AI and Wearables: On April 15, Cala Health received FDA clearance for the kIQ Plus system — a wearable device for treating Parkinson’s disease tremors featuring adaptive calibration technology Source: https://finance.yahoo.com/sectors/healthcare/articles/cala-health-lands-50m-investment-114240640.html?_guc_consent_skip=1778059789

Digital twins allow companies to test device performance in virtual simulations, with the healthcare market expected to exceed $90 billion by 2029. The sector is experiencing rapid growth, driven by AI, IoT adoption, and personalized surgical planning. Source: https://www.veloxconsultants.com/insights/digital-twin-market-growth-analysis-2024-2029#:~:text=The%20Global%20Digital%20Twin%20Market,goals%2C%20and%20enhance%20asset%20management

The Indian state of Kerala is actively positioning itself as a regional hub for medical device manufacturing and diagnostics, aiming to attract both domestic and international investment. Key focus areas: • OEM manufacturing• Diagnostics and digital health• Attraction of international medtech companies India is strengthening its role as a viable alternative to China in global […]

The European Commission is advancing a major reform of MDR and IVDR aimed at reducing regulatory burden while maintaining safety. Key proposal: abolishing the fixed 5-year certificate validity and replacing it with continuous, risk-based oversight. Clinical evidence expectations also loosen. Source: https://www.mddionline.com/medical-device-regulations/eu-moves-to-ease-mdr-ivdr-compliance-with-risk-based-changes

Dixion GmbH confirms compliance with key international standards for quality and safety of medical devices. As part of the regular three-year certification cycle, Dixion GmbH has successfully completed a comprehensive audit conducted by the independent certification body SGS. The audit covered:• MDR (Medical Device Regulation) certification audit• ISO 13485 surveillance audit• MDD surveillance audit The […]