Reverse engineering carries a reputation problem in medical device circles; it sounds like copying. In practice, it's a legitimate engineering discipline with specific, defensible use cases: replacing ...

A persistent tension exists between the drive for rapid technological advancement, the mandate for government oversight, and the paramount importance of patient safety. It is a foundation for the U.S.

This blog explores the transformative potential of AI assistants in healthcare management and delves into the benefits for providers, medical assistants, and obviously, patients. Imagine the daily ...

Orthogonal worked with Brian Binkowski, to gain a clearer picture of the state of SaMD approvals in the U.S. Following is what they learned about the rate of FDA approvals and clearances and which ...

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, ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges. Artificial Intelligence (AI) and Machine Learning ...

How innovators in the femtech space can protect their inventions and defend market share. Depending on scope, estimates for Femtech’s current market size range from $500 million to $1 billion.[4] ...

As generative AI becomes embedded in clinical research, concerns around hallucinated citations and unverified outputs are growing. These inaccuracies are already entering scientific literature, ...

PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities, according to the company Roche, will complement the company’s digital pathology portfolio to ...

Consider a hypothetical scenario that reflects a pattern increasingly reported by manufacturers: a 510(k) submission for an AI-powered diagnostic tool with 99% sensitivity. Strong numbers. Solid ...

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 ...

Market Access is now the central input into M&A and value-driven divestitures, enabling MedTech leaders to reshape portfolios for strategic advantage, long-term growth, and greater value to patients – ...