LONDON – Long-awaited guidance on how software will be treated under the stricter EU devices regulations brings clarity but also adds to the mountain of preparations needed to comply with the new rules. The vast majority of software products that are treated as class I under the current rules – and therefore self-certified – will be upgraded to class IIa and higher under the Medical Devices Regulation (MDR) coming into effect in May 2020, and the In Vitro Diagnostic Regulation (IVDR), which takes effect May 2022.
HONG KONG – South Korean biotech Deep Bio Inc. has won CE marking for its artificial intelligence (AI)-powered medical software DeepDx-Prostate Connect.
The new draft guidance for clinical decision support (CDS) software is in part a response to the 21st Century Cures Act, and the FDA Bakul Patel said on a Nov. 4 webinar, "we heard the feedback loud and clear" on the previous draft, and thus the agency must "get this policy to a place where it balances patient safety" and the need to avoid unnecessary roadblocks between developers and the market.
BOGOTA, Colombia – A Costa Rican designer developed a system to create tailor-made molds to treat patients diagnosed with microtia, a congenital deformity, in which the external ear is not fully developed. "This is a very basic concept, and it really amazes me that it has not been implemented before," Andrés Quiros, the product designer behind the invention, told BioWorld MedTech.
Mayo Clinic has entered a 10-year partnership with Google "to expand on the more than 200 projects already incorporating artificial intelligence (AI) and machine learning," Mayo Chief Medical Information Officer Steve Peters told BioWorld MedTech. The Rochester, Minn.-based health care organization expects Google's expertise in data science and search technology will help the clinic improve treatment and outcomes by developing machine learning models.
The FDA has reissued a 2017 draft guidance for clinical decision support (CDS) applications as part of a reexamination of software regulations, and one difference between the 2017 draft and the latest iteration that is sure to cheer developers is that the agency now provides much more clarity as to the types of functions that will and will not fall under regulatory scrutiny going forward.
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