Medical Care Technologies (OTC Pink:MDCE) Outlines Regulatory Roadmap: Dividing AI Health Platform Into Clinical and Consumer Divisions
Medical Care Technologies (OTC Pink: MDCE) on October 7, 2025 announced a strategic split of its AI health platform into two divisions: a Clinical AI Division targeting FDA-eligible modules and formal validation, and a Consumer AI Division for general wellness and research apps.
The Clinical Division lists dermatological screening, ocular/retinal analytics, and wound monitoring as modules intended for regulatory pathways such as FDA 510(k) or De Novo, with planned validation studies and pre-submission work in upcoming quarters. The Consumer Division will deliver non-diagnostic wellness tools like mental health trackers and lifestyle scoring for apps and research partnerships.
Medical Care Technologies (OTC Pink: MDCE) il 7 ottobre 2025 ha annunciato una divisione strategica della sua piattaforma di salute basata sull'IA in due divisioni: una Divisione AI Clinica rivolta a moduli idonei dalla FDA e a una convalida formale, e una Divisione AI per Consumatori per benessere generale e app di ricerca.
La Divisione Clinica elenca la screening dermatologico, analisi oculare/retinien e monitoraggio di ferite come moduli destinati a percorsi normativi quali FDA 510(k) o De Novo, con studi di validazione pianificati e attività di pre-sottomissione nei prossimi trimestri. La Divisione Consumer offrirà strumenti di benessere non diagnostici come tracciatori di salute mentale e punteggio di stile di vita per app e partnership di ricerca.
Medical Care Technologies (OTC Pink: MDCE) anunció el 7 de octubre de 2025 una división estratégica de su plataforma de salud con IA en dos divisiones: una División de IA Clínica orientada a módulos aptos para la FDA y validación formal, y una División de IA para Consumidores para bienestar general y apps de investigación.
La División Clínica enumera cribado dermatológico, analítica ocular/retina y monitoreo de heridas como módulos destinados a vías regulatorias como FDA 510(k) o De Novo, con estudios de validación y trabajo previo a la presentación planificados para los próximos trimestres. La División de Consumidores entregará herramientas de bienestar no diagnósticas como rastreadores de salud mental y puntuación de estilo de vida para apps y asociaciones de investigación.
Medical Care Technologies (OTC Pink: MDCE)는 2025년 10월 7일 AI 건강 플랫폼을 두 부문으로 전략적으로 분할한다고 발표했습니다: FDA 적합 모듈 및 공식 검증을 목표로 하는 임상 AI 부문과 일반 건강 및 연구 앱을 위한 소비자 AI 부문.
임상 부문은 피부 질환 스크리닝, 눈/망막 분석, 상처 모니터링을 규제 경로(FDA 510(k) 또는 De Novo) 대상으로 하는 모듈로 나열하며, 다가오는 분기 내에 검증 연구 및 사전 제출 작업을 계획하고 있습니다. 소비자 부문은 앱과 연구 파트너십을 위한 정신 건강 트래커 및 라이프스타일 점수 같은 비진단적 웰니스 도구를 제공할 예정입니다.
Medical Care Technologies (OTC Pink: MDCE) a annoncé le 7 octobre 2025 une scission stratégique de sa plateforme de santé IA en deux divisions: une Division IA Clinique visant des modules éligibles à la FDA et une validation formelle, et une Division IA Grand Public pour le bien-être général et les applications de recherche.
La Division Clinique énumère le dépistage dermatologique, l’analytique oculaire/rétinienne et la surveillance des plaies comme modules destinés à des voies réglementaires telles que FDA 510(k) ou De Novo, avec des études de validation prévues et des travaux de pré-soumission dans les prochains trimestres. La Division Consommateurs fournira des outils de bien-être non diagnostiques tels que des traqueurs de santé mentale et un score de mode de vie pour des apps et des partenariats de recherche.
Medical Care Technologies (OTC Pink: MDCE) gab am 7. Oktober 2025 die strategische Aufteilung seiner KI-Gesundheitsplattform in zwei Divisionen bekannt: eine Klinische KI Division mit Fokus auf FDA-fähige Module und formelle Validierung, und eine Konsumenten-KI Division für allgemeines Wohlbefinden und Forschungs-Apps.
Die Klinische Division listet dermatologisches Screening, Augen-/Retina-Analytik und Wundüberwachung als Module auf, die auf regulatorische Wege wie FDA 510(k) oder De Novo abzielen, mit geplanten Validierungsstudien und Vor submissions Arbeiten in den kommenden Quartalen. Die Konsumenten-Division wird nicht-diagnostische Wellness-Tools wie Mental-Health-Tracker und Lebensstil-Bewertung für Apps und Forschungskooperationen bereitstellen.
Medical Care Technologies (OTC Pink: MDCE) أعلنت في 7 أكتوبر 2025 عن تقسيم استراتيجي لمنصة الصحة المدعومة بالذكاء الاصطناعي إلى قسمين: قسم الذكاء الاصطناعي السريري الموجّه للوحدات المؤهلة من قبل هيئة الغذاء والدواء FDA والتحقق الرسمي، وقسم الذكاء الاصطناعي للمستهلكين للرفاهية العامة وتطبيقات البحث.
