FDA Cleared Archives - Page 4 of 10 - TMG Pulse

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FDA Cleared MedTech Neuro

FDA clears Magstim advanced transcranial magnetic stimulation platform

Magstim announced today that it received FDA 510(k) clearance for its Horizon 3.0 transcranial magnetic stimulation […]

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FDA Cleared MedTech Wearables

Northwestern spinout Sibel Health scores FDA clearance for patient monitoring system

The system includes two sensors and a digital platform.

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FDA Cleared MedTech

FDA clears expanded indications for BD’s Rotarex atherectomy system

BD this week announced that it has received FDA 510(k) clearance for expanded indications for […]

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AI FDA Cleared MedTech

FDA offers expanded clearance for DreaMed’s AI-based support system for type 2 diabetes

DreaMed Diabetes AI announced today that it received FDA clearance that expands its platform’s target […]

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FDA Cleared Imaging MedTech

FDA clears ‘major’ CT advance out of Siemens Healthineers

FDA announced today that it has cleared Siemens Healthineers’ Naeotom Alpha, describing the device as […]

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Digital Health FDA Cleared MedTech

FDA clears Koya Medical’s active compression therapy on the go

Koya Medical said today that it has won FDA 510(k) clearance for its Dayspring Lite […]

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Cardiology FDA Cleared Imaging MedTech

Zebra Medical Vision lands FDA clearance for tool to detect cardiovascular disease

This comes just a month after news broke Nanox was set to acquire Zebra Medical Vision.

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FDA Cleared

Welldoc wins expanded FDA clearance for BlueStar insulin dosing platform

Welldoc announced today that it received another FDA 510(k) clearance for its BlueStar diabetes treatment platform. […]

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FDA Cleared MedTech Spine

joimax receives FDA clearance to market 3D-printed titanium cages in the USA

joimax has received FDA clearance to market the EndoLIF Delta-Cage and EndoLIF DoubleWedge-Cage—both of which are […]

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AI FDA Cleared Imaging MedTech Neuro

InTRAvent wins FDA 510(k) clearance for Solopass bedside neuro-navigation device

InTRAvent has announced FDA 510(k) clearance of its Solopass system for assisting frontal placement of […]

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FDA Cleared MedTech Neuro

FDA clears NeuroOne’s Evo sEEG electrode

NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode […]

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FDA Cleared MedTech

EXALT Model B Single-Use Bronchoscope: Interview with Dave Pierce, Boston Scientific

Boston Scientific recently announced FDA clearance of the EXALT Model B single-use bronchoscope, intended for […]

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FDA Cleared MedTech Neuro

NeuroOne Medical Technologies gains FDA 510(k) clearance for Evo SEEG electrode

NeuroOne Medical Technologies—a company focused on improving surgical care options and outcomes for patients with […]

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FDA Cleared MedTech Spine

MiRus receives FDA clearance for IO Expandable Lumbar Interbody

MiRus has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance […]

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FDA Cleared MedTech Robotics Surgery

FDA clears expanded machine vision capabilities for Asensus Surgical’s robotic surgery system

Asensus Surgical (NYSE American: ASXC) announced today that FDA has cleared next-gen augmented intelligence capabilities on […]

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FDA Cleared MedTech Orthopedic

Tyber Medical’s anatomical plating system wins FDA clearance

Tyber Medical today said it received FDA 510(k) clearance for its expanded line of anatomical […]

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FDA Cleared MedTech Spine

FDA clears MiRus expandable lumbar system

MiRus today said it received FDA 510(k) clearance for its IO expandable lumbar interbody. Marietta, […]

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FDA Cleared MedTech Orthopedic

Fuse Medical wins FDA 510(k) clearance for Sterizo knee system

Fuse Medical announced today that it received FDA 510(k) clearance for its tibial revision knee system […]

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FDA Cleared MedTech Orthopedic

