April 17, 2015 by Val Kennedy
Abbott said it received FDA approval for a new, budget-priced glucose monitor that can be purchased without a prescription.
The over-the-counter FreeStyle Precision Neo meter will sell in the $22 to $28 range, with a package of 25 test strips costing between $14 and $17, the company said. Read more
April 14, 2015 by Brad Perriello
Medtronic’s entry into the leadless pacemaker market won CE Mark approval in the European Union, the company said today, touting it as the world’s smallest pacemaker.
The Micra transcatheter pacing system, which at ⅒ the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle to deliver single-chamber pacing, Medtronic said. Read more
April 17, 2015 by Mark Hollmer
Conventus Orthopaedics, with an FDA clearance in hand, plans a gradual rollout of a new device designed to help repair shoulder fractures in a less invasive way.
Conventus said it won 510(k) clearance from the FDA for its Conventus PH, a nitinol device that’s designed to expand inside the bone as an internal scaffold to prevent collapse of a shoulder fracture. Read more
April 20, 2015 by Brad Perriello
The FDA last week approved the 1st implant designed to correct near vision loss in patients who have not had cataract surgery, the Kamra inlay made by AcuFocus.
The Kamra device, an ultra-thin, opaque ring that’s implanted under the corneal flap of the non-dominant eye in presbyopic patients, is designed to reduce the aperture of the eye and increase the depth of focus. Read more
April 20, 2015 by Mark Hollmer
CardiacAssist last week said it nailed down CE Mark approval in the European Union for a cannula designed to both drain and re-infuse blood during life support procedures.
The Pittsburgh-based company said the Class 3 CE Mark covers its Protek Duo veno-venous cannula, a thin tube that’s inserted into a jugular vein to drain fluid and reinfuse blood during life support procedures for patients with acute respiratory distress syndrome. Read more