FDA and CMS each play a critical role in getting new medical devices to patients, and they work most effectively when aligned ...

As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are ...

Stryker signs definitive agreement to acquire Amplitude Vascular Systems to add next-generation IVL technology to peripheral ...

Traditionally, contract negotiation has been viewed as a financial or legal responsibility, typically led by finance teams, ...

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 ...

Companies and researchers often fail to disclose negative trial results, resulting in significant gaps in the public record ...

Human factors engineering plays a critical role in the design of AI-enabled medical devices and whether they might improve care or introduce new risks.

Device Makers are currently at an intersection of accelerated innovation and heightened regulatory scrutiny. Regulatory affairs stands in the center guiding operational resilience and a coherent ...

Geography is effectively determining whether patients receive timely cardiac diagnosis, or even any diagnosis at all. In an effort to address the problem, cardiologists and health systems are ...

The MedTech industry has seen significant growth and raised expectations as it adapts to evolving healthcare needs in the wake of the COVID-19 pandemic. The industry’s ability to make technology a ...

The deeper insights provided by a single source of truth help regulatory teams pinpoint and address gaps in data collection during each trial phase. By mitigating potential risks earlier in the ...