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.

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 ...

Artificial intelligence is already inside regulatory affairs functions across the medtech industry. Teams are using it to summarize guidance documents, support first-pass drafting, compare labeling ...

Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare ...

Billions of dollars are lost annually in medical billing errors resulting from data entry mistakes, outdated coding practices, and duplicated charges.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

What 524B and QMSR actually require, in plain terms, including the post-market obligation that does not end at clearance? How both map to four kinds of exposure: cybersecurity, product liability, ...

Strategic Evaluation Criteria (Weighted) Once the threshold criteria are satisfied, the following factors can be analyzed and weighed according to the specific context of the technology and the ...

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s ...

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, ...

Companies that embed Market Access early in innovation are the ones best positioned to navigate the changing global landscape. Across industry, the Market Access (MA) function has evolved well beyond ...

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 ...