Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency. Attention: If you are a medical device company and you have class II or class III ...

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 – ...

Medtronic reported robust fiscal 2026 results, fueled by strong growth in cardiovascular, medical surgical, and diabetes technologies, while advancing key product launches, regulatory milestones, and ...

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.

Medtronic announced several regulatory milestones for its Hugo robotic-assisted surgery platform, including FDA submissions for general and gynecologic surgery indications and the LigaSure™ RAS ...

New set of 73 Real World Evidence examples illustrate how RWD can support rigorous validation of novel device software functions across multiple disease areas. By: Daniel Caños, Ph.D., MPH, Director, ...

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] ...

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, ...

Regulatory excellence is a crucial aspect of the medical technology industry, which involves complying with strict guidelines, ensuring procedural accuracy, and aligning strategically to navigate 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 ...

Quality culture is a cornerstone of any industry, particularly the healthcare industry where patient lives are at stake. The implications of quality culture extend beyond operational efficiency; they ...