FDA Archives

Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

April 14, 2025

SpineGuard to transfer of US SpineGuard Inc. to Omnia Medical

April 14, 2025

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

April 14, 2025

Elixir Medical launches the LithiX hertz contact IVL system in Europe

April 11, 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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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

OSSTEC landed £2.5m to develop 3D-printed partial knee implants

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

Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

HighLife’s TMVR solution earns FDA Breakthrough nod

FDA clears CardioVia’s ViaOne minimally invasive epicardial access system

ICU Medical wins FDA clearance for its new Infusion Devices

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

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Biocomposites’ investee Renovos Biologics receives FDA Breakthrough Device Designation for its...

Enspectra’s VIO System secures FDA 510(k) clearance

EndoSound secures FDA 510(k) approval for EndoSound Vision System

Belkin Vision’s glaucoma laser receives 510(k) clearance from FDA

ZimVie’s spinal fixation system secures FDA clearance with Brainlab’s platform

NeuroOne secures FDA clearance for OneRF ablation system

BD receives clearance for new blood collection device

Exactech wins clearance for new ankle surgery navigation system

AWAK obtains breakthrough device designation for KDPP tool

Supira receives FDA breakthrough device designation for ventricular assist device

Innoblative wins FDA IDE for electrosurgical device for breast cancer treatment

SpineGuard to transfer of US SpineGuard Inc. to Omnia Medical

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

Elixir Medical launches the LithiX hertz contact IVL system in Europe

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