FDAnews Device Daily Bulletin

The Centers for Medicare & Medicaid Services is planning to re-examine its coverage standards for ventricular assist devices (VAD), but any changes in the offing are still under wraps.

A Form 483 for AngioDynamics of Queensbury, N.Y., states the company distributed a range of devices with flaws or unapproved features.

Continuous intraocular pressure measurement with a contact lens sensor was safe and tolerable with repeated use, although mild adverse effects were common and the measurements were variable, researchers said.

The discovery of bacteria-resistant polymers is being hailed as a potential biomedical breakthrough that could be used to create coatings for surgical and hospital devices, reducing the risk of infection.

For amputees like John Redfield, shopping for a new pair of shoes used to be a major hassle.

A federal judge in Texas erred when he failed to give enough weight to a jury’s finding in a patent infringement case between Smith & Nephew and Kinetic Concepts, according to the U.S. Court of Appeals for the Federal Circuit.

In line with the company’s commitment to provide superior economic value to customers, Medtronic announced the U.S. launch of the CareLink Express Service.

Helix Medical is boosting its global footprint with the acquisition of a 50 percent share in Cambus Medical as of January 2013.