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Saved

Topic: FDA Cleared

article icon article
FDA FDA Cleared Spine

ChoiceSpine announces FDA clearance and clinical use of Blackhawk Ti Cervical Spacer System

ChoiceSpine, a spinal device company based in Knoxville, USA, has announced that it has received […]

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FDA Cleared MedTech

FDA clears Olympus airway mobilescopes

Olympus (TYO:7733) today said it received FDA clearance for its line of airway mobilescopes. The mobilescopes […]

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FDA FDA Cleared MedTech

Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system

Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes […]

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FDA Cleared MedTech Respiratory

Getinge wins 3 FDA clearances for ventilators

Getinge announced today that it received FDA 510(k) clearance for three products to expand its […]

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CE Mark FDA Cleared Robotics

NovaSignal launches the NovaGuide 2 

NovaSignal has announced the launch of the NovaGuide 2 platform, which provides clinical teams with […]

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FDA Cleared MedTech

Orthofix 3D-printed titanium cervical spacer system receives clearance

Orthofix Medical has announced the US Food and Drug Administration (FDA) has given 510(k) clearance […]

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FDA Cleared Imaging Surgery

Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module for Enhanced Surgical Visualization

Surgeons Gain Access to Real-Time Intraoperative Visual Data and Images to Improve Patient Outcomes BOSTON, April […]

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Biotech FDA Cleared MedTech

Helius Medical’s device gets FDA all clear to stimulate the brain via the tongue

What’s the best way to stimulate the brain? For Helius Medical Technologies, it’s through the […]

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FDA Cleared Imaging MedTech

Digital X-ray company Nanox scores first FDA clearance

Israeli imaging startup Nanox has landed FDA clearance for its single-source digital X-ray Nanox.ARC, the […]

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FDA Cleared MedTech Neuro

Tigertriever receives FDA clearance after ISC presentation

Rapid Medical has announced the US Food and Drug Administration (FDA) clearance of its Tigertriever revascularisation device […]

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FDA Cleared MedTech

FDA approves inhaled pulmonary hypertension treatment from United Therapeutics

United Therapeutics (NSDQ:UTHR) announced today that it received FDA clearance for its Tyvaso inhalation solution […]

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FDA Cleared Implantables MedTech

FDA clears NGMedical cervical cage

NGMedical yesterday said it received FDA clearance for its anatomically shaped cervical interbody Bee HA. […]

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FDA Cleared MedTech Patient Monitoring

Glytec launches new insulin management system

Glytec announced today that it introduced the latest version of its eGlycemic Management System (eGMS) […]

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FDA Cleared MedTech Patient Monitoring

Oxford spinoff receives De Novo clearance for video-based vitals monitoring software

Oxford University spinoff Oxehealth has received an FDA De Novo clearance for software that can […]

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FDA Cleared MedTech Neuro

MagVenture introduces MagVenture Flow Arm use in non-invasive brain stimulation 

MagVenture has introduced the MagVenture Flow Arm — a patent-pending, clinical positioning system to optimise […]

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FDA Cleared MedTech Spine

FDA clears Life Spine Prolift Wedge expandable spacer system

Life Spine announced today that it received FDA clearance for its Prolift Wedge expandable spacer […]

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FDA Cleared Imaging MedTech Spine

Fusion Robotics receives FDA clearance for spinal navigation and robotics system

Fusion Robotics has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) […]

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FDA Cleared Imaging MedTech

ControlRad Select imaging system gains FDA market clearance

ControlRad has announced US Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select, […]

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FDA Cleared MedTech Robotics

Aesculap Aeos robotic digital microscope receives FDA clearance 

Aesculap has announced its receipt of 510(k) clearance from the US Food and Drug Administration […]

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FDA Cleared MedTech Robotics

Origami Surgical gains FDA clearance for robotic suturing devices

  Origami Surgical today announced that the FDA has granted 510(k) clearance for three new […]

