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1 week ago

Zeto's New Wave EEG System Receives FDA Clearance for Enhanced Outpatient Use Zeto, Inc. has received FDA 510(k) clearance for its New Wave EEG, designed to provide efficient outpatient EEG solutions with enhanced accessibility. Explore its features!

Zeto's New Wave EEG System Receives FDA Clearance for Enhanced Outpatient Use #United_States #Raleigh #FDA_Clearance #Zeto_New_Wave #EEG_System

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1 week ago

SoloPace Introduces Innovative Temporary Pacing System for Heart Valve Procedures in the US Market SoloPace FUSION, a groundbreaking temporary pacing system, enhances patient safety and efficiency in heart valve procedures. Now available in the US.

SoloPace Introduces Innovative Temporary Pacing System for Heart Valve Procedures in the US Market #United_States #San_Francisco #FDA_Clearance #medical_technology #SoloPace_FUSION

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1 week ago

Restore Robotics Expands da Vinci Xi® Robotic Instrument Line with FDA Clearances Restore Robotics has secured FDA 510(k) approvals for two more da Vinci Xi® robotic instruments, enhancing surgical efficiency and sustainability.

Restore Robotics Expands da Vinci Xi® Robotic Instrument Line with FDA Clearances #United_States #FDA_Clearance #Henderson #da_Vinci_Xi® #Restore_Robotics

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3 weeks ago

Peijia Medical Achieves Significant Milestone with FDA Clearance for DCwire® Micro Guidewire Peijia Medical celebrates the FDA 510(k) clearance of its DCwire® Micro Guidewire, marking a pivotal achievement in global medical device market expansion and innovation.

Peijia Medical Achieves Significant Milestone with FDA Clearance for DCwire® Micro Guidewire #China #Suzhou #FDA_Clearance #Peijia_Medical #DCwire_Micro

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3 weeks ago

Endo Tools Therapeutics Announces FDA Clearance for Endomina EZFuse System Endo Tools Therapeutics has received FDA 510(k) clearance for its next-generation endomina® EZFuse system, enhancing endoscopic procedures.

Endo Tools Therapeutics Announces FDA Clearance for Endomina EZFuse System #USA #FDA_Clearance #Gosselies #Endo_Tools #EZFuse_system

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1 month ago

Ultrasound AI Achieves FDA Clearance for Groundbreaking Delivery Date Prediction Technology Ultrasound AI has received FDA De Novo clearance for its innovative Delivery Date AI technology, enhancing prenatal care with accurate delivery predictions from ultrasound images.

Ultrasound AI Achieves FDA Clearance for Groundbreaking Delivery Date Prediction Technology #United_States #Denver #FDA_Clearance #Ultrasound_AI #Delivery_Date_AI

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2 months ago

Vesalio Marks Significant Milestone with New CE Marked Neurovascular Devices and FDA Clearances Vesalio is shaking up the neurovascular landscape with the launch of new CE-marked devices and receiving FDA clearance for aspiration catheters, marking major advancements in treatment options for patients.

Vesalio Marks Significant Milestone with New CE Marked Neurovascular Devices and FDA Clearances #None #Plano #FDA_Clearance #Vesalio #NeVa_VS

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2 months ago

Advancements in Spine Surgery: Universal Clearance for Bezier Curve Rod System The Spinal Resources, Inc.'s Bezier Parametric Curve Spinal Rod System has achieved groundbreaking FDA clearance, enabling broader access for surgeons and patients.

Advancements in Spine Surgery: Universal Clearance for Bezier Curve Rod System #USA #Fort_Lauderdale #FDA_Clearance #Spinal_Resources #Bezier_Rod

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2 months ago

Bridge to Life™ Achieves Historical Approval for Advanced Organ Preservation Technology Bridge to Life™ Ltd. celebrates a significant FDA De Novo clearance for its VitaSmart™ System, transforming liver transplant preservation with innovative technology.

Bridge to Life™ Achieves Historical Approval for Advanced Organ Preservation Technology #United_States #Duluth #FDA_Clearance #VitaSmart™ #organ_preservation

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2 months ago

iotaMotion's iotaSOFT® Receives FDA Clearance for Pediatric Cohlear Implant Surgeries iotaMotion has gained FDA approval to use its iotaSOFT® robotic-assisted cochlear implant system in children aged four and older, broadening access.

iotaMotion's iotaSOFT® Receives FDA Clearance for Pediatric Cohlear Implant Surgeries #FDA_Clearance #iotaMotion #iotaSOFT®

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2 months ago

YorLabs Achieves Milestone with FDA-Cleared Imaging Device in Cardiology Procedures YorLabs, Inc. has successfully performed the first clinical procedure using its FDA-approved Zero-CapEx Intracardiac Imaging System, marking a significant advancement in cardiac imaging technology.

