All Articles in: Approval/Clearance

FDA Approves Medtronic CoreValve™ Evolut™ Pro Transcatheter ValveMarch 24, 2017

First-ever data at ACC.17 confirms safety and efficacy of new self-expanding, recapturable heart valve at 30-days with high survival, low stroke and minimal paravalvular leak

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FDA Clears PEEK Polymer CAD/CAM Dental Device for Long-Term Implant Borne ProstheticsMarch 22, 2017

High performance polymer dental prosthetic device can potentially enable improved patient quality of life and efficiencies compared to metal

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FDA Clears Medtronic’s Reveal LINQ™ Insertable Cardiac Monitor (ICM) with TruRhythm™ DetectionMarch 14, 2017

New system offers continuous wireless heartbeat monitoring for up to three years

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FDA Nod for Altus Spine’s Cervical Plate System

Clearance for Fuji Cervical Plate for anterior interbody fixation

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FDA Clearance for Medtronic CardioInsight™ Mapping VestFebruary 7, 2017

System “makes it easy for patients to receive precise mapping results from their providers right at their bedside”

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FDA Approval for First Balloon Expandable Stent Graft for Use in the Iliac ArteryFebruary 3, 2017

GORE® VIABAHN® VBX becomes the only device of its type to gain indication

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U.S. FDA Approval for Abbott Assurity MRI™ PacemakerFebruary 1, 2017

From the recently acquired St. Jude stable, now in Abbott’s hands, Assurity now lays claim to being the World’s smallest, longest-lasting wireless MRI-compatible pacemaker

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Chinese FDA Nod for ZipLine® Medical’s Non-Invasive ZIP® Skin Closure SystemDecember 22, 2016

Clearance will give the company access to the $543 million Chinese wound closure device market serving over 40 million procedures

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CE Mark for World’s First Sterile, Single-Use Endoscope for ColonoscopiesDecember 5, 2016

The invendoscope™ SC200 effectively means a personal endoscope for each patient

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CE Mark for Percutaneous CLI SystemNovember 16, 2016

“No option” Critical Limb Ischemia Patients may soon have an option as clever, ultrasound-guided revascularisation technology gains EU nod

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FDA Approves St. Jude Medical BurstDR™ Spinal Cord Stimulation for Chronic PainOctober 6, 2016

BurstDR stimulation targets chronic pain patients with a new therapy option designed to provide less pain, less suffering and less therapy maintenance

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CE Mark for World’s Lowest Profile Single-Port Surgery SolutionOctober 4, 2016

Fortimedix Surgical has received CE Mark approval for FMX314, the world’s first single-port surgery solution that is compatible with a standard 15mm trocar

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FDA Clearance of the invendoscopy E200 System Including the First and Only Sterile, Single-use Endoscope For ColonoscopiesSeptember 8, 2016

invendo Medical says its system is a simple, safe and effective solution to the challenges of cross-contamination and infection control

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FDA Clearance of Centric Medical™ TARSA-LINK™ Bunion SystemAugust 17, 2016

Centric Medical has announced the U.S. FDA 510(k) clearance of its TARSA-LINK Bunion Correction System, which utilizes a PEEK polymer implant

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U.S. FDA Approval for Boston Scientific’s EMBLEM™ MRI S-ICD SystemAugust 11, 2016

Approval grants MR-conditional labeling to all EMBLEM S-ICD Systems, further expanding the company’s ImageReady™ portfolio

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CE Mark for Spectranetics AngioSculptX Drug-coated ‘Scoring’ Balloon

Novel balloon catheter with nitinol “scoring” element gains CE mark

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