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Saved

Topic: IDE

article icon article
Cardiology CE Mark IDE

Medtronic wins CE mark for ablation device, invests in heart failure monitoring company

Medtronic said it has received Europe’s CE mark for its Affera system that integrates pulsed […]

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Clinical Study FDA IDE

Vivasure wins FDA IDE approval, receives €30M from Haemonetics

Vivasure Medical announced today that it received FDA investigational device exemption (IDE) to advance a clinical […]

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Clinical Trial IDE Spine

TOPS facet joint replacement demonstrates significant improvements versus fusion in IDE trial

Premia Spine has announced the publication of two-year outcomes from the TOPS facet joint replacement […]

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IDE Robotics Surgery

Virtual Incision’s MIRA Completes FDA IDE Study

Virtual Incision Corporation, a medical device company developing a miniaturized robotic-assisted surgery (RAS) system, has […]

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FDA Approved IDE Oncology

FDA approves HistoSonics IDE trial for sonic beam therapy that treats renal tumors

HistoSonics announced today that it received FDA approval for an investigational device exemption (IDE) trial of […]

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Drug-delivery IDE MedTech

MedAlliance picks up FDA IDE nod for drug-eluting balloon

MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE). […]

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Diagnostics IDE Oncology

Burning Rock wins FDA breakthrough nod for multi-cancer blood test

Burning Rock (Nasdaq:BNR) announced today that the FDA granted breakthrough device designation to its OverC blood test. […]

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Digital Therapeutics FDA IDE

Click wins FDA breakthrough designation for prescription digital migraine therapy

Dive Brief: Click Therapeutics has received breakthrough device status for its prescription digital migraine therapy. The Food […]

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FDA IDE Neuro

Sinaptica Therapeutics obtains FDA Breakthrough Device Designation for Alzheimer’s treatment

Cambridge-based Sinaptica Therapeutics, a company providing electromagnetic treatment for patients with neurodegenerative diseases, announced its […]

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FDA IDE Radiology

Attune Medical wins FDA IDE nod to evaluate ensoETM in radiofrequency ablation procedures

Attune Medical announced today that the FDA granted investigational device exemption (IDE) to study the company’s […]

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IDE Neuro Spine

Gimer Medical granted IDE approval for spinal cord stimulation system

Gimer Medical today announced that the company’s spinal cord stimulation (SCS) system was granted conditional […]

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FDA IDE Neuro

CereVasc announces first treatment in US trial evaluating eShunt for normal-pressure hydrocephalus

CereVasc today announced completion of the first eShunt procedure in the USA as part of […]

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Clinical Trial Drug-delivery IDE

First U.S. patient enrolled in MedAlliance Selution SLR drug-eluting balloon trial

MedAlliance announced today that the first U.S. patient was enrolled in a U.S. clinical trial […]

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FDA IDE MedTech

FDA’s breakthrough medical device designations tally nears 700

The US Food and Drug Administration has granted almost 700 designations over the past seven […]

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Catheters FDA IDE

MedAlliance wins second FDA IDE nod for drug-coated balloon

MedAlliance announced today that received conditional FDA investigational device exemption (IDE) for its Selution SLR […]

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FDA IDE Neuro

CereVasc announces US FDA approval for second IDE study of eShunt system

CereVasc announced today that the US Food and Drug Administration (FDA) has approved an investigational […]

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IDE Robotics Surgery

Virtual Incision & NASA to Bring Robotic-Assisted Surgery to Space

Virtual Incision is going where few if any robotic-assisted surgical (RAS) devices have ever gone […]

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Clinical Trial IDE Spine

First US surgeries performed in BalancedBack total joint replacement IDE trial

3Spine has announced completion of the first series of US surgeries in the BalancedBack total […]

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Clinical Trial IDE Neuro

NeuroVasc announces first patient treated in clinical trial evaluating novel stent retriever

NeuroVasc Technologies recently announced that the first patient has been treated in its US investigational […]

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FDA IDE Radiology

Varian wins FDA IDE for Flash radiation therapy

Varian announced today that it received FDA investigational device exemption IDE to advance its Flash clinical […]

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Clinical Trial IDE Urology

Neuspera Medical announces second phase of SANS-UUI clinical trial with Nuvella system 

Neuspera Medical recently announced it will begin enrolment in its pivotal clinical trial, SANS-UUI—a single-arm […]

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Clinical Trial IDE Neuro

Neuros Medical announces completion of 90-day primary endpoints in QUEST pivotal trial

Neuros Medical has announced the completion of its QUEST pivotal trial’s 90-day primary endpoints, according […]

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Drug-delivery FDA IDE

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR […]

Original post by MedTech Dive

Written by: Susan Kelly

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