MedTech

DICOM and FHIR in the Same System: Integration Patterns for Imaging-Heavy Platforms DICOM and FHIR are two healthcare standards that address different problems and increasingly need to work together in the same system: DICOM (Digital Imaging and Communications in Medicine) encodes and transmits medical images, while FHIR (Fast Healthcare Interoperability Resources) exchanges... By Alexandru Artimon Sep 7, 2026

Cloud PACS Architecture: Build, Buy, or Extend for Medical Imaging Platforms A cloud PACS is a Picture Archiving and Communication System that stores, manages, and delivers medical images from cloud infrastructure rather than on-premise servers, using the DICOM standard to encode images and DICOMweb services to move them over the web.... By Alexandru Artimon Aug 31, 2026

The EU AI Act Deadline Moved: What the 2026 Digital Omnibus Changes for Medical Device Software The Digital Omnibus on AI is a 2026 amendment to the EU AI Act that postpones the application of high-risk AI obligations, including those for AI-enabled medical device software, while leaving the AI Act’s transparency and AI literacy obligations on... By Alexandru Artimon Aug 18, 2026

MedTech Product Development: From Concept to Regulatory Clearance MedTech product development is the regulated process of designing, engineering, verifying, validating, and submitting a medical device or device software for market clearance under FDA design controls, EU MDR requirements, or both. The medical device product development lifecycle spans six... By Andrei Blaj Jun 18, 2026

MedTech Software Development: Standards, Tech Stack, and Partner Selection MedTech software development is the process of building software for medical devices, clinical platforms, and digital health systems, subject to regulatory frameworks such as IEC 62304, ISO 13485, and the FDA Software as a Medical Device (SaMD) classification. The wrong... By Andrei Blaj Jun 4, 2026

AI in MedTech: Applications, Regulatory Requirements, and Case Studies AI in MedTech is the application of machine learning and deep learning algorithms to regulated medical technology—medical imaging, drug development, surgical robotics, remote patient monitoring, electronic health records, predictive analytics, and fraud detection—operating under FDA design controls, EU MDR, and... By Andrei Blaj Apr 29, 2026