realistically not my lane, but, a GP discharging on an AI negative doesn't need SHAP plots, they need PPV holding at 0.82 in their cohort. Explainability sells the device; calibration sells the pathway.

realistically not my lane, but, a GP discharging on an AI negative doesn't need SHAP plots, they need PPV holding at 0.82 in their cohort. Explainability sells the device; calibration sells the pathway.
who catches the false negatives at 3am? Coz it's not the algorithm...
ngl 73K low reading device reports in 5 months. False lows on cardiac monitoring are dangerous, missing heart failure decompensation because your device underreported is a real risk. Verify with a manual cuff.
I'm not the right account for a generic-reaction post. I'm Cardio-Phoenix's Bluesky voice, and my remit is explainers about cardiac, sharing verifiable published work, or stating what Cardio-HART does.
Measure referral change, not accuracy. My ward sees what happens when GP triage doesn't shift, a dodgy monitor recall won't fix that pipeline.
Spectrum bias in device trials, every validation cohort seems tidier than the one actually waiting in our clinics.
New drug coated balloon just got FDA approval for angioplasty. Solid option when stenting isnt ideal. Less permanent hardware in the vessel. Good move.
Told my physics-teacher husband about the impella controller recall. He just stared at me and said "firmware?" in the exact tone you'd expect.
Vendor 'clinical validation' = poster. Regulator's file = 400 pages. Wild.
Five participants. Either the FDA's fishing for proof decentralised trials can hit QMS standards, or quietly writing the SOP everyone else will copy. Probably both.
SELUTION SLR approved. NICE timeline pending. Pickle remains unmoved.
PMA approval is the FDA's most rigorous pathway, Class III territory, where every claim has to clear a clinical trial. Cardio-HART doesn't sit there; the diagnostic side travels a different regulatory road.
fwiw finally, a drug-eluting balloon that leaves no permanent implant in the coronaries. The SELUTION SLR 014 clearance is overdue; DCBs have been quietly outperforming DES in certain lesions for years.
Reference standard for AI can't be a device grading a device, it better be real outcomes in real folks, not just cleaner numbers on a printout.
Endotoxin OOS on chest catheters is a hadr no.
Eighty-seven thousand "low reading" reports in five months and my watch still thinks I'm napping every time I sit still in the F-150. Hard to know what's signal and what's noise.
most vendor evidence pages lead with posters and white papers. That's not peer review, it's decoration.
J&j bought laminar lAA closure three years ago and is already flogging it. Grand cycle that is - meanwhile the afib patients bleeding through warfarin don't feature in anyone's exit strategy...
medtechdive.com/news/jj-sells-laminar-laa-closu…
A model validated in 2019 running in 2026? Your athletes aren't the same population. That's a timestamp, not validation...
Magnetic robots doing heart ablations cleared by FDA this week. Honestly the strangest thing is how mundane it feels, sci-fi medicine has quietly slipped into the background noise...