FDA Archives

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

April 17, 2025

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

April 16, 2025

CeriBell earns FDA nod for pediatric seizure detection software

April 16, 2025

Phantom Neuro raises $19m Series A for neural interface

April 16, 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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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

Puzzle Medical Devices raises $30 million for heart pump

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

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

Okami Medical launches SENDERO MAX Delivery 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

Bruno Vision Care receives FDA approval for Deseyne Contact Lens with FusionTechnology

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

Bodyport’s noninvasive biomarker platform secures FDA 510(k) clearance

The rise of SkyWalker: FDA clears surgical robot for orthopedic procedures

Endologix Receives CE Mark Certification under EU-MDR for AFX®2 Endovascular AAA...

Glaukos Announces FDA 510(k) Clearance of iStent infinite®

Ambu Announces FDA Clearance of Fifth-Generation Single-Use Bronchoscope

AcuFocus Announces FDA Approval for the IC-8® Apthera™ Intraocular Lens, the First and...

FDA clears iRhythm’s ZEUS system for Zio Watch

MolecuLight’s Fluorescence Imaging Device Improves Healing of Diabetic Foot Ulcers

Waypoint Orthopedics seeks FDA 510(k) approval for smart bone awl

DyAnsys receives US FDA approval for First Relief neurostimulation device

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

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

CeriBell earns FDA nod for pediatric seizure detection software

Phantom Neuro raises $19m Series A for neural interface

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