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FDA
Medical Device News Magazine is a comprehensive online resource for professionals in the medical device industry. Our editorial team provides readers with the latest regulatory news and updates from the FDA, as well as insights on product approvals, recalls, and alerts.
eShunt System for Patients with Normal Pressure Hydrocephalus – CereVasc Update
Representing the first minimally invasive treatment for NPH, the eShunt device offers the potential to result in benefits over the current treatment, a half-century-old neurosurgical procedure associated with frequent failure, infection risk, and high costs.
ASCENT ASD US IDE Trial Update from atHeart Medical
"As we initiate the second phase, our team is focused on adding clinical sites across the U.S. and expanding internationally to include several enrolling sites in France," advises Laurent Grandidier, CEO of atHeart Medical
ClariVy Cervical IBF System Receives FDA Clearance
“The ClariVy Cervical IBF System is the first in a series of differentiated interbody systems being developed by VySpine,” said Tom McLeer, CEO of VySpine.
Chemence Medical Receives FDA Clearance for new Exofin® Precision Pen
“Our continued mission with Exofin products is to enable doctors to achieve the perfect line every time,” said Jeff Roberson, President of Chemence Medical.
Bedfont Scientific Ltd receives FDA clearance for NObreath® FeNO monitor
The NObreath®, which conforms to ATS and ERS guidelines1, is a portable, non-invasive device for the measurement of Fractional Exhaled Nitric Oxide (FeNO) in human breath.
FDA Accepts Label Update for Plasma IQ, the First FDA-Cleared Handheld Plasma Energy Device
The removal of this specific contraindication was due in part to a compilation of literature provided to the FDA showing the safety and efficacy of the ablative device on skin tissue, particularly around the eye area. This label update allows Suneva to address treatment around the eye with patients in the United States.
Insulet Announces FDA Clearance of its Omnipod® 5 Automated Insulin Delivery System
Omnipod 5 is the first tubeless automated insulin delivery (AID) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.
Medtronic Reports FDA Approval of Spinal Cord Stimulation Therapy for Treating Chronic Pain Resulting from Diabetic Peripheral Neuropathy
This new indication enables us to apply Medtronic's more than 40 years of proven SCS experience, as well as the company's deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients.
Cook Medical Receives FDA Breakthrough Designation for New Drug-eluting Stent
The Breakthrough Device designation is granted for devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
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