MedTech News
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.
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.
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.
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).
Shaking sensor continuously monitors inflammation
Implantable device works like a tree branch to grab and fling proteins
Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Guidewire Handle
CLEVELAND, Dec. 4, 2024 /PRNewswire/ — Centerline Biomedical, Inc. (“Centerline”), an innovative leader in cardiovascular navigation and visualization systems, announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its new IOPS Guidewire Handle
ShiraTronics initiates FDA IDE study for implantable neuromod
ShiraTronics announced that it initiated its FDA investigational device exemption (IDE) pivotal trial for its neuromodulation therapy.
Zimmer Biomet Receives FDA Clearance for Persona® SoluTion™ PPS® Femur
WARSAW, Ind., Dec. 4, 2024 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of Persona® SoluTion™ Porous Plasma Spray (PPS®) Femur, a total knee implant component offering an alternative for patients with sensitivities to bone cement and/or metal.