FDA Archives

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

DESKi wins FDA clearance for HeartFocus AI heart exam software

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

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

Labcorp Announces Acquisition of Select Assets of BioReference Health’s Innovative Oncology and Related Clinical Testing Services Businesses

Tag: FDA

Axonics secures Australia’s TGA approval for F15 SNM system

Watkins-Conti scores FDA clearance for stress incontinence device

DentalMonitoring gains De Novo approval for orthodontic solution

Brainomix swings FDA clearance for its lung imaging AI software

FX Shoulder obtains FDA 510(k) clearance for glenoid baseplates

Baird Medical Receives Class III Certificate for Advanced Ceramic Thyroid Ablation...

Atraverse wins FDA nod for left-heart access device, raises $12.5M

Meditrina secures UKCA, CE Mark approvals for Aveta Hysteroscopy System

Profound Medical wins FDA clearance for AI to support prostate cancer...

Freyja wins FDA clearance for VereSee device

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

DESKi wins FDA clearance for HeartFocus AI heart exam software

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