Over the last several months, this blog has covered rapidly advances in AI software that will prepare radiology and pathology reports ready for human review, validation, and sign-out.
Radiology at Lightning Speed
The scale tends to be bigger in radiology, and the benchmarks further. For example, AIDOC gets Breakthrough Status for FIRST READ, meaning it's well along in the FDA review pathway for software that drafts a full reading (ready-to-review) of chest x-rays. And raises $150M (here, here). See also breast ultrasound approval here. See survey here.
Pathology Putters
I'm just back from PathVisions, the digital pathology conference. Here on the pathology side, we see some demo's of "RUO" software that gets close to generating prostate pathology reports.
- But here in Path World, you'd fall out of your chair if a speaker at Path Visions calmly addded that his company was WELLunder FDA review, had WON its FDA breakthrough status, or had raised $150M.
FDA Invests in Exciting Radiology Diagnostic Science
Another way radiology is ahead - FDA gave a $1.3M contract not to develop a particular software, but to create a regululatory science trail to punch out these approvals efficiently - in radiology. (Paradigms, tools, standards, critical path, regulatory science, etc). This makes sense for FDA, since it has tangible softwares (AI DOC, etc) in the review and approval pipeline. for radiology diagnostic reports. (So far as I know, no parallel yet in the halls-of-FDA for pathology).
AI Researches the Cognita FDA AI Contract...500 words *or* 10pp
I asked Chat GPT to research and write up the FDA contract. It did a great job. After seeing its many pages of research, I asked it to file the information as a 500 word memo and as a 10 page full report. As always, these AI reports should not be taken as ground truth but as examples of the current ability to understand a task, pursue it, and write it up.
500 word report on Cognita $1.2M Contract...HERE.
Ten page report on Cognita $1.2M Contract...HERE.
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Schematic -
Pathology, like radiology, needs to view a draft report as the digital output of digitized medicine - not a DICOM file delivered to the pathologist or radiologist.
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Bonus - AMA essay and submission to FDA re regulatory path for LLM SAMD - here, here.