يحدد قسم العيادة فحص الأمراض الجلدية، التحاليل العينية/الشبكية، ومراقبة الجروح كوحدات مخصصة لمسارات تنظيمية مثل FDA 510(k) أو De Novo، مع دراسات التحقق والعمل المبكر قبل التقديم في الربع التالي. سيقدم قسم المستهلكين أدوات رفاهية غير تشخيصية مثل متتبعات الصحة العقلية وتقييم نمط الحياة للتطبيقات وشراكات البحث.
Medical Care Technologies (OTC Pink: MDCE) 于 2025 年 10 月 7 日宣布将其基于 AI 的健康平台战略性拆分为两大部门：一是面向 FDA 合格模块与正式验证的 临床 AI 部门，二是面向一般健康与研究应用的 消费者 AI 部门。
临床部门将皮肤科筛查、眼部/视网膜分析和伤口监测列为面向监管路径（如 FDA 510(k) 或 De Novo）的模块，并计划在未来季度开展验证研究和提交前工作。消费者部门将提供非诊断性的健康工具，如心理健康追踪器和生活方式评分，用于应用和研究伙伴关系。
- Clear organizational split into Clinical and Consumer divisions
- Clinical Division targets FDA 510(k)/De Novo regulatory pathways
- Named clinical modules: dermatology, ocular retinal analytics, wound monitoring
- Planned formal validation studies and regulatory pre-submissions
- No completed clinical validation or FDA clearances announced
- Consumer modules explicitly not intended for diagnosis or treatment
- Forward-looking plans subject to regulatory, data quality, and tech risks
MESA, ARIZONA / ACCESS Newswire / October 7, 2025 / Medical Care Technologies Inc. (OTC Pink:MDCE), an emerging innovator in AI-driven preventive healthcare, today announced its strategic plan to separate its artificial intelligence health applications into two distinct divisions - one designed for clinical validation and regulatory approval, and another tailored for consumer and research-based wellness monitoring.
The company's proprietary platform integrates multiple diagnostic and predictive modules powered by deep learning, computer vision, and biometric analytics. As part of its responsible development roadmap, MDCE has identified which components align with recognized medical datasets, regulatory pathways, and FDA validation potential - and which are best positioned for general wellness and behavioral research markets.
Clinical Division: FDA-Eligible Modules
MDCE's Clinical AI Division looks tol include technologies and datasets that can be recognized and supported by the medical community and can advance through regulated validation processes such as FDA 510(k) or De Novo pathways. These modules include:
Dermatological Screening:
Using established, peer-reviewed datasets, MDCE's skin lesion analysis engine will target early detection of melanoma and related conditions for integration into dermatological workflows.Ocular Imaging and Retinal Health Analytics:
Algorithms trained on established ophthalmic datasets will aim to identify early indicators of diabetic retinopathy and vascular disease - supporting FDA-eligible medical device classifications.Wound Monitoring and Healing Assessment:
The wound care module, designed for hospitals and clinics, will leverage real-time image tracking to predict infection risk and accelerate post-surgical recovery analytics.
These modules are expected to advance toward formal validation studies, clinical data collection, and regulatory pre-submission processes in upcoming quarters.
Consumer Division: Predictive Wellness and Behavioral AI
The Consumer AI Division will include emerging applications that provide general health insights and behavioral analytics but are not currently intended for medical diagnosis or treatment. These may include:
Mental Health & Micro-Expression Tracker:
Designed to assess stress and emotional patterns through facial analytics, this module will be offered in a standalone app for wellness, behavioral monitoring, and research partnerships, not for clinical use.Lifestyle & Preventive Health Scoring:
Predictive models combining skin tone, eye health, and facial metrics to offer lifestyle and wellness feedback for consumers interested in preventive care.
Forward-Looking Statements / Safe Harbor
This press release contains forward-looking statements regarding anticipated research, regulatory, and business outcomes. Such statements involve risks and uncertainties, including changes in regulatory frameworks, data quality, and technological developments. Actual results may differ materially. Medical Care Technologies Inc. assumes no obligation to update forward-looking statements except as required by law.
About Medical Care Technologies Inc.
Medical Care Technologies Inc. (OTC Pink: MDCE) is developing a next-generation AI health analytics platform that uses image-based and biometric data to predict, detect, and prevent chronic disease. Its mission is to create accessible, non-invasive screening tools that empower both clinicians and individuals to identify health risks before they become critical.
Contact:
Investor Relations Medical Care Technologies Inc.
info@infiniteauctions.com
Company Website: www.medicalcaretechnologies.com for more information.
SOURCE: Medical Care Technologies Inc. (OTC PINK:MDCE)
View the original press release on ACCESS Newswire
FAQ
What did Medical Care Technologies (MDCE) announce on October 7, 2025?
Which MDCE AI modules are targeted for FDA pathways like 510(k) or De Novo?
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What regulatory steps did MDCE say it will pursue for clinical modules?
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