FDA 批准的基于人工智能的算法

supercell 6月 15, 2021 1.6w 浏览 0

设备或算法的名称	母公司名称	简短介绍	FDA批准号	FDA 批准类型	在公告中提及人工智能	如果 FDA 公告中没有提及 AI	日期	医学专业	二级医学专业
Arterys Cardio DL	Arterys Inc	software analyzing cardiovascular images from MR	K163253	510(k) premarket notification	deep learning		2016 11	Radiology	Cardiology
EnsoSleep	EnsoData, Inc	diagnosis of sleep disorders	K162627	510(k) premarket notification	automated algorithm		2017 03	Neurology
Arterys Oncology DL	Arterys Inc	medical diagnostic application	K173542	510(k) premarket notification	deep learning		2017 11	Radiology	Oncology
Idx	IDx LLC	detection of diabetic retinopathy	DEN180001	de novo pathway	A.I.		2018 01	Ophthalmology
Koios DS for Breast	Koios Medical, Inc	diagnostic software for lesions suspicious for cancer	K190442	510(k) premarket notification	machine learning		2019 06
ContaCT	Viz.AI	stroke detection on CT	DEN170073	de novo pathway	A.I.		2018 02	Radiology	Neurology
OsteoDetect	Imagen Technologies, Inc.	X-ray wrist fracture diagnosis	DEN180005	de novo pathway	deep learning		2018 02	Radiology	Emergency medicine
Guardian Connect System	Medtronic	predicting blood glucose changes	P160007	PMA	A.I.		2018 03	Endocrinology
EchoMD Automated Ejection Fraction Software	Bay Labs, Inc.	echocardiogram analysis	K173780	510(k) premarket notification	machine learning		2018 05	Radiology	Cardiology
DreaMed	DreaMed Diabetes, Ltd	managing Type 1 diabetes.	DEN170043	de novo pathway	A.I.		2018 06	Endocrinology
LungQ	Thirona Corporation	Quantitative analysis of chest CT scans	K173821	PMA	Not available	https://bit.ly/2EkHTCM	2018 06	Radiology	Pulmonology
BriefCase	Aidoc Medical, Ltd.	triage and diagnosis of time sensitive patients	K180647	510(k) premarket notification	deep learning		2018 07	Radiology	Emergency medicine
ProFound™ AI Software V2.1	iCAD, Inc	breast density via mammogprahy	K191994	510(k) premarket notification	deep learning		2018 07	Radiology	Oncology
SubtlePET	Subtle Medical, Inc	radiology image processing software	K182336	510(k) premarket notification	deep neural network-based algorithm		2018 09	Radiology
Arterys MICA	Arterys Inc	Liver and lung cancer diagnosis on CT and MRI	K182034	510(k) premarket notification	A.I.		2018 08	Radiology	Oncology
AI-ECG Platform	Shenzhen Carewell Electronics., Ltd	ECG analysis support	K180432	510(k) premarket notification	AI-ECG		2018 09	Cardiology
Accipiolx	MaxQ-Al Ltd	acute intracranial hemorrhage triage algorithm	K182177	510(k) premarket notification	artificial intelligence algorithm		2018 10	Radiology	Neurology
icobrain	icometrix NV	MRI brain interpretation	K181939	510(k) premarket notification	machine learning and deep learning		2018 10	Radiology	Neurology
FerriSmart Analysis System	Resonance Health Analysis Service Pty Ltd	measure liver iron concentration	K182218	510(k) premarket notification	artificial intelligence		2018 11	Internal Medicine
cmTriage	CureMetrix, Inc.	Mammogram workflow	K183285	510(k) premarket notification	artificial intelligence algorithm		2019 03	Radiology	Oncology
Deep Learning Image Reconstruction	GE Medical Systems, LLC.	CT image reconstruction	K183202	510(k) premarket notification	deep learning		2019 04	Radiology
HealthPNX	Zebra Medical Vision Ltd.	Chest X-Ray assessment pneumothorax	K190362	510(k) premarket notification	artificial intelligence		2019 05	Radiology	Emergency medicine
Advanced Intelligent Clear-IQ Engine (AiCE)	Canon Medical Systems Corporation	Noise reduction algorithm	K183046	510(k) premarket notification	Deep Convolutional Neural Network		2019 06	Radiology
SubtleMR	Subtle Medical, Inc	radiology image processing software	K191688	510(k) premarket notification	convulutional neural network		2019 07	Radiology
AI-Rad Companion (Pulmonary)	Siemens Medical Solutions USA, Inc.	CT image reconstruction – pulmonary	K183271	510(k) premarket notification	deep learning		2019 07	Radiology
Critical Care Suite	GE Medical Systems, LLC.	Chest X-Ray assessment pneumothorax	K183182	510(k) premarket notification	artificial intelligence algorithms		2019 08	Radiology	Emergency medicine
