Clearance – Talk Bio

EDAP Receives FDA 510(k) Clearance for Advanced Focal One Robotic HIFU System Enhancements

4 days ago talkbio0Tagged algorithm, Clearance, Edap, Malignant neoplasm of prostate, Medical Devices, robotic HIFU, United States Food and Drug Administration

EDAP; FDA 510(k) clearance; Focal One; robotic HIFU; high intensity focused ultrasound; ultrasound imaging; prostate cancer treatment; AI algorithms; medical devices

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

1 week ago talkbio0Tagged ARC-EX System, CE Mark, Clearance, hand sensation, Hand Strength, Home Use, Medical Devices, Medical service, neurotechnology, ONWARD, Spinal Cord Injuries, United States Food and Drug Administration

ONWARD Medical; FDA 510(k) clearance; ARC-EX System; home use; spinal cord injury; hand strength; hand sensation; neurotechnology; CE Mark; medical device

Zimmer Biomet Receives U.S. FDA Clearance for Enhanced ROSA Knee Robotic Technology

1 week ago talkbio0Tagged Clearance, OptimiZe technology, Personalized, robotic knee replacement, ROSA Knee, surgical planning, United States Food and Drug Administration, Zimmer Biomet

Zimmer Biomet; FDA clearance; ROSA Knee; OptimiZe technology; robotic knee replacement; personalized surgical planning

ViTAA Medical Secures FDA 510(k) Clearance for AiORTA Plan, Launching Its Hyper-Precise Aortic Care Platform

2 weeks ago talkbio0Tagged AiORTA, Anatomical segmentation, Aortic Aneurysm, automated aortic surgery, Clearance, Clinical, cloud-based healthcare, hyper-precise aortic care, Infantile Neuroaxonal Dystrophy, measurement automation, Medical service, Preoperative, United States Food and Drug Administration, vascular AI, ViTAA, workflow improvement

ViTAA Medical; FDA 510(k) clearance; AiORTA Plan; hyper-precise aortic care; automated aortic surgery planning; vascular AI; preoperative measurement automation; cloud-based healthcare; aortic aneurysm segmentation; clinical workflow improvement

Sirona Medical Receives FDA 510(k) Clearance for Advanced Imaging Suite, Expanding PET-CT and Class II Medical Device Functionality

4 weeks ago talkbio0Tagged Advanced Imaging Suite, capabilities, Class II Medical Device, Clearance, image management, PET/CT scan, radiological imaging, regulatory approval, Sirona Medical, United States Food and Drug Administration

Sirona Medical; FDA 510(k) clearance; Advanced Imaging Suite; Radiological imaging; PET-CT capabilities; Class II medical device; image management; regulatory approval

Tempest Seeks Strategic Partners to Launch Phase 3 Liver Cancer Trial Amid Funding Challenges

8 months ago talkbio0Tagged altretamine/cisplatin/cyclophosphamide protocol, amezalpat, Avastin, biotech, Clearance, Clinical Oncology, Liver and Intrahepatic Biliary Tract Carcinoma, partnerships, Peroxisome Proliferator-Activated Receptors, Phase 3 trial, strategic, Tecentriq, United States Food and Drug Administration

Tempest Therapeutics , Amezalpat , Phase 3 Trial , Liver Cancer (HCC) , Strategic Partnerships , Biotech Funding , PPAR⍺ Antagonist , Clinical Oncology , FDA Clearance , Tecentriq and Avastin Combination Therapy