The Medical Futurist
JUNE 21, 2025
Finally, the arrival of interoperability can connect and harmonise various hospital systems An M-LLM could serve as a central hub that facilitates access to various unimodal AIs used in the hospital, such as radiology software, insurance handling software, Electronic Medical Records (EMR), etc.
FDA Law Blog
SEPTEMBER 22, 2024
MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. SCG : Modified version of another manufacturer’s FDA-authorized test within scope described in preamble to LDT Final Rule. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)
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The Medical Futurist
JUNE 21, 2025
While it is really difficult to manufacture a contact lens, which is one-third of a millimetre in diameter, a 3D printer sandwiches together different layers of interacting material, which makes it easier to match tiny pieces. and a specificity of 95.5%. The use of Orca Health’s EyeDecide could bring exactly this result.
FDA Law Blog
JULY 7, 2024
Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 806) and Complaint Files (21 C.F.R.
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