Aletia Index — Assessment Listings

Showing 76 of 5,119 indexed · Browse all 5,119 →· 36 in pipeline

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Tool	Description	Regulatory Status	Risk	Last sync
Medtronic, Inc. ALT-001034 FDA	LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System	510k	—	Mar 2026	View
Epitel, Inc. ALT-001060 FDA	REMI AI Discrete Detection Module	510k	—	Mar 2026	View
Anumana, Inc. ALT-001065 FDA	Low Ejection Fraction AI-ECG Algorithm	510k	—	Mar 2026	View
Clarius Mobile Health Corp. ALT-001069 FDA	Clarius OB AI	510k	—	Mar 2026	View
Epitel, Inc. ALT-001071 FDA	REMI-AI Rapid Detection Module (REMI-AI RDM)	510k	—	Mar 2026	View
Exo Imaging ALT-001072 FDA	AI Platform 2.0 (AIP002)	510k	—	Mar 2026	View
Clarius Mobile Health Corp. ALT-001083 FDA	Clarius Prostate AI	510k	—	Mar 2026	View
Clarius Mobile Health Corp. ALT-001085 FDA	Clarius Median Nerve AI	510k	—	Mar 2026	View
Anumana, Inc. ALT-001087 FDA	ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)	510k	—	Mar 2026	View
Csd Labs ALT-001093 FDA	eMurmur Heart AI	510k	—	Mar 2026	View
Bay Labs, Inc. ALT-001183 FDA	Caption Guidance	510k	—	Mar 2026	View
Artera, Inc. ALT-001189 FDA	ArteraAI Prostate	510k	—	Mar 2026	View
Diagnoly ALT-006120 FDA	FETOLY	510k	—	Mar 2026	View
Caption Health ALT-003742 FDA	Caption Guidance	510k	—	Mar 2026	View
Beacon Biosignals, Inc. ALT-004275 FDA	SleepStageML	510k	—	Mar 2026	View
Tyto Care , Ltd. ALT-004324 FDA	Tyto Insights for Crackles Detection	510k	—	Mar 2026	View
Ge Medical Systems Israel, Functional Imaging ALT-004370 FDA	Clarify DL	510k	—	Mar 2026	View
Huntleigh Healthcare , Ltd. ALT-004371 FDA	Sonicaid Team3	510k	—	Mar 2026	View
Therapixel ALT-004385 FDA	MammoScreen BD	510k	—	Mar 2026	View
Ceribell, Inc. ALT-004388 FDA	Ceribell Seizure Detection Software	510k	—	Mar 2026	View
Beacon Biosignals, Inc. ALT-004408 FDA	Dreem 3S	510k	—	Mar 2026	View
Empatica S.R.L. ALT-004443 FDA	Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal	510k	—	Mar 2026	View
Deski ALT-004446 FDA	HeartFocus (V.1.1.1)	510k	—	Mar 2026	View
Caption Health, Inc. ALT-004457 FDA	Cardiac Guidance	510k	—	Mar 2026	View
Subtle Medical, Inc. ALT-004476 FDA	SubtleHD (1.x)	510k	—	Mar 2026	View

Showing 1–25 of 76

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Tool	Description	Regulatory Status	Risk	Last sync
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