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Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

MintNeuro raises 4.4 million euros for chips designed into neural implants iRhythm closes the VitalConnect deal at $287.5M, mostly in cash HeartSciences clears the MyoVista ECG hardware under K260005 without its AI algorithm FDA approves an Abbott update that shows CardioMEMS patients their own pressure readings UK accepts 44 AI commission recommendations and moves to continuous device monitoring Click Therapeutics clears Motivista for the negative symptoms of schizophrenia NeuWire Medical wins an IDE for a 135-patient trial of battery-free vagus nerve stimulation GE HealthCare pays $945M cash for Sofie Biosciences and 15 PET manufacturing sites Zenflow raises $52M and hands Cook Medical US distribution for the Spring implant MintNeuro raises 4.4 million euros for chips designed into neural implants iRhythm closes the VitalConnect deal at $287.5M, mostly in cash HeartSciences clears the MyoVista ECG hardware under K260005 without its AI algorithm FDA approves an Abbott update that shows CardioMEMS patients their own pressure readings UK accepts 44 AI commission recommendations and moves to continuous device monitoring Click Therapeutics clears Motivista for the negative symptoms of schizophrenia NeuWire Medical wins an IDE for a 135-patient trial of battery-free vagus nerve stimulation GE HealthCare pays $945M cash for Sofie Biosciences and 15 PET manufacturing sites Zenflow raises $52M and hands Cook Medical US distribution for the Spring implant

The Directory / Neurology & Neurotech

Neurology & Neurotech Cardiovascular

Piraeus Medical

Maple Grove, MN · Unknown · 510(k) cleared

Makes linerless neurointerventional access catheters, including the NeuGlide and NeuFlex lines, for introducing devices into neuro, coronary and peripheral vasculature.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Sep 4, 26	K262277510(k)	70 NeuGlide Catheter	Piraeus Medical, Inc.	Cardiovascular	QJP
Aug 27, 26	K260751510(k)	35 Helix Guidewire	Piraeus Medical, Inc.	Cardiovascular	MOF

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