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”
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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”
Deltex Steps Up COVID-19 Support as Haemodynamic Monitoring Features
With no cure in sight, management of critically ill COVID-19 patients focuses on supportive care. Deltex says its haemodynamic monitoring … continue reading “Deltex Steps Up COVID-19 Support as Haemodynamic Monitoring Features”
Rezūm™ Water Vapor BPH Therapy Effective After Five Years
New clinical study results say the Rezūm System provided significant, sustained improvement of lower urinary tract symptoms (LUTS) and quality of … continue reading “Rezūm™ Water Vapor BPH Therapy Effective After Five Years”
First Patient in SELUTION SLR™ Study for AV Fistula
MedAlliance has announced enrollment of the first patient in the SAVE* study utilizing their novel sirolimus-eluting balloon. The device is … continue reading “First Patient in SELUTION SLR™ Study for AV Fistula”
Flu Respirator or Surgical Face Mask?
Unlike simple face masks or surgical masks, respiratory masks protect against aqueous and oily aerosols, smoke and fine dust. Clinova … continue reading “Flu Respirator or Surgical Face Mask?”
First Scoring Guidelines Validated for WatchPAT™ Sleep Apnea Diagnostic
Respiratory Sleep Disorder specialist, Itamar Medical Ltd. has announced publication of results of the COMPASS study. The upshot sees validated … continue reading “First Scoring Guidelines Validated for WatchPAT™ Sleep Apnea Diagnostic”
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”
Promise for Emboliner™ Embolic Protection Catheter as Safepass 2 Study Completes Enrollment
Emboline™, Inc., developer of total embolic protection technology for transcatheter aortic valve replacement (TAVR), has announced completion of enrollment in its … continue reading “Promise for Emboliner™ Embolic Protection Catheter as Safepass 2 Study Completes Enrollment”
Newly Cleared Cranial Robotic System Sees First Paediatric Deployment
Phoenix Children’s Hospital, is the first health system in the U.S. to receive and deploy the newly FDA-cleared Medtronic Stealth … continue reading “Newly Cleared Cranial Robotic System Sees First Paediatric Deployment”