Clearance – Talk Bio

FDA Clears BrainSpace Intellidrop: Automated Neuro Device Tackling ICU Nursing Shortages and Advancing Physical AI

5 days ago talkbio0Tagged Administration occupational activities, brain fluid, BrainSpace, Clearance, ICU, ICU nursing shortages, Intellidrop, neuro injury, Physical AI, United States Food and Drug Administration

FDA clearance; BrainSpace; Intellidrop; ICU nursing shortages; brain fluid management; Physical AI; neuro injury

Medivis First to Receive FDA Clearance for Augmented Reality Navigation in Neurosurgery

3 weeks ago talkbio0Tagged AR navigation, augmented, Clearance, Cranial Navigation platform, cranial neurosurgery, External Ventricular Drain, ICU bedside procedures, intraoperative guidance, Medivis, neurosurgery innovation, Spine Navigation, surgical intelligence, United States Food and Drug Administration

Medivis; FDA 510(k) clearance; augmented reality; AR navigation; cranial neurosurgery; intraoperative guidance; cranial navigation platform; external ventricular drain; ICU bedside procedures; surgical intelligence; spine navigation; neurosurgery innovation

Insilico Medicine and TaiGen sign exclusive licensing deal for AI-designed PHD inhibitor ISM4808 to treat anemia in chronic kidney disease

4 weeks ago talkbio0Tagged AI-driven, Anemia, CDE, China, Chronic Kidney Diseases, Clearance, clinical-stage biotech, Drug Discovery, Generative AI, Indonesian language, Insilico Medicine, ISM4808, License Agreement, Oral cavity, Ph.D., Pharma, PHD inhibitor, TaiGen Biotechnology

Insilico Medicine; TaiGen Biotechnology; license agreement; ISM4808; PHD inhibitor; anemia of Chronic Kidney Disease; CKD anemia; AI-driven drug discovery; Pharma.AI; Greater China rights; oral PHD inhibitor; IND clearance; China CDE; generative AI; clinical-stage biotech

RapidAI Deepens Partnership with Amazon AWS to Expand Clinical Imaging AI Deployment

1 month ago talkbio0Tagged Alagille Syndrome, Amazon Web Services, Clearance, clinical AI, Healthcare AI, imaging AI, Lumina 3D, neurovascular AI, Rapid Edge Cloud, RapidAI, RSNA, United States Food and Drug Administration

RapidAI; Amazon Web Services; AWS; clinical AI; imaging AI; RSNA 2025; FDA clearance; Rapid Edge Cloud; healthcare AI; neurovascular AI; Lumina 3D

Kane Biotech Announces Third Quarter 2025 Financial Results

1 month ago talkbio0Tagged Clearance, distributor network, financial results, gross profit, Kane Biotech, net loss, Revenue, revyve, third quarter 2025, United States, United States Food and Drug Administration, wound care

Kane Biotech; third quarter 2025; financial results; revenue; gross profit; net loss; revyve; wound care; FDA 510(k) clearance; U.S. distributor network

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

2 months 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

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

2 months 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

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

2 months 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

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

2 months 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

2 months 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