Aptus Endosystems lands FDA nod for abdominal aneurysm device
Aptus Endosystems said it won 510(k) clearance from the FDA for its thoracic-length HeliFX aortic anchor for repairing abdominal aortic aneurysms. The first iteration of the device earned FDA clearance – and its share of controversy – in November 2011. The latest clearance came via the watchdog agency’s de novo device review protocol. Aptus counts former Boston Scientific (NYSE:BSX) CEO James Tobin as a member of its board of directors.
K2M grabs additional scoliosis clearances
K2M said it landed additional 510(k) clearance for its Mesa Deformity, Mesa Rail Deformity, Mesa Small Stature and Mesa Rail Small Stature spinal systems to treat adolescent idiopathic scoliosis.
SuperSonic Imagine touts 510(k) for ShearWave
SuperSonic Imagine won 510(k) clearance from the FDA for the addition of a real-time, adjustable numerical scale in meters per second for ShearWave elastography on its Aixplorer ultrasound device.
Intelomed gets FDA clearance for patient monitoring device
Intelomed said it received FDA 510(k) clearance for its CVInsight patient monitoring device.
Opto Circuits’ Unetixs Vascular wins CE Mark for Revo 110
Opto Circuits said its U.S.-based subsidiary Unetixs Vascular won CE Mark approval in the European Union for its Revo 1100 peripheral vascular diagnostic system and vascular profiler.