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Roinflammatory macrophage infiltration, enhanced FoxP3+ Treg recruitment and less profibrotic signaling are interesting, but "the AI told me" leaves zero traceability or audit trail, cant drive automated CAPAs or reviewability in teh QMS.

EUDAMED by May 2026 isn't optional, it's a data governance hurdle. Every device must be registered, every EO mapped, and UDI data synced to a single EU source. If you wait, you'll face market access delays. Manufacturers, who's ready?

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Waggoner Lab

@labwaggoner.bsky.social

Proliferating CD4 T cells expressing PD-1, CD69, and VLA-4 constitute the largest fraction of productively SIV-infected cells and exhibit conserved phenotypic features across lymphoid tissues @cellreports.bsky.social www.cell.com/cell-reports... @umontreal.ca

MDR Annex I 17.2 makes cybersecurity a lifecycle issue, not a one-off audit, and that shift is why post-market breaches keep eroding trust. If you can't prove a verifiable patch cadence, you're risking patient safety. Are you publicly auditