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Category: FDA

FDA Clears CapsoVision’s Capsule Endoscopy System for Pediatric Use
Pacira BioSciences Secures FDA 510(k) Clearance for iovera° Smart Tip...
AccurKardia’s AK+ Guard Receives FDA Breakthrough Designation for Hyperkalemia Detection
Alleviant Medical Secures FDA Approval for Pivotal Heart Failure Trial
Nuclein Achieves FDA Clearance and CLIA Waiver for DASH® Rapid...
Movano’s EvieMED Ring Gains FDA Clearance for Pulse Oximeter
FDA Clears Omron’s AI-Powered Blood Pressure Monitor with AFib Detection
FDA Clears Smith+Nephew’s Stemless Anatomical Shoulder Implant
Onward Secures FDA Clearance for Non-Invasive Spinal Cord Stimulator
Roivios Secures FDA IDE for Renal Assist Device Trial
FDA Clears CapsoVision’s Capsule Endoscopy System for Pediatric Use
FDA Clears CapsoVision’s Capsule Endoscopy System for Pediatric Use
CapsoCam Plus expands access to non-invasive diagnostics for children aged 2 and above. Innovative Diagnostics for Young PatientsCapsoVision announced FDA clearance for its CapsoCam Plus system, allowing use in pediatric patients as young as...
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Pacira BioSciences Secures FDA 510(k) Clearance for iovera° Smart Tip for Chronic Low Back Pain
AccurKardia’s AK+ Guard Receives FDA Breakthrough Designation for Hyperkalemia Detection
Alleviant Medical Secures FDA Approval for Pivotal Heart Failure Trial
Nuclein Achieves FDA Clearance and CLIA Waiver for DASH® Rapid PCR System
Movano’s EvieMED Ring Gains FDA Clearance for Pulse Oximeter
FDA Clears Omron’s AI-Powered Blood Pressure Monitor with AFib Detection
FDA Clears Smith+Nephew’s Stemless Anatomical Shoulder Implant
Onward Secures FDA Clearance for Non-Invasive Spinal Cord Stimulator
Roivios Secures FDA IDE for Renal Assist Device Trial

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FDA Clears CapsoVision’s Capsule Endoscopy System for Pediatric Use
FDA Clears CapsoVision’s Capsule Endoscopy System for Pediatric Use
CapsoCam Plus expands access to non-invasive diagnostics for children...
Pacira BioSciences Secures FDA 510(k) Clearance for iovera° Smart Tip for Chronic Low Back Pain
Pacira BioSciences Secures FDA 510(k) Clearance for iovera° Smart Tip...
New device targets medial branch nerves with cryoneurolysis, offering...
AccurKardia’s AK+ Guard Receives FDA Breakthrough Designation for Hyperkalemia Detection
AccurKardia’s AK+ Guard Receives FDA Breakthrough Designation for Hyperkalemia Detection
Innovative ECG-Based AI Technology to Transform Home Monitoring for...
Alleviant Medical Secures FDA Approval for Pivotal Heart Failure Trial
Alleviant Medical Secures FDA Approval for Pivotal Heart Failure Trial
Breakthrough Designation Expands to Both HFrEF and HFpEF Populations...
Nuclein Achieves FDA Clearance and CLIA Waiver for DASH® Rapid PCR System
Nuclein Achieves FDA Clearance and CLIA Waiver for DASH® Rapid...
Game-Changing Rapid PCR Testing for COVID-19 and Flu Nuclein...
Movano’s EvieMED Ring Gains FDA Clearance for Pulse Oximeter
Movano’s EvieMED Ring Gains FDA Clearance for Pulse Oximeter
Innovative wearable transitions to clinical applications, enhancing health monitoring...
FDA Clears Omron’s AI-Powered Blood Pressure Monitor with AFib Detection
FDA Clears Omron’s AI-Powered Blood Pressure Monitor with AFib Detection
Revolutionary device integrates advanced AI to enable routine screening...
FDA Clears Smith+Nephew’s Stemless Anatomical Shoulder Implant
FDA Clears Smith+Nephew’s Stemless Anatomical Shoulder Implant
Smith+Nephew has received FDA clearance for the Aetos Stemless...
Onward Secures FDA Clearance for Non-Invasive Spinal Cord Stimulator
Onward Secures FDA Clearance for Non-Invasive Spinal Cord Stimulator
ARC-EX System offers new hope for individuals with chronic...
Roivios Secures FDA IDE for Renal Assist Device Trial
Roivios Secures FDA IDE for Renal Assist Device Trial
The JuxtaFlow system progresses to pivotal trials, offering hope...
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