Shoulder Innovations wins FDA clearance for InSet Reverse shoulder arthroplasty system

Shoulder Innovations this week announced that it has received FDA 510(k) clearance for its InSet […]

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FDA Cleared MedTech Orthopedic Robotics

FDA clears Zimmer Biomet’s Rosa Hip personalized robotic system

Zimmer Biomet (NYSE:ZBH) today announced that it received FDA 510(k) clearance for its Rosa Hip system […]

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FDA Cleared MedTech

FDA clears Able Medical’s Mach screw clip system

Able Medical Devices recently announced that its Mach screw clip system has received FDA 510(k) […]

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FDA Cleared Imaging MedTech

Globus Medical Excelsius3D imaging system wins FDA clearance

Globus Medical recently announced that it has received FDA 510(k) clearance for its Excelsius3D intelligent […]

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FDA Cleared MedTech Surgery

FDA clears Boston Scientific’s Exalt Model B single-use bronchoscope

Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its Exalt Model B […]

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FDA Cleared Spine

Camber Spine receives FDA clearance for SPIRA-P and SPIRA-T lumbar spacer technologies

Camber Spine has received US Food and Drug Administration (FDA) 510(k) clearance for both its […]

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AI Cardiology FDA Cleared

Abbott receives FDA clearance for AI-powered heart imaging software

Abbott has received clearance from the FDA for its imaging software that uses artificial intelligence to provide doctors a better view of blood flow and blockages in heart vessels.

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FDA Cleared MedTech

FDA clears TransMedics OCS Lung System

TransMedics (NSDQ:TMDX) has won FDA clearance of its OCS Lung System to provide hypothermic flushing, storage […]

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AI FDA Cleared

Volpara Health lands additional FDA clearance for breast cancer detection product

This marks the fourth clearance for Volpara’s breast health platform since its original authorization back in 2010.

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FDA Cleared MedTech Robotics Surgery

FDA clears articulating instruments for Asensus Surgical’s robotic system

Asensus Surgical (NYSE American: ASXC) announced today that FDA has cleared 5 mm diameter articulating instruments […]

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Cardiology FDA Cleared MedTech

FDA clears Medtronic’s AI algorithms for cardiac monitoring

Medtronic (NYSE:MDT) announced today that the FDA cleared two of its AccuRhythm AI algorithms for use […]

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FDA Cleared Imaging Ophthalmology

Fujifilm Eyes Better Patient Outcomes with FDA 510(k) Clearance for Endosurgical Image Enhancement Technology

Real-time visualization of hemoglobin oxygen saturation (StO2) levels in tissue could help surgeons better identify potential ischemia.

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FDA Cleared Neuro

Omniscient Neurotechnology launches Quicktome brain-mapping platform following FDA clearance

Omniscient Neurotechnology has received US Food and Drug Administration (FDA) 510(k) clearance for Quicktome—a digital […]

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Digital Health FDA Cleared MedTech

Dexcom gets FDA nod for its new API integration

Third-party digital health companies can now integrate Dexcom’s continuous glucose monitoring data into their platforms […]

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FDA Cleared MedTech

FDA clears Stryker biodegradable subacromial balloon spacer

Stryker (NYSE:SYK) this week announced that it received FDA 510(k) clearance for its balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears.

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FDA Cleared Imaging MedTech

Hyperfine, Inc., Creator of the First FDA-Cleared Portable MRI Device, and Liminal Sciences, Inc. To Be Listed on Nasdaq Through a Business Combination With HealthCor Catalio Acquisition Corp.

