Following recent FDA clearances, Medtronic is accelerating access to integrated planning, navigation, and robotics platform across Europe.
Validation documentation should define process parameters, monitoring strategies, and operating ranges that can support future production increases. How does a practical framework for validation, revalidation, and process control help during medical device scale-up?
Companies developing or deploying AI systems now face increasing scrutiny around risk classification, transparency and lifecycle governance. An AI management system (AIMS) aligned with ISO/IEC 42001 provides a structured way to address these challenges while significantly improving efficiency, quality, and innovation outcomes — and ensuring AI system are effective, safe, compliant, and trustworthy.
No longer a horizon technology, Artificial Intelligence in healthcare has reached a level of real-world performance that makes clinical value demonstrable at a critical time in healthcare – a time of clinician shortages, backlogs, and rising costs that have made access to treatment a challenge.
Many challenges of designing and validating pediatric digital health devices are over-looked across developmental stages. Regulatory strategy, human factors, software architecture, and algorithm performance are critical consideration in dynamic patient populations.
New pathway cuts red tape and brings predictability to Medicare coverage for Breakthrough Devices.
Having already set expectations around the structured capture of medical device safety data, regulators are now ready to analyze related insights, and they expect device manufacturers to match this capability.
Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record and a publication bias that obscures the true landscape of drug development outcomes—overrepresenting successes and underrepresenting failures. This gap can also create a distorted perception of the safety and efficacy of medical products.
New technology designed to provide a single irrigation management system for ureteroscopy, cystoscopy, percutaneous nephrolithotomy (PCNL) and benign prostatic hyperplasia (BPH) procedures.
New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas.