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”
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Major New UK Study Highlights Risks of Post-Surgery Disc Prolapse
Data from one of the world’s largest spine studies identifies reherniation risk factors after prolapsed disc surgery. Background Surgical discectomy … continue reading “Major New UK Study Highlights Risks of Post-Surgery Disc Prolapse”
Medtronic DTM™ Spinal Cord Stimulation Therapy Outperforms Conventional SCS Therapy for Back Pain Relief at 12 Months
Statistically significant 12-month results from a large, multicenter randomized controlled trial confirm 84% Back Pain Responder Rate and 69% Profound … continue reading “Medtronic DTM™ Spinal Cord Stimulation Therapy Outperforms Conventional SCS Therapy for Back Pain Relief at 12 Months”
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”
First Patients in Europe Treated with Biosense Webster VARIPULSE® AF Catheter
Johnson & Johnson Medical Devices Companies’ Biosense Webster, Inc., says the first patients have been enrolled and treated in its … continue reading “First Patients in Europe Treated with Biosense Webster VARIPULSE® AF Catheter”
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”
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”
First Two Patients for SELUTION SLR™ Sirolimus Drug Eluting Balloon Study
The first two patients have been enrolled in the PRISTINE registry with MedAlliance’s SELUTION SLR™ 018 Drug Eluting Balloon (DEB) … continue reading “First Two Patients for SELUTION SLR™ Sirolimus Drug Eluting Balloon Study”
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”
Aerin to Invest in Studies and New Products with $48M New Equity
Aerin Medical, a privately held medical device company focused on non-invasive procedures for treating nasal airway conditions, has closed a … continue reading “Aerin to Invest in Studies and New Products with $48M New Equity”
Largest Therapeutic Study Says Cala Trio Essential Tremor Therapy Safe and Effective
Bioelectronic medicine company, Cala Health, Inc. says its landmark PROspective study for SymPtomatic relief of Essential tremor with Cala Therapy (PROSPECT), demonstrates safe and effective … continue reading “Largest Therapeutic Study Says Cala Trio Essential Tremor Therapy Safe and Effective”
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”
Cases Resume in BioCardia CardiAMP Heart Trial
Cardiovascular regenerative therapies company BioCardia®, Inc., tells us it has resumed cases in the CardiAMP Heart Failure Trial. The first … continue reading “Cases Resume in BioCardia CardiAMP Heart Trial”
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”
Air Disinfection Protects Dental Practices Against COVID-19
Eschmann Technologies has launched a revolutionary air disinfection system, developed by Novaerus to help protect dentists against the spread of airborne … continue reading “Air Disinfection Protects Dental Practices Against COVID-19”
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”