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

FDA outlines best practices for healthcare AI, alongside Canada, U.K. regulators

Trice Medical nabs first FDA go-ahead for disposable arthroscope with 25-degree...

Luminopia scores FDA De Novo for VR treatment for lazy eye

Kerecis Announces First-Ever Fish-Skin Implantable Medical Product for Surgery

HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

Q’Apel Medical Secures U.S. Patent for its SelectFlex™ Technology

Organon Receives FDA Clearance for Technological Updates to the Jada® System,...

SyncThink scores FDA clearance for AI system to aid concussion diagnosis

iotaMotion Announces FDA De Novo Request to Market its Robotic-Assisted Cochlear...

Labcorp Receives FDA EUA for Combo COVID-19/Flu Home Collection Kit

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