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”

FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation

Johnson & Johnson Medical Devices Companies have announced the U.S. FDA approval of Biosense Webster, Inc.’s THERMOCOOL SMARTTOUCH® SF Ablation … continue reading “FDA Approval for Biosense Webster THERMOCOOL SMARTTOUCH® SF Ablation Catheter for Persistent Atrial Fibrillation”

Xfree® Extraction-Free Direct RT-PCR Test: FDA Emergency Use Authorization Submission

Molecular diagnostics solutions company, BioGX has announced the FDA Emergency Use Authorization (EUA) submission of an extraction-free, direct sample addition … continue reading “Xfree® Extraction-Free Direct RT-PCR Test: FDA Emergency Use Authorization Submission”

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”