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FDA Cleared Neuro Pain Management

FDA clears Neurolief’s noninvasive neuromod tech to treat migraines

Neurolief today announced that it received FDA approval for its Relivion noninvasive neuromodulation system to […]

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FDA Cleared Imaging Robotics

Fusion Robotics wins FDA clearance for 3D imaging robotic targeting system

Fusion Robotics this week announced that it has received FDA 510(k) clearance for its robotics […]

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FDA Cleared Implantables Orthopedic

Conformis soars on news of FDA clearance

Conformis (NSDQ:CFMS) recently received FDA 510(k) clearance for its ITotal Identity cruciate-retaining knee replacement system. According […]

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FDA Cleared MedTech Spine

NGMedical receives FDA clearance for cervical Bee cage

NGMedical has announced that its titanium cervical Bee cage has received clearance from the US […]

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FDA Cleared Neuro Vascular

Vesalio receives peripheral FDA clearance and CE mark 

Vesalio has announced in a company press release that it has received 510(k) clearance from […]

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FDA Cleared Implantables Surgery

BlackArmour anterior cervical plate launched in the US market

icotec ag has announced the US market release of its BlackArmor carbon/PEEK implants. According to […]

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FDA Cleared MedTech Respiratory

FDA clears lightweight Inovytec ventilators

  Inovytec has announced that the FDA has granted FDA 510(k) clearance for its Ventway […]

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FDA Cleared Imaging Neuro

Longeviti announces FDA clearance of its ClearFit implant 

Longeviti Neuro Solutions has announced the 510(k) clearance by the US Food and Drug Administration […]

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FDA Cleared Orthopedic Spine

Spinal Elements receives FDA clearance for Luncent XP-Curved expandable TLIF device

Spinal Elements has announced that it has received clearance from the US Food and Drug […]

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FDA Cleared Orthopedic Spine

Inspired Spine receives FDA clearance for Trident SI Joint Screw System 

Inspired Spine has announced that its Trident SI Joint Screw System, for use in the […]

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FDA Cleared Orthopedic Robotics

J&J Wins Clearance for Velys Robotic-Assisted Solution

Johnson & Johnson’s Depuy Synthes unit has won FDA clearance for the Velys Robotic-Assisted Solution. […]

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Drug-delivery FDA Cleared

Eitan Medical lands FDA clearance for infusion pump system upgrade

Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to […]

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FDA Cleared Orthopedic Surgery

Cios Flow Mobile C-Arm from Siemens FDA Cleared

Siemens Healthineers just announced FDA clearance to introduce its Cios Flow mobile C-arm in the […]

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Biotech FDA Cleared Surgery

ClearMind Biomedical receives FDA clearance for neuroendoscope

ClearMind Biomedical has announced 510(K) US Food and Drug Administration (FDA) clearance for its Axonpen […]

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FDA Cleared Neuro Vascular

Rapid Medical receives FDA clearance for steerable neurovascular guidewire

Rapid Medical have announced its Drivewire novel guidewire with a steerable distal top, has received […]

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FDA Cleared Surgery Vascular

FDA clears Rapid Medical steerable neurovascular guidewire

Rapid Medical announced today that it received FDA clearance for its Drivewire guidewire for aiding in […]

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Cardiology FDA Cleared Patient Monitoring

Biotronik wins FDA clearance for cardiac monitor sensor

Biotronik today announced FDA clearance of its Vital Data Sensor, designed to identify body temperature increases […]

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FDA Cleared Robotics Surgery

Corindus wins FDA clearance for robotic surgery automation tech

Corindus Vascular Robotics announced today that it launched a new set of automated robotic movements in […]

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AI FDA Cleared Orthopedic

FDA clears Zebra Medical Vision’s X-ray modeling AI for orthopedic surgery planning

The artificial intelligence developer Zebra Medical Vision has received its seventh clearance from the FDA […]

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Original post by Spinal News International

Written by: Editor

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