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.

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 ...

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 ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges.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 ...

Behavioral health providers were excluded from the 2009 HITECH Act, which contributed to significant disparities in EHR adoption between mental and physical health providers. The Behavioral Health ...

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 ...

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] ...

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 ...

Merely treating the disease is no longer the goal of the global healthcare system. The entire industry has rearranged itself around the centerpiece called “patients” over the last few years. This ...

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 – ...

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 ...