YorLabs Achieves Milestone with FDA-Cleared Imaging Device in Cardiology Procedures #United_States #FDA_Clearance #Beaverton #YorLabs #Intracardiac_Imaging

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3 months ago

StimLabs Secures FDA Clearance for Revolutionary Theracor™ Device from Umbilical Cord Tissues StimLabs has achieved FDA 510(k) clearance for Theracor, the first umbilical cord-derived medical device sheet, enhancing wound care options.

StimLabs Secures FDA Clearance for Revolutionary Theracor™ Device from Umbilical Cord Tissues #USA #FDA_Clearance #StimLabs #Roswell #Theracor

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3 months ago

RIVANNA's Accuro 3S Needle Guide Kit Receives FDA Clearance for Enhanced Patient Safety RIVANNA announces FDA approval for Accuro 3S Needle Guide Kit, advancing ultrasound-guided needle placement safety and efficiency.

RIVANNA's Accuro 3S Needle Guide Kit Receives FDA Clearance for Enhanced Patient Safety #United_States #FDA_Clearance #Charlottesville #RIVANNA #Accuro_3S

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3 months ago

Medivis Achieves Historic FDA Clearance for AR Navigation in Neurosurgery Medivis Inc. becomes the first company to secure FDA clearance for augmented reality navigation in neurosurgery, enhancing surgical precision.

Medivis Achieves Historic FDA Clearance for AR Navigation in Neurosurgery #USA #New_York #Augmented_Reality #FDA_Clearance #Medivis

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4 months ago

Bendit Technologies Unveils FDA-Cleared Bendit17™ Microcatheter for Enhanced Vascular Procedures Bendit Technologies has received FDA clearance for its Bendit17™ microcatheter, advancing neurovascular and endovascular care with enhanced precision and control.

Bendit Technologies Unveils FDA-Cleared Bendit17™ Microcatheter for Enhanced Vascular Procedures #USA #Tel_Aviv #FDA_Clearance #Bendit_Technologies #Bendit17

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4 months ago

Bendit Technologies Achieves FDA Clearance for Bendit17™ Microcatheter Bendit Technologies has received FDA clearance for its Bendit17™ steerable microcatheter, enhancing precision in endovascular procedures.

Bendit Technologies Achieves FDA Clearance for Bendit17™ Microcatheter #USA #Tel_Aviv #FDA_Clearance #Bendit_Technologies #Bendit17™

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4 months ago

mlHealth 360 Achieves FDA Clearance for Revolutionary AI Triage Solution in Canada mlHealth 360 has received FDA clearance for Scaida BrainCT-ICH, Canada's first AI solution for intracranial hemorrhage triage, enhancing radiology operations.

mlHealth 360 Achieves FDA Clearance for Revolutionary AI Triage Solution in Canada #Canada #FDA_Clearance #Surrey #mlHealth_360 #Scaida_BrainCT-ICH

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4 months ago

Regenity Biosciences Achieves 63rd FDA Clearance for Neurosurgical Innovations Regenity Biosciences announces its 63rd FDA clearance, demonstrating advanced solutions in neurosurgery with innovative collagen membranes.

Regenity Biosciences Achieves 63rd FDA Clearance for Neurosurgical Innovations #United_States #FDA_Clearance #Paramus,_New_Jersey #Regenity_Biosciences #DuraMatrix_Repair

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4 months ago

Piccolo Medical Expands ECGuide Technology for Pediatric Patients with FDA Approval Piccolo Medical has gained FDA clearance to broaden the use of its ECGuide technology, enhancing vascular access for pediatric and neonatal patients.

Piccolo Medical Expands ECGuide Technology for Pediatric Patients with FDA Approval #United_States #San_Francisco #FDA_Clearance #Piccolo_Medical #ECGuide

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4 months ago

Hubly Surgical's FDA Clearance Marks a Milestone in Spinal Surgery Innovation Hubly Surgical has received FDA 510(k) clearance for its Auto-Stop Drill, expanding its use in spinal decompression surgeries, enhancing patient safety.

Hubly Surgical's FDA Clearance Marks a Milestone in Spinal Surgery Innovation #USA #FDA_Clearance #Lisle #Hubly_Surgical #Auto-Stop_Drill

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5 months ago

Kelyniam Global Reports Q3 2025 Financial Results Amidst Market Challenges Kelyniam Global, Inc. announces its Q3 2025 financial results, revealing challenges in revenue and strategic updates for future growth.

