FDA – Medwire

FDA

Navigating regulatory landscapes to bring safer, smarter healthcare solutions to life.

FDA Clears CardioVia’s ViaOne Technology for Safe Heart Access Without...

Proprio Secures Second FDA Clearance for AI Surgery Platform

FDA Clears CardioVia’s Needle-Free Epicardial Access System

FDA Announces Medtronic Surgical Device Recall Over Safety Concerns

FDA Clears CardioVia’s ViaOne Technology for Safe Heart Access Without Exposed Needle

FDA Clears CardioVia’s ViaOne Technology for Safe Heart Access Without Exposed Needle

CardioVia, an Israeli MedTech company, has received FDA clearance for its innovative ViaOne technology, designed to enable clinicians to access the heart's surface without using an exposed needle. This technology aims to improve the...

More on this topic

Proprio Secures Second FDA Clearance for AI Surgery Platform

Proprio Secures Second FDA Clearance for AI Surgery Platform

FDA Clears CardioVia’s Needle-Free Epicardial Access System

FDA Clears CardioVia’s Needle-Free Epicardial Access System

FDA Announces Medtronic Surgical Device Recall Over Safety Concerns

FDA Announces Medtronic Surgical Device Recall Over Safety Concerns

FDA Shakeup: Chief Medical Officer Ousted Amid HHS Layoffs

FDA Shakeup: Chief Medical Officer Ousted Amid HHS Layoffs

FDA Rejects Etripamil Nasal Spray for Heart Rhythm Disorders

FDA Rejects Etripamil Nasal Spray for Heart Rhythm Disorders

FDA Approves Vutrisiran for ATTR-CM Treatment

FDA Approves Vutrisiran for ATTR-CM Treatment

Vail Scientific Redesigns Sepsis Device With Minnetronix

Vail Scientific Redesigns Sepsis Device With Minnetronix

FDA Moves to Rehire Some Dismissed Employees, Including Neuralink Reviewers

FDA Moves to Rehire Some Dismissed Employees, Including Neuralink Reviewers

FDA Labels Boston Scientific Pacemaker Recall as Serious

FDA Labels Boston Scientific Pacemaker Recall as Serious

FDA Clears RapidAI’s 3D Imaging Tech for Head & Neck

FDA Clears RapidAI’s 3D Imaging Tech for Head & Neck

FDA Clears CapsoVision’s Capsule Endoscopy System for Pediatric Use

FDA Clears CapsoVision’s Capsule Endoscopy System for Pediatric Use

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...

AccurKardia’s AK+ Guard Receives FDA Breakthrough Designation for Hyperkalemia Detection

AccurKardia’s AK+ Guard Receives FDA Breakthrough Designation for Hyperkalemia Detection

Alleviant Medical Secures FDA Approval for Pivotal Heart Failure Trial

Alleviant Medical Secures FDA Approval for Pivotal Heart Failure Trial

Nuclein Achieves FDA Clearance and CLIA Waiver for DASH® Rapid PCR System

Nuclein Achieves FDA Clearance and CLIA Waiver for DASH® Rapid...

Movano’s EvieMED Ring Gains FDA Clearance for Pulse Oximeter

Movano’s EvieMED Ring Gains FDA Clearance for Pulse Oximeter

FDA Clears Omron’s AI-Powered Blood Pressure Monitor with AFib Detection

FDA Clears Omron’s AI-Powered Blood Pressure Monitor with AFib Detection

FDA Clears Smith+Nephew’s Stemless Anatomical Shoulder Implant

FDA Clears Smith+Nephew’s Stemless Anatomical Shoulder Implant

Get the MEDWIRE.AI Newsletter

Stay ahead in MedTech with industry updates, breakthroughs, and expert
insights—delivered straight to your inbox.

© 2025 MEDWIRE.AI. All rights reserved. MEDWIRE.AI is a trusted source for MedTech news and insights. Our website content and services are for informational purposes only. MEDWIRE.AI does not provide medical advice, diagnosis, or treatment.