FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease

The U.S. FDA has granted Breakthrough Device Designation to Cala Trio™ for the treatment of action tremors in the hands … continue reading “FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease”

DynaNail® Becomes First Sustained Compression Internal Fixation Device to Gain CMS Code

NiTiNOL-based DynaNail products approved for use with new ICD-10-PCS code. This new classification will enable healthcare providers and payers to … continue reading “DynaNail® Becomes First Sustained Compression Internal Fixation Device to Gain CMS Code”

Legalists Point to Surgical Robot Training and Technical Failings

Law firm Bernstein Liebhard LLP has issued a press release that brings us up to date, pointing in particular to a piece of research that suggests 30% of robotic surgery complications using Intuitive’s da Vinci system, as reported on the FDA’s MAUDE database, were either a result of operator error or technical failure of the robotic system itself.