AI医疗设备：2025年现状、监管与挑战

ByAdrienLaurent,CEOatIntuitionLabs•10/30/2025•50minread ExecutiveSummary ThefieldofAI-enabledmedicaldeviceshasexpandeddramaticallyinrecentyears,transformingmanyareasofhealthcarewhileraisingregulatory,technical,andethicalchallenges.Bylate2025,sensingandimagingsystemspoweredbymachinelearning(fromradiologyscannerstowearablemonitors)andintelligentclinicalsoftware(fromdiagnostictoolstodecisionsupport)arewidelyusedinpractice.TensofthousandsofAI-drivendeviceshavebeenclearedworldwide–forexample,theUS FoodandDrugAdministration(FDA)reportsontheorderof~950FDA-clearedAI/MLdevicesbymid-2024([1]pmc.ncbi.nlm.nih.gov)(withroughly100newapprovalseachyear),spanninghundredsofcompaniesandclinicalspecialties.Globalmarketanalysessimilarlyestimateamulti-billion-dollarindustry:oneanalystvaluedtheAI-enabledmedicaldevicemarketat$13.7billionin2024,projectingittoexceed$255billionby2033([2]www.grandviewresearch.com).Majorsuppliers(e.g.SiemensHealthineers,GE,Philips,Roche,Johnson&Johnson)nowofferAI-enhancedversionsoftraditionalequipment,whileinnovativestartupsandtechcompanies(e.g.AliveCor,iCAD,ZebraMedicalVision,GoogleʼsDeepMind)introducenewcapabilities. ThepromiseofAImedicaldevicesissignificant:theycanimprovediagnosticaccuracy,automatelaboriousimageanalyses,personalizemonitoring,andenableearlierdetectionandintervention.Forinstance,recenttrialshaveshownAIalgorithmsmatchingexpertperformanceininterpretingimagingstudiesandevenimprovingphysiciansʼaccuracywhenusedintandem(e.g.deep-learningsystemsinbreastcancerscreening([3]pmc.ncbi.nlm.nih.gov),retinaldiseasedetection,orcardiacarrhythmiaanalysis).SimplertoolslikeautomatedimagingtriageormobileECGscanbroadenaccesstospecialtycare.Economically,analystsproject“acceleratedadoptionofAI-driventoolsacrossdiagnostics,imaging,patientmonitoring,andtreatmentdevices”([4]www.futuremarketinsights.com). However,challengesandconcernsareequallyprominent.ResearchersnotethatthehighexpectationsforAIarenotyetmatchedbyrobustclinicalevidence:systematicreviewsfindthatonlyatinyfractionofclearedAIdevicesaresupportedbyrandomizedtrialsorpatient-outcomedata([5]pmc.ncbi.nlm.nih.gov).TherehavebeenreportsofpatientharmwhenAItoolsweremisapplied,includingdevicemalfunctionsleadingtoinjuriesorevenadeathinonereportedcase([6]pmc.ncbi.nlm.nih.gov).Expertswarnofalgorithmicbias(forexample,anICUtriagetoolthatunder-identifiedBlackpatientsforextracare([7]spectrum.ieee.org)),ofautomationbiasand“deskilling”ofclinicians(recentstudiesincolonoscopyfounddoctorsʼdetectionratesfellwhenover-reliantonAI([8]time.com)),andofprivacy/safetyissues(withmedicaldatabreachesoradversarialattacks).Moreover,regulatorsworldwidestruggletokeeppace.TheFDAandpeershaveonlyrecentlyissueddetailedAI/MLguidance(e.g.theFDAʼs2024finalizedAIguidanceamid~1,000cleareddevices([9]www.techtarget.com)),andinternationalapproachesdiffer(e.g.theEUʼsnewAI Actappliesa“high-risk”labeltomanyhealthcareAIsystems([10]www.medtecheurope.org),complicatingcompliancewithexistingmedicaldevicerules). ThisreportprovidesacomprehensiveanalysisofthecurrentstatusofAImedicaldevicesasoflate2025,coveringhistoricalcontext,technicalandclinicaldomains,regulatoryframeworks,implementationissues,andfuturedirections.Wereviewmultipleperspectives—industry,healthcareproviders,patients,regulators,andethicists—andincorporatecasestudies(e.g.AIinradiology,cardiology,ophthalmology,anddigitalhealth).Wepresentdataonmarketgrowthandadoption(includingspecializedtables),andexaminetheevidencebaseforperformanceandsafety.Finally,wediscussfuturepossibilities(fromgenerativeAIintegrationtoremotemonitoring)andtheimplicationsforhealthcaresystemsandsociety.Throughout,allclaimsaresupportedbyup-to-date,crediblesources.Keyfindingsinclude: Rapidgrowthinapprovalsandadoption:ThenumberofFDA-clearedAI/MLdevicesnearlydoubledbetween2022and2025,withAIapplicationsnowspanningradiology,cardiology,neurology,ophthalmology,andmanyotherfields([11]www.linkedin.com)([1]pmc.ncbi.nlm.nih.gov).Marketanalysesprojectcontinuedexplosivegrowth(CAGR~30–40%)([2]www.grandviewresearch.com)([4]www.futuremarketinsights.com). Regulatorymomentumandgaps:Majorregulatorshavebegunupdatingguidelines.TheFDAinlate2024issuedfinalguidanceonstreamlinedreviewforAI/MLdevices([9]www.techtarget.com),andmaintainsapublic“AI-EnabledDevice”list([12]www.fda.gov).WHOin2023publishedrecommendationsfocusingontransparency,dataquality,andlifecycleoversight(www.who.int)(www.who.int).TheEUʼsAI Act(ineffect2024)treatsmanymedicalAIsystemsas“highrisk”,addingcompliancerequirementsontopoftheEUMedicalDeviceRegulation([10]www.medtecheurope.org).TheUKandCanadahaveinitiativesaddressingAIinhealth.Nevertheless,studiesfindFDAdecisionsummariesoftenomitcriticalefficacy/safetydetails([5]pmc.ncbi.nlm.nih.gov),andglobaladherencetostandardsisuneven. Mixedclinicalevidenceandexpertviews:CliniciansrecognizeAIʼspotentialbutalsolimitations.SurveysofradiologistsshowoptimismaboutAIaidingimageinterpretation(particularlyincancerscreening),yetnearlyhalfofrespondentsdoubtedpatientswouldacceptAI-onlyresults([3]pmc.nc