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UK Flag

MHRA Announces New UK Approved Bodies

By MedTech Intelligence Staff

LNE-GMED UK has been designated as a UK Approved Body to assess and certify general medical devices in accordance with Part II of the UK Medical Devices Regulations 2002. Scarlet NB UK has been designated with a focus on assessing and certifying software and AI as a medical device (AI/SaMD).

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Neeraj Mainkar
Neeraj Mainkar

Advancements in AI: Shaping the Future of Spine Surgery

By Neeraj Mainkar

While AI is already making significant contributions to pre-operative planning and post-operative analysis, its utilization intra-operatively remains a key area for further development. Collecting and utilizing comprehensive intra-operative surgical data, as facilitated by innovative applications of existing technologies such as light field, will pave the way for advanced AI applications in spine surgery.

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PreciseDX
PreciseDX

How AI Can Advance Breast Cancer Detection and Treatment

By Ted M. Diehl, Wayne Brinster

The integration of artificial intelligence (AI) into breast cancer detection and treatment is already making a profound impact. AI-powered algorithms enhance early detection by analyzing vast amounts of data and identifying subtle abnormalities often invisible to the human eye. These technologies empower healthcare professionals to make informed decisions, improving the accuracy of diagnoses and tailoring treatment plans to the specific genetic makeup and health conditions of individual patients. This integration represents a paradigm shift in the cancer care continuum.

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UK Flag

MHRA Releases Roadmap of Future UK Medical Device Regulation

By MedTech Intelligence Staff

“The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health. The roadmap sets out how we will work with stakeholders, including patients, as the process moves forward.”

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NIST logo
NIST logo

NIST Seeks Input on Development and Use of AI

By MedTech Intelligence Staff

The National Institute of Standards and Technology (NIST) is seeking input from industry to support its response to President Biden’s Executive Order on AI. Comments, which are due February 2, 2024, will help NIST develop guidelines for evaluation and red-teaming, consensus-based standards and more.

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