The transaction will combine Hyperfine, creator of the innovative Portable MR Imaging System, Swoop™, with […]

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FDA Cleared Spine Surgery

SeaSpine announces FDA clearance of 7D Surgical Percutaneous Spine Module

SeaSpine has announced that it has received FDA 510(k) clearance of its 7D Percutaneous Spine […]

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FDA FDA Cleared MedTech

CoreLink announces FDA clearance for F3D Corpectomy Vertebral Body Replacement System

CoreLink has announced the commercial launch and 510(k) clearance from the US Food and Drug […]

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AI FDA Cleared Spine

Medtronic receives FDA clearance for patient-specific UNi Rods

Medtronic has announced that it has received US Food and Drug Administration (FDA) clearance of […]

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FDA Cleared MedTech Spine

Medtronic receives FDA clearance for patient-specific UNiD Rods

Medtronic has announced that it has received US Food and Drug Administration (FDA) clearance of […]

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Biotech FDA Cleared MedTech

Edwards’ low-BP prediction software gains FDA clearance

Edwards Lifesciences (NYSE:EW) has announced that its Acumen hypotension prediction index (HPI) software has […]

Topic: FDA Cleared

FDA clears Magstim advanced transcranial magnetic stimulation platform

Northwestern spinout Sibel Health scores FDA clearance for patient monitoring system

FDA clears expanded indications for BD’s Rotarex atherectomy system

FDA offers expanded clearance for DreaMed’s AI-based support system for type 2 diabetes

FDA clears ‘major’ CT advance out of Siemens Healthineers

FDA clears Koya Medical’s active compression therapy on the go

Zebra Medical Vision lands FDA clearance for tool to detect cardiovascular disease

Welldoc wins expanded FDA clearance for BlueStar insulin dosing platform

joimax receives FDA clearance to market 3D-printed titanium cages in the USA

InTRAvent wins FDA 510(k) clearance for Solopass bedside neuro-navigation device

FDA clears NeuroOne’s Evo sEEG electrode

EXALT Model B Single-Use Bronchoscope: Interview with Dave Pierce, Boston Scientific

NeuroOne Medical Technologies gains FDA 510(k) clearance for Evo SEEG electrode

MiRus receives FDA clearance for IO Expandable Lumbar Interbody

FDA clears expanded machine vision capabilities for Asensus Surgical’s robotic surgery system

Tyber Medical’s anatomical plating system wins FDA clearance

FDA clears MiRus expandable lumbar system

Fuse Medical wins FDA 510(k) clearance for Sterizo knee system

Shoulder Innovations wins FDA clearance for InSet Reverse shoulder arthroplasty system

FDA clears Zimmer Biomet’s Rosa Hip personalized robotic system

FDA clears Able Medical’s Mach screw clip system

Globus Medical Excelsius3D imaging system wins FDA clearance

FDA clears Boston Scientific’s Exalt Model B single-use bronchoscope

Camber Spine receives FDA clearance for SPIRA-P and SPIRA-T lumbar spacer technologies

Abbott receives FDA clearance for AI-powered heart imaging software

FDA clears TransMedics OCS Lung System

Volpara Health lands additional FDA clearance for breast cancer detection product

FDA clears articulating instruments for Asensus Surgical’s robotic system

FDA clears Medtronic’s AI algorithms for cardiac monitoring

Fujifilm Eyes Better Patient Outcomes with FDA 510(k) Clearance for Endosurgical Image Enhancement Technology

Omniscient Neurotechnology launches Quicktome brain-mapping platform following FDA clearance

Dexcom gets FDA nod for its new API integration

FDA clears Stryker biodegradable subacromial balloon spacer

Hyperfine, Inc., Creator of the First FDA-Cleared Portable MRI Device, and Liminal Sciences, Inc. To Be Listed on Nasdaq Through a Business Combination With HealthCor Catalio Acquisition Corp.

SeaSpine announces FDA clearance of 7D Surgical Percutaneous Spine Module

CoreLink announces FDA clearance for F3D Corpectomy Vertebral Body Replacement System

Medtronic receives FDA clearance for patient-specific UNi Rods

Medtronic receives FDA clearance for patient-specific UNiD Rods

Edwards’ low-BP prediction software gains FDA clearance