Next-generation Hydrogel spacer offers enhanced visibility via CT Scan to optimize treatment planning for patients undergoing radiation for prostate cancer. … continue reading “U.S. Launch for Boston Scientific SpaceOAR Vue™ Hydrogel”
Products
FDA Says Yes to 130 Per Hour SARS-CoV-2 Test
in vitro diagnostics company, Ortho Clinical Diagnostics has announced that the U.S. FDA has accepted its Emergency Use Notification (EUN) … continue reading “FDA Says Yes to 130 Per Hour SARS-CoV-2 Test”
Chronic Disease Management “Chatbot” Offers a Vision of Future
Nori Health launches CE-certified iPhone app to guide chronic bowel patients. Background Globally more than half of adults are believed … continue reading “Chronic Disease Management “Chatbot” Offers a Vision of Future”
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”
CE Mark for Medovate SAFIRA® Single-Handed Regional Anaesthesia Device
Anaesthesia and airway management pioneer in critical care and surgery, Medovate, has received CE Mark Approval for its game-changing medical … continue reading “CE Mark for Medovate SAFIRA® Single-Handed Regional Anaesthesia Device”
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”
Medtronic Launches Adaptix™ Interbody System, First Navigated Titanium Cage with Titan nanoLOCK™ Surface Technology
Medtronic plc, has chosen the North American Spine Society (NASS) annual meeting at which to announce the U.S. launch of … continue reading “Medtronic Launches Adaptix™ Interbody System, First Navigated Titanium Cage with Titan nanoLOCK™ Surface Technology”
Two New FDA-Approved Bladder and Bowel Control Therapies
Medtronic plc, has received approval from the US FDA for its InterStim™ Micro neurostimulator and InterStim™ SureScan™ MRI leads. Background … continue reading “Two New FDA-Approved Bladder and Bowel Control Therapies”
CMS Approval for SINUVA® Sinus Implant
Intersect ENT®, Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, has gained Centers … continue reading “CMS Approval for SINUVA® Sinus Implant”
CE Mark for Ortho’s COVID-19 IgG Antibody Test
A few weeks ago we reported that Ortho Clinical Diagnostics had seen its COVID-19 total antibody test CE marked. Now … continue reading “CE Mark for Ortho’s COVID-19 IgG Antibody Test”
Now Ortho’s COVID Antibody Test Gains CE Mark
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics has announced that its COVID-19 total antibody test received CE … continue reading “Now Ortho’s COVID Antibody Test Gains CE Mark”
FDA Emergency Use Authorization for Ortho’s COVID-19 Total Antibody Test
The U.S. FDA has granted Emergency Use Authorization to Ortho Clinical Diagnostics’ total antibody assay for COVID-19 – the VITROS® … continue reading “FDA Emergency Use Authorization for Ortho’s COVID-19 Total Antibody Test”
Revivent TC Less Invasive Ventricular Enhancement Therapy CE Mark Extended to 2024
BioVentrix, Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, has announced the extension … continue reading “Revivent TC Less Invasive Ventricular Enhancement Therapy CE Mark Extended to 2024”
CE Mark for “World First” Single-Use Duodenoscope, EXALT Model D
Boston Scientific Corporation has gained the CE Mark and initiated a limited market release of the EXALT™ Model D Single-Use (disposable) … continue reading “CE Mark for “World First” Single-Use Duodenoscope, EXALT Model D”