FDA Archives

Lifeward launches next-gen ReWalk 7 personal exoskeleton in the US

April 17, 2025

Cadwell invests in Seer Medical

April 17, 2025

LUMA Vision nets FDA clearance for 4D imaging catheter

April 17, 2025

RadNet to acquire breast imaging AI vendor iCAD for $103m

April 17, 2025

Featured

FDA clears NeurAxis’ self-inflating balloon device RED

January 30, 2025

Guided Solutions Appoints Marco Müller as New Managing Director Germany to Drive Strategic Growth

November 6, 2024

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

October 16, 2024

FDA clears portable blood, IV fluid warmer from Mequ

June 10, 2024

Newsletter

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Cadwell invests in Seer Medical

Phantom Neuro raises $19m Series A for neural interface

SecondWave secures $7m in funding for ultrasound device

Neuranics secures $8m for TMR magnetic sensing technology growth

Fire1 heart failure system performs well in first-in-human study

Data backs Cala neurostim for treating essential tremor

Anaconda Biomed enrolls first patient in study of funnel catheter for treating stroke

Study backs Median Technologies’ AI lung cancer screening software

Lifeward launches next-gen ReWalk 7 personal exoskeleton in the US

Elixir Medical launches the LithiX hertz contact IVL system in Europe

Surmodics launches Pounce XL thrombectomy system

Voom Medical Devices to launch single-use sterile Revcon Screw System

LUMA Vision nets FDA clearance for 4D imaging catheter

EBR Systems wins FDA nod for leadless cardiac pacing device for heart failure

CeriBell earns FDA nod for pediatric seizure detection software

DESKi wins FDA clearance for HeartFocus AI heart exam software

RadNet to acquire breast imaging AI vendor iCAD for $103m

Kandu Health and Neurolutions merge into BCI company targeting stroke care

Alcon agrees to acquire Lensar and its robotic cataract laser system

TOOsonix and Consultronix to introduce ultrasound skin therapy in Poland

Tag: FDA

FDA authorises Prenosis’ AI-based tool for sepsis diagnosis

FDA clears Affinity Biosensors’s LifeScale AST diagnostic platform

WAT Medical wins FDA nod for OTC migraine preventative device

Coreline Soft win FDA 510(k) clearance for AI-powered coronary artery calcification...

Tandem Mobi automated insulin pump wins FDA nod for expanded pediatric...

Fractyl Health receives IDE approval for Revita trial

FDA clears Eko Health’s AI for heart failure detection

Editors’ Choice: Q1 2024 in MedTech

Baird receives Class III certificate for thyroid treatment needle

Synaptive Medical wins FDA nod for near-infrared fluorescence in robotic exoscope

Lifeward launches next-gen ReWalk 7 personal exoskeleton in the US

Cadwell invests in Seer Medical

LUMA Vision nets FDA clearance for 4D imaging catheter

RadNet to acquire breast imaging AI vendor iCAD for $103m

FDA clears NeurAxis’ self-inflating balloon device RED

Guided Solutions Appoints Marco Müller as New Managing Director Germany to Drive Strategic Growth

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

FDA clears portable blood, IV fluid warmer from Mequ