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Theraclion wins a De Novo for treating varicose veins with focused ultrasound Onkos Surgical extends its antibacterial coating to more ELEOS titanium parts Siemens Healthineers names its diagnostics carve-out Olyrian and sets mid-2028 FX Shoulder clears the first stemless reverse shoulder system sold in the US Edwards raises its 2026 outlook a third time on $1.24B of TAVR sales CMS pays non-contrast imaging the same rate in hospitals and offices from 2027 Mobia Medical lifts 2026 guidance after a 73 percent revenue quarter PulseAI clears an arrhythmia model that reads single-lead ECG from wearables Baird Medical's partner files a 510(k) for an irreversible electroporation system Theraclion wins a De Novo for treating varicose veins with focused ultrasound Onkos Surgical extends its antibacterial coating to more ELEOS titanium parts Siemens Healthineers names its diagnostics carve-out Olyrian and sets mid-2028 FX Shoulder clears the first stemless reverse shoulder system sold in the US Edwards raises its 2026 outlook a third time on $1.24B of TAVR sales CMS pays non-contrast imaging the same rate in hospitals and offices from 2027 Mobia Medical lifts 2026 guidance after a 73 percent revenue quarter PulseAI clears an arrhythmia model that reads single-lead ECG from wearables Baird Medical's partner files a 510(k) for an irreversible electroporation system

The Directory / Respiratory & Sleep

Respiratory & Sleep Digital Health & SaMD

Neurotronics

Acquired · 510(k) cleared

Makes sleep diagnostic software and home sleep apnea testing products, including Polysmith, NomadAir and the Sleep Analysis Module. It operates as a Nihon Kohden company.

FDA DECISIONS ON FILE

1 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Oct 9, 26	K261521510(k)	Sleep Analysis Module	Neurotronics, LLC	Neurology	OLZ

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Neurotronics

FDA DECISIONS ON FILE

COVERAGE