vent-Os® Sinus Dilation System for Treatment of Frontal and Sphenoid Sinusitis
Two new devices will expand portfolio of low-pressure, self-expanding dilation devices to treat frontal and sphenoid sinusitis, in addition to maxillary disease.
Ventilation System Clearance for Breathe Technologies
Breathe Technologies has gained FDA 510(k) clearance for its Life2000 Ventilation System for people needing mechanical ventilation
Size Matters as Smith & Nephew Pulls Smaller Hip Resurfacing Components
Smaller sized Birmingham Hip Resurfacing components are being withdrawn due to heightened risk of revision surgery
CE Mark for St. Jude’s “Industry First” Neuromodulation Trial System
St. Jude Medical, Inc., has gained CE Mark approval and announced the European launch of its Invisible Trial System, an app-based and wireless neuromodulation programming system leveraging Apple™ iPod touch™ and iPad mini™ technology.
Direct Flow Medical® Names Co-principal Investigator for U.S. Pivotal Study
Transcatheter valve implantation using the novel Direct Flow “inflatable” valve has moved a step closer as the company appoints study leader
Coming Soon to an Abdomen Near You? TransEnterix Submits 510(k) Application for Surgical Robot
First patient-side robotically enhanced laparoscopic surgery platform aims for U.S. market clearance
Taking the Guesswork out of Epidural’s: FDA Clears Ultrasound Guidance System
Rivanna Medical’s Accuro™ system is the first ultrasound guidance system to provide 3D navigation to an anatomical target
FDA Clears Penumbra’s ACE64 Thrombectomy System for Stroke Treatment
Latest mechanical thrombectomy device delivers higher revascularization rates, reduced procedure time and cost
CE Mark for Abbott’s New Absorb GT1™ Stent System
New generation of Abbott’s absorbable stent line features improved access and deliverability
FDA (510k) Clearance for Magstim’s rTMS (repetitive Transcranial Magnetic Stimulation) Therapy System
Pioneering device manufacturer cleared for U.S. launch of its Rapid2 Therapy System for treatment of drug resistant Major Depressive Disorder
CE Mark for Second Generation Endostim Neurostimulation Device for GERD
Endostim’s thinner, smaller new lower esophageal sphincter stimulating device promises an improved patient experience
CE Mark for Arterial Remodeling Technologies’ Pure Bioresorbable Scaffold
Arterial Remodeling Technologies has gained CE Mark approval for its next generation drug free, pure bioresorbable scaffold used to treat coronary artery disease