Author: Rita King

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Regulating Medical Devices Shapes Industry for the Better

This article originally appeared in Business Worldwide magazine. It’s fashionable to be anti-regulation in business today. But sometimes regulation is central to how a sector operates. We talk to Rita King, CEO of MethodSense and Russ King, President of MethodSense about why regulating medical devices and biotech/pharma companies is so critical. Most devices and innovations need to...
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MethodSense Inc. CEO WiMethodSense Inc. CEO Wins Global Leadershipns Global Leadership Award with Business Worldwide Magazine

We are pleased to announce that CEO Rita King was named “Healthcare CEO of the Year – USA” by Business Worldwide Magazine. Full text of the press release is below… LONDON, October 4, 2018 /PRNewswire. The chief executive of life science consulting firm MethodSense has gained global recognition for outstanding leadership in the Business Worldwide Magazine...
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Artificial Intelligence and the FDA

The tech world is exploding around the realities and possibilities of Artificial Intelligence (AI). Artificial Intelligence makes it possible for machines to learn from experience, adjust to new inputs and perform human-like tasks reflecting what we normally think requires natural intelligence.  There are currently relatively few FDA cleared products that use Artificial intelligence on the market.  But...
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Medical Device User Fees (MDUFA)

FDA Announces FY 2018 MDUFA Fees

MDUFA Fee Increases and FDA Small Business Certification The FDA has recently announced the fee rates and procedures for medical device user fees for fiscal year 2018 in the Federal Register. Under the FD&C Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA is authorized to collect user fees...
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FDA Recognized Consensus Standards

FDA Announces New Policy for Accepting Consensus Standards for Medical Devices

FDA Streamlines Process for Accepting Consensus Standards We are seeing the impact of the 21st Century Cures Act yet again with FDA’s clarification on how they will process requests for recognition of consensus standards. With this new policy, FDA has streamlined the process that allows medical device manufacturers to submit a request to the FDA...
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Top Life Science Technology Vendors

MethodSense Named Top 25 Life Science Technology Vendors

CIO Applications recognizes MethodSense as Top Life Science Technology Vendors Amidst technological innovations, regulatory changes, and increased reliance on patient-centric models, there seems to be a multitude of growth opportunities for life sciences companies. Life sciences undoubtedly remain one of the industries that see rapid technological evolution ahead of them. Even though life sciences has...
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Digital Health Unit

FDA to Create a Digital Health Unit

The FDA has announced that it is forming a digital health unit within the Center for Devices and Radiological Health (CDRH). The digital health unit will develop software and technical expertise to assist manufacturers with devices that incorporate digital health technologies, as well as assessing digital health improvements and monitoring and reporting on the digital...
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