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, who led the development of the technology, and Dr. Hans Ikenberg, director of one of the first labs to work with the system.
A new survey from the Center for Connected Medicine at UPMC Sheds light on how healthcare systems are navigating both the promise and the possible risk of AI and generative AI.
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).
Emerging technologies, integrated vendor ecosystems and enhanced regulatory compliance will redefine care delivery and shape the needs of healthcare stakeholders. Following are six healthcare technology trends that will shape care delivery and the MedTech market in 2024.
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.
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.
“The V-CHAMPS Challenge showed us that artificial intelligence (AI) models that performed well on the synthetic patient data in Phase 1 also performed well on the RWD during Phase 2, highlighting the potential value of using synthetic data in AI model development.”
“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.”
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.
Medical device regulations change frequently, so companies must be prepared to adapt. Following are strategies organizations can embrace to become more agile, allowing them to thrive amidst these increasingly rapid changes in innovation and regulation.
