ABT unveils OTC glucose meter | Regulatory news for the week of April 20, 2015

Abbott unveils over-the-counter glucose meter

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

Medtronic's Micra leadless pacemaker wins EU approval

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

FDA clears Conventus PH shoulder cage

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

FDA approves AcuFocus Kamra inlay

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

Cardiac Assist wins CE Mark for emergency cannula

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

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