AI-Rad Companion (Cardiovascular)	Siemens Medical Solutions USA, Inc.	CT image reconstruction – cardiovascular	K183268	510(k) premarket notification	deep learning		2019 09	Radiology
EchoGo Core	Ultromics Ltd.	quantification and reporting of results of cardiovascular function	K191171	510(k) premarket notification	machine learning-based algorithms		2019 11	Cardiology	Radiology
TransparaTM	Screenpoint Medical B.V.	Mammogram workflow	K192287	510(k) premarket notification	machine learning components		2019 12	Radiology	Oncology
QuantX	Quantitative Insights, Inc	Radiological software for lesions suspicious for cancer	DEN170022	de novo pathway	artificial intelligence algorithm		2020 01	Radiology	Oncology
Eko Analysis Software	Eko Devices Inc.	Cardiac Monitor	K192004	510(k) premarket notification	artificial neural network		2020 01	Cardiology
BodyGuardian Remote Monitoring System	Preventice	Remote monitoring device for patients with cardiac arrhythmias	K121197	510(k) premarket notification	Not available	https://bit.ly/3czSSF2	2012 08	Cardiology
Temporal Comparison	Riverain Technologies	Chest X-Ray Scanning Software	K123526	510(k) premarket notification	Not available	https://wb.md/2ww0IiD	2012 12	Radiology
Ahead 100	BrainScope	Device to interprete the structural condition of the patient’s brain after head injury.	DEN140025	de novo pathway	Not available	https://bit.ly/2TqDweq	2014 08	Neurology
AliveCor	AliveCor	detection of atrial fibrillation	K140933	510(k) premarket notification	Not available	https://bit.ly/3323d8n	2014 08	Cardiology
QbCheck	QbTech AB	diagnosis and treatment of ADHD	K143468	510(k) premarket notification	Not available	https://bit.ly/39wKdBl	2016 03	Psychiatry
Steth IO	Stratoscientific, Inc.	acoustic device to collect heart and lung sounds	K160016	510(k) premarket notification	Not available	https://stethio.com/ai/	2016 07	General medicine
Cantab Mobile	CAMBRIDGE COGNITION LTD.	memory assessment for the elderly	K161328	510(k) premarket notification	Not available	https://bit.ly/39uIYm7	2017 01	Neurology	Geriatrics
AmCAD-US	AmCad BioMed Corporation	analysis of thyroid nodules	K162574	510(k) premarket notification	Not available	https://bloom.bg/38pWbeR	2017 05	Radiology	Endocrinology
Rooti Rx System ECG Event Recorder, Rooti Link APP Software	Rooti Labs Ltd	wearable continuous ECG monitor	K163694	510(k) premarket notification	Not available	https://bit.ly/3cuSdEO	2017 11	Cardiology
BioFlux	Biotricity Inc.	detecting arrhythmias	K172311	510(k) premarket notification	Not available	https://bit.ly/2VX36t4	2017 12	Cardiology
WAVE Clinical Platform	Excel Medical Electronics, LLC	Monitoring vital signs	K171056	510(k) premarket notification	Not available	https://bit.ly/2Iqfz0C	2018 01	Hospital monitoring
DM-Density	Densitas, Inc.	Breast density via mammogprahy	K170540	510(k) premarket notification	Not available	https://bit.ly/3azmgJU	2018 02	Radiology
NeuralBot	Neural Analytics, Inc.	transcranial Doppler probe positioning	K180455	510(k) premarket notification	Not available	https://bit.ly/2ItFape	2018 04	Radiology
HealthCCS	Zebra Medical Vision Ltd.	coronary artery calcification algorithm	K172983	510(k) premarket notification	Not available	https://bit.ly/2uYRSJE	2018 05	Radiology	Cardiology
MindMotion GO	MindMaze SA	software with rehabilitation exercises for the elderly	K173931	510(k) premarket notification	Not available	https://bit.ly/2wDsvxi	2018 05	Orthopedics
ECG App	Apple, Inc.	detection of atrial fibrillation	DEN180044	de novo pathway	Not available	https://bit.ly/3cB7eFd	2018 08	Cardiology
FibriCheck	Qompium NV	Cardiac Monitor	K173872	510(k) premarket notification	Not available	https://bit.ly/2VOzZIr	2018 09	Cardiology
Irregular Rhythm Notification Feature	Apple Inc.	detection of atrial fibrillation	DEN180042	de novo pathway	Not available	https://bit.ly/2TqDMdo	2018 09	Cardiology
RightEye Vision System	RightEye, LLC	identifying visual tracking impairment	K181771	510(k) premarket notification	Not available	https://bit.ly/32XTIXC	2018 09	Ophthalmology
FluoroShield™	Omega Medical Imaging, LLC	Radiation dosage reduction	K191713	510(k) premarket notification	Not available	https://bit.ly/2Tsb23W	2018 10	Radiology
