Medical Innovation Exchange

Medical Device

What They Said – Looking Back at FDA Press Releases During 2022

Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are communicating with the public. Moreover, this year is marked by the fact that the agency …

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Connected Care: Overcoming Roadblocks and Identifying Opportunities

Connected Care: Overcoming Roadblocks and Identifying Opportunities     What’s next—and what’s holding us back—on the road to a truly connected healthcare system? On March 14-15, leaders in digital health will come together at the ConnectedCare Summit East in Washington, DC, to look at best practices, pitfalls and what we’ve learned so far on the road …

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Tackling Go-To-Market Challenges

Tackling Go-To-Market Challenges     The medical device industry is amid an era of unprecedented regulatory complexity. Every 22 minutes, a new or updated regulatory requirement is issued somewhere in the world. All told, this amounts to 22,000 new or updated regulations every year, and it has led to a 150% increase in regulatory mandates over …

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Instilling Trust in AI

Instilling Trust in AI     Artificial intelligence (AI) has become one of the most exciting and promising technologies in health care and MedTech, thanks to its ability to shift through huge volumes of data and quickly detect patterns. As commercial applications for AI continue to expand, questions have been raised regarding privacy, bias and even …

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FDA Seeks Input on Advancing Use of Real-World Data and Evidence

FDA Seeks Input on Advancing Use of Real-World Data and Evidence     The FDA is seeking input from stakeholders on how it should use user fee funding for engaging with external organizations, other than the National Evaluation System for Health Technology (NEST), to support premarket Real-World Evidence. Under the fifth reauthorization of the Medical Device …

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FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices

FDA To Host Webinar on Electromagnetic Compatibility of In Vitro Diagnostic Devices     The FDA is hosting a webinar on February 2 from 1:00-2:00pm ET for interested stakeholders to discuss the final guidance Electromagnetic Compatibility (EMC) of Medical Devices and its applicability to in vitro diagnostic (IVD) devices. The FDA announced that during this webinar it …

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