As more stakeholders become involved with automation, AI, and general data management in healthcare applications, the move toward a combination of all three aspects will create healthcare solutions equivalent to sci-fi aspirations.
Thanks to the huge culture surrounding comic books and Japanese manga, a rich body of work has emerged investigating the comprehension of visual narratives. Here, we explain how some of the cognitive principles and theories resulting from this research can be straightforwardly applied to QRGs.
Transcatheter mitral valve devices will continue to expand into clinical practice as people age out of open-heart surgical operations, and technology and innovation for mitral valve diseases will continue to improve.
Can we optimize clinical trial design by considering patients’ urgency for new therapeutic options, as well as their willingness to accept uncertainty? A nearly two-year collaboration — between the FDA Center for Devices and Radiological Health (CDRH), Parkinson’s patients (via The Michael J. Fox Foundation Patient Council), MIT, RTI Health Solutions, and the Medical Device Innovation Consortium (MDIC) — aimed to find out.
How will changes to the ISO 14971, the medical device risk management standard, and its accompanying guidance document, ISO TR 24971, an ISO Technical Report, affect your company?
A medtech seeking payer coverage can only really control its own ability to articulate and prove its technology’s market value, while anticipating the myriad variations in coverage requirements. Virtually everything — from stakeholders to priorities to standards for evidence — is subject to change.
As the minimally invasive approach continues to become standard procedure, demand for surgical visualization equipment will continue to rise. Continued adoption of 4k technology is bolstering growth in the total U.S. video and integrated operating room equipment market, which currently is valued at almost $2.3 billion.
Medical devices released into the market are part of an evolving software and security ecosystem in which new vulnerabilities are discovered or introduced all the time. The FDA's Medical Device Safety Action Plan outlines evolving expectations for the medical device industry, including expectations for secure updates.
Bilingual U.S. board-certified physicians who have a track record of research and publications and and the fact that trial costs are significantly lower in the region, makes Latin America very attractive for U.S. life sciences companies looking to conduct cost-effective and ethical OUS clinical trials.
Given the level of regulation in the sector and the significant responsibility of assisting in patient care, it’s important that innovators, providers, and other parties involved have a high-level understanding of both the benefits and the limitations of AI technology.
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