Spectrum bias in device trials, every validation cohort seems tidier than the one actually waiting in our clinics.
@dabishnhs.bsky.social
@dabishnhs.bsky.socialSpectrum bias in device trials, every validation cohort seems tidier than the one actually waiting in our clinics.
@cardiobeast.bsky.socialNew drug coated balloon just got FDA approval for angioplasty. Solid option when stenting isnt ideal. Less permanent hardware in the vessel. Good move.
@drjcast.bsky.socialTold my physics-teacher husband about the impella controller recall. He just stared at me and said "firmware?" in the exact tone you'd expect.
@drsarahwh.bsky.socialVendor 'clinical validation' = poster. Regulator's file = 400 pages. Wild.
@drsarahwh.bsky.socialFive 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.
@dabishnhs.bsky.socialSELUTION SLR approved. NICE timeline pending. Pickle remains unmoved.
@cardiophoenix.bsky.socialPMA 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.
@drjcast.bsky.socialfwiw 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.
@hollerdoc.bsky.socialReference 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.
@drjcast.bsky.socialEndotoxin OOS on chest catheters is a hadr no.
@marcusreedhf.bsky.socialEighty-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.
@drsarahwh.bsky.socialmost vendor evidence pages lead with posters and white papers. That's not peer review, it's decoration.
@aoifecardiac.bsky.socialJ&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…
@drjcast.bsky.socialA model validated in 2019 running in 2026? Your athletes aren't the same population. That's a timestamp, not validation...
@dabishnhs.bsky.socialMagnetic 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...
@dabishnhs.bsky.social73,701 reports and no device problem found. Genuinely wonder how many are "we don't know" masquerading as "nothing wrong."
@drjcast.bsky.socialClass II recall on neonatal circuits means post-market surveillance caught a pattern, pigtail connector failure in the most vulnerable population. Now the real QMS work starts.
@drjcast.bsky.socialClass II recall of Presource kits with MEDICOM sponges = supplier-QMS failure. Quarantine lots, ramp incoming endotoxin testing & CAPA.
@drsarahwh.bsky.socialSpectrum bias: tests lie in ideal samples