A long-overdue push to reduce administrative friction, improve access to patient data, and move the system away from ...

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

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

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

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

As of October 2023, the FDA had identified 692 artificial intelligence/machine learning- enabled products that received clearance for marketing, with sustained growth projected for both submission ...

Titanium has become a vital material in modern medicine due to its strength, light weight, corrosion resistance, and exceptional biocompatibility with high long-term success rates and minimal risk of ...

The future of healthcare lies in the successful integration of workflow automation and advanced technologies. As the buzz-word salad of AI, such as NLP, LLMs, Gen AI, RPA, etc continue to evolve, ...

In February, Hologic received FDA clearance for its Genius Digital Diagnostics System, which combines advanced imaging with AI-assisted review for cervical cancer screening. We spoke with Mike Quick, ...

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 ...

Steps to ensure your medical device labels are in compliance with global regulations and have the longevity to withstand your device’s intended use. EU MDR required companies to make significant ...