Kelyniam Global Reports Q3 2025 Financial Results Amidst Market Challenges #United_States #FDA_Clearance #Canton #cranial_implants #Kelyniam

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5 months ago

MedCAD's Innovative AccuStride Plates Achieve 510(k) FDA Clearance, Enhancing Ankle Surgery Solutions MedCAD has secured 510(k) FDA clearance for its AccuStride fixation plates, enhancing surgical options for foot and ankle procedures.

MedCAD's Innovative AccuStride Plates Achieve 510(k) FDA Clearance, Enhancing Ankle Surgery Solutions #USA #Dallas #FDA_Clearance #MedCAD #AccuStride

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5 months ago

Tosoh Bioscience Launches Innovative GR01 HbA1c Testing Analyzer with FDA Approval The new GR01 HbA1c testing analyzer from Tosoh Bioscience, recently cleared by the FDA, offers quick and accurate results, enhancing diabetes management in clinical settings.

Tosoh Bioscience Launches Innovative GR01 HbA1c Testing Analyzer with FDA Approval #USA #FDA_Clearance #Grove_City #Tosoh_Bioscience #HbA1c_Analyzer

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5 months ago

YorLabs Gets FDA Clearance for Innovative Zero-CapEx Intracardiac Imaging System YorLabs has received FDA 510(k) clearance for its groundbreaking zero-CapEx Intracardiac Imaging System, aiming to innovate heart procedures.

YorLabs Gets FDA Clearance for Innovative Zero-CapEx Intracardiac Imaging System #United_States #FDA_Clearance #Beaverton #YorLabs #Intracardiac_Imaging

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5 months ago

ManaMed Revolutionizes Postoperative Recovery with PlasmaFlow® X Clearance ManaMed has officially received FDA 510(k) clearance for its innovative PlasmaFlow® X, enhancing recovery with cutting-edge technology and design.

ManaMed Revolutionizes Postoperative Recovery with PlasmaFlow® X Clearance #United_States #FDA_Clearance #ManaMed #Denton,_Texas #PlasmaFlow

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6 months ago

Prytime Medical Sets New Standard with Groundbreaking FDA Clearance for pREBOA-PRO™ Catheter Prytime Medical Devices has achieved a historic milestone with FDA 510(k) clearance for its pREBOA-PRO™ catheter, enabling extended occlusion times and enhancing surgical capabilities.

Prytime Medical Sets New Standard with Groundbreaking FDA Clearance for pREBOA-PRO™ Catheter #United_States #FDA_Clearance #Prytime_Medical #Boerne,_Texas #pREBOA-PRO™

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6 months ago

Outlook Surgical Achieves FDA Clearance for Innovative Endoscope Technology Enhancing Surgical Efficiency Outlook Surgical's Inova 1 Towerless Endoscope System has received FDA clearance, marking a significant innovation in surgical visualization and procedure efficiency.

Outlook Surgical Achieves FDA Clearance for Innovative Endoscope Technology Enhancing Surgical Efficiency #United_States #Bloomington #FDA_Clearance #Inova_1 #Outlook_Surgical

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6 months ago

Kelyniam Global, Inc. Achieves FDA Approval for Revolutionary Fusion™ BCP-PEEK Implants Kelyniam Global, Inc. has received FDA clearance for its innovative Fusion™ BCP-PEEK implants, a milestone in cranial implant technology.

Kelyniam Global, Inc. Achieves FDA Approval for Revolutionary Fusion™ BCP-PEEK Implants #United_States #FDA_Clearance #Canton #Kelyniam_Global #Fusion_Implant

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7 months ago

Senhwa Biosciences' CX-5461 Secures FDA Approval for Cancer Trials Senhwa Biosciences announced that their investigational drug CX-5461 received FDA clearance to enter clinical trials for treating B-cell lymphoma, indicating strong market potential.

Senhwa Biosciences' CX-5461 Secures FDA Approval for Cancer Trials #Taipei #USA #FDA_Clearance #Senhwa_Biosciences #CX-5461

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7 months ago

4DMedical's CT:VQ™ Achieves FDA Clearance for Advanced Imaging Solutions 4DMedical's CT:VQ™ gains FDA approval, revolutionizing ventilation-perfusion imaging without the need for contrast, enhancing patient care.

4DMedical's CT:VQ™ Achieves FDA Clearance for Advanced Imaging Solutions #USA #Los_Angeles #FDA_Clearance #4DMedical #CT:VQ™