Embrace	Empatica Srl	wearable for seizure monitoring	K181861	510(k) premarket notification	Not available	https://bit.ly/3aCnC6n	2018 11	Neurology
iSchemaView RAPID	iSchemaView, Inc.	stroke detection on CT and MRI	K182130	510(k) premarket notification	Not available	https://bwnews.pr/32Xl1l4	2018 12	Radiology
Quantib ND	Quantib BV	Neurodegenerative disease MRI brain reading	K182564	510(k) premarket notification	Not available	https://bwnews.pr/2TI4LQP	2018 12	Radiology
Study Watch	Verily Life Sciences LLC	ECG feature of the Study Watch	K182456	510(k) premarket notification	Not available	https://bit.ly/38oRFgw	2019 01	Cardiology
KardiaAI	AliveCor, Inc	six-lead smartphone ECG	K181823	510(k) premarket notification	Not available	https://bit.ly/2vMd5a1	2019 03	Cardiology
Loop System	Spry Health, Inc.	Monitoring vital signs	K181352	510(k) premarket notification	Not available	https://bit.ly/2xgTzD8	2019 03	Hospital monitoring
RhythmAnalytics	Biofourmis Singapore Pte. Ltd	Monitoring cardiac arrhythmias	K182344	510(k) premarket notification	Not available	https://bit.ly/32TABhC	2019 03	Cardiology
eMurmer ID	CSD Labs GmbH	Heart murmur detection	K181988	510(k) premarket notification	Not available	https://bit.ly/2TI4zkz	2019 04	Cardiology
ReSET-O	Pear Therapeutics, Inc.	adjuvant treatment of substance abuse disorder	K173681	510(k) premarket notification	Not available	https://bit.ly/3cC0zKT	2019 5	Psychiatry
ACR \| LAB Urine Analysis Test System	Healthy.io Ltd	Urinary tract infection diagnosis	K182384	510(k) premarket notification	Not available	https://bit.ly/3axoyJj	2019 07	Urology / General practise
Current Wearable Health Monitoring System	Current Health Ltd.	Monitoring vital signs	K191272	510(k) premarket notification	Not available	https://bit.ly/2VQDHBi	2019 07	Hospital monitoring
physIQ Heart Rhythm and Respiratory Module	physIQ, Inc	detection of atrial fibrillation	K183322	510(k) premarket notification	Not available	https://bit.ly/2TtjiAP	2019 07	Cardiology
RayCare 2.3	RaySearch Laboratories AB	Medical charged-particle radiation therapy system	K191384	510(k) premarket notification	Not available	https://bit.ly/2vB0yXb	2019 07	Radiology
Biovitals Analytics Engine	Biofourmis Singapore Pte. Ltd	Cardiac Monitor	K183282	510(k) premarket notification	Not available	https://bit.ly/2IrQbHW	2019 08	Cardiology
Caption Guidance	Caption Health, Inc.	Software to assist medical professionals in the acquisition of cardiac ultrasound images.	DEN190040	de novo pathway	artificial intelligence		2019 08	Radiology
BrainScope TBI	BrainScope Company, Inc	EEG-based Concussion Index	K190815	510(k) premarket notification	Not available	https://bit.ly/3azmYGZ	2019 09	Neurology
AIMI-Triage CXR PTX	RADLogics, Inc.	Chest X-ray prioritization service	K193300	510(k) premarket notification	artificial intelligence		2020 03	Radiology
EyeArt	Eyenuk, Inc	Automated detection of diabetic retinopathy	K200667	510(k) premarket notification	artificial intelligence		2020 06	Ophthalmology
qER	Qure.ai Technologies	Computer aided triage and notification software for CT images	K200921	510(k) premarket notification	artificial intelligence		2020 06	Radiology	Emergency Medicine
AVA (Augmented Vascular Analysis)	See-Mode Technologies Pte. Ltd.	Analysis and reporting of vascular ultrasound scans	K201369	510(k) premarket notification	artificial intelligence		2020 08	Radiology
Genius AI Detection	Hologic, Inc.	Software device intended to identify potential abnormalities in breast tomosynthesis images	K201019	510(k) premarket notification	machine learning		2020 11	Radiology
PixelShine	AlgoMedica	Algorithm used to de-noise CT datasets to increase image quality at reduced dose levels	K161625	510(k) premarket notification	Not available	https://bit.ly/3fv0YTo	2016 06	Radiology
Pathwork Tissue of Origin Test Kit-FFPE	Pathwork Diagnostics, Inc.	ML test to aid diagnosis of difficult-to-diagnose tumors using formalin-fixed, paraffin-embedded samples	K092967	510(k) premarket notification	machine learning		2010 06	Pathology	Oncology

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FDA 批准的基于人工智能的算法

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