Aletia Index — Assessment Listings

Showing 53 of 1,267 indexed · Browse all 1,267 →· 27 in pipeline

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Tool	Description	Regulatory Status	Risk	Last sync
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) Anumana, Inc. · ALT-001087 FDA	ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)	510k	—	Mar 2026	View
Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal Empatica S.R.L. · ALT-004443 FDA	Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal	510k	—	Mar 2026	View
FETOLY Diagnoly · ALT-006120 FDA	FETOLY	510k	—	Mar 2026	View
MuscleView 2.0 Springbok, Inc. (Dba Springbok Analytics) · ALT-006118 FDA	MuscleView 2.0	510k	—	Mar 2026	View
ArteraAI Prostate Artera, Inc. · ALT-001189 FDA	ArteraAI Prostate	De Novo	—	Mar 2026	View
syngo Dynamics (Version VA41D) Siemens Healthcare GmbH · ALT-006083 FDA	syngo Dynamics (Version VA41D)	510k	—	Mar 2026	View
BrightHeart View Classifier Brightheart · ALT-006088 FDA	BrightHeart View Classifier	510k	—	Mar 2026	View
Canvas Dx Cognoa, Inc. · ALT-006085 FDA	Canvas Dx	510k	—	Mar 2026	View
Velmeni for Dentists (V4D) Velmeni Inc. · ALT-006435 FDA	—	510k	—	Jun 2026	View
Clarify DL Ge Medical Systems Israel, Functional Imaging · ALT-004370 FDA	Clarify DL	510k	—	Mar 2026	View
SleepStageML Beacon Biosignals, Inc. · ALT-004275 FDA	SleepStageML	510k	—	Mar 2026	View
Corvair AliveCor, Inc. · ALT-006050 FDA	Corvair	510k	—	Mar 2026	View
CLEWICU System Clew Medical , Ltd. · ALT-006043 FDA	CLEWICU System	510k	—	Mar 2026	View
Axial3D Insight Axial Medical Printing Limited · ALT-006634 FDA	—	510k	—	Jun 2026	View
Dreem 3S Beacon Biosignals, Inc. · ALT-004085 FDA	Dreem 3S	510k	—	Mar 2026	View
eMurmur Heart AI Csd Labs GmbH · ALT-001044 FDA	eMurmur Heart AI	510k	—	Mar 2026	View
BoneMRI MRIguidance B.V · ALT-006836 FDA	—	510k	—	Jun 2026	View
HeartFlow Analysis HeartFlow, Inc. · ALT-006935 FDA	—	510k	—	Jun 2026	View
Caption Guidance Caption Health · ALT-006997 FDA	—	510k	—	Jun 2026	View
REMI AI Discrete Detection Module Epitel, Inc. · ALT-001060 FDA	REMI AI Discrete Detection Module	510k	—	Mar 2026	View
Low Ejection Fraction AI-ECG Algorithm Anumana, Inc. · ALT-001065 FDA	Low Ejection Fraction AI-ECG Algorithm	510k	—	Mar 2026	View
REMI-AI Rapid Detection Module (REMI-AI RDM) Epitel, Inc. · ALT-001071 FDA	REMI-AI Rapid Detection Module (REMI-AI RDM)	510k	—	Mar 2026	View
Clarius OB AI Clarius Mobile Health Corp. · ALT-001069 FDA	Clarius OB AI	510k	—	Mar 2026	View
AI Platform 2.0 (AIP002) Exo Imaging · ALT-001072 FDA	AI Platform 2.0 (AIP002)	510k	—	Mar 2026	View
Clarius Median Nerve AI Clarius Mobile Health Corp. · ALT-001085 FDA	Clarius Median Nerve AI	510k	—	Mar 2026	View

Showing 1–25 of 53

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Tool	Description	Regulatory Status	Risk	Last sync
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