MedTech News
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AngioDynamics wins FDA clearance for NanoKnife system in prostate tissue ablation
AngioDynamics today announced it received FDA 510(k) clearance for its NanoKnife system for prostate tissue ablation in patients with intermediate-risk prostate cancer.
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Lungpacer Medical wins FDA premarket approval for AeroPace neurostim system
Lungpacer Medical announced that it received FDA premarket approval for its flagship AeroPace neurostimulation system.
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Copan Diagnostics Announces FDA Clearance for Innovative Urine Collection Device
The solution offers clinical laboratories and healthcare providers a user-friendly, reliable, and cost-effective way to improve urine specimen collection, preservation, and transport.
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SyntheticMR receives FDA 510(k) clearance for SyMRI 15
LINKÖPING, Sweden, Dec. 6, 2024 /PRNewswire/ — SyntheticMR, leader in quantitative imaging software, is pleased to announce that its SyMRI 15 solution has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) on diagnostic image replacement of conventional images.
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FDA grants breakthrough nod to pulsed field ablation tech from Farapulse founder’s Field Medical
Field Medical announced today that it received FDA breakthrough device designation for its FieldForce pulsed field ablation (PFA) system.
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Europlaz launches new neonatal innovation that could save babies lives
A new medical innovation, developed in the UK by Europlaz, has the potential to help improve neonatal care and save the lives of more babies born prematurely or in distress according to the company.
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LifeSignals Receives EU MDR Certification for UbiqVue™ 2A Multiparameter System
MILPITAS, Calif., Dec. 5, 2024 /PRNewswire/ — LifeSignals, Inc. today announced that the UbiqVue 2A Multiparameter System has received EU MDR Certification, marking another significant milestone in deploying continuous wireless patient monitoring for population health management following FDA 510(k) Clearance last month.
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Field Medical’s FieldForce™ Ablation System Earns FDA TAP Pilot Acceptance and Breakthrough Device Designation for the Treatment of Ventricular Tachycardia.
First and only contact force pulsed field ablation (PFA) system engineered to revolutionize care for the hundreds of thousands at risk of death from ventricular tachycardia (VT).