Medical Care Technologies (OTC Pink:MDCE) Outlines Regulatory Roadmap: Dividing AI Health Platform Into Clinical and Consumer Divisions

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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?

MDCE announced splitting its AI platform into a Clinical AI Division for FDA-eligible modules and a Consumer AI Division for wellness apps.

Which MDCE AI modules are targeted for FDA pathways like 510(k) or De Novo?

MDCE named dermatological screening, ocular/retinal health analytics, and wound monitoring as FDA-eligible module targets.

Will MDCE's consumer apps be used for medical diagnosis (MDCE)?

No. The Consumer AI Division is for general wellness and research and is not intended for clinical diagnosis or treatment.

What regulatory steps did MDCE say it will pursue for clinical modules?

MDCE plans formal validation studies, clinical data collection, and regulatory pre-submission work toward 510(k) or De Novo pathways.

How might MDCE's split affect investors in MDCE in the near term?

The split clarifies regulatory focus and product positioning, but there are no completed validations or approvals yet to change near-term fundamentals.

When will MDCE begin clinical validation and regulatory submissions for its modules?

MDCE indicated validation studies and pre-submission activities are planned in upcoming quarters but gave no specific dates.