Regulatory Approval Archives | Page 2 of 55 | Medical Device News by Guided Solutions

HistoSonics receives CE mark for Edison histotripsy system for liver tumors

July 14, 2026

Claria Medical earns FDA nod for integrated hysterectomy tissue extraction system

July 14, 2026

Zeta Surgical receives FDA clearance for robotic TMS stereotactic system

July 13, 2026

Spiro Robotics earns FDA clearance for image-guided system for tracheal intubation

July 13, 2026

Featured

Guided Solutions Celebrates 25 Years of Transforming Executive Search in MedTech

April 24, 2025

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

Newsletter

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HistoSonics receives CE mark for Edison histotripsy system for liver tumors

Claria Medical earns FDA nod for integrated hysterectomy tissue extraction system

Zeta Surgical receives FDA clearance for robotic TMS stereotactic system

Spiro Robotics earns FDA clearance for image-guided system for tracheal intubation

Nyra Medical enrolls first patient in mitral valve repair early feasibility study

AtaCor enrolls first patient in EV-ICD pivotal study with Abbott

First patient enrolled in study of Reflow Medical’s Spur system

Francis Medical announces publication of VAPOR 2 pivotal trial results

Neo Medical launches access platform for minimally invasive spine surgery

Cardiawave reports first Valvosoft treatments in Europe

Xtant Medical launches Trivium Shaped allograft for surgeries

Neuvotion to launch neurostim for post-stroke recovery

Stereotaxis completes $45M Robocath acquisition to strengthen robotic endovascular platform

Boustead acquires majority stake in urology robotics company UroMedTech

Vivani to sell neurotech subsidiary Cortigent to ClearOne

Zimmer Biomet to pay up to $140M for Iovera nerve therapy tech from Pacira BioSciences

CurifyLabs raises $14M Series A to expand personalized medicine platform

Leo Cancer Care raises $65M Series D to scale upright cancer care platform

NeuroBell secures €5m in new funding for US launch

Wearable neurotech company NeuroLife launches with $2.9M to restore movement after stroke

Tag: Regulatory Approval

LEM Surgical wins new FDA clearance for humanoid surgical robot

FiberSense to bring new CGM to European market with CE mark

SurGenTec gets FDA nod for lumbar facet fixation system

UNEEG Medical announces FDA 510(k) clearance for UNEEG EpiSight System

Medtronic secures CE mark for Stealth AXiS system for ENT surgery

Karl Storz gets FDA nod for exoscope for open surgery

Xenix Medical announces FDA clearance and full commercial launch of the...

Anteris to expand global heart valve trial

Reach Surgical receives CE Mark approval for SOUND REACH Swift

Genesee BioMedical receives FDA 510(k) clearance for ATLAAS device

HistoSonics receives CE mark for Edison histotripsy system for liver tumors

Claria Medical earns FDA nod for integrated hysterectomy tissue extraction system

Zeta Surgical receives FDA clearance for robotic TMS stereotactic system

Spiro Robotics earns FDA clearance for image-guided system for tracheal intubation

Guided Solutions Celebrates 25 Years of Transforming Executive Search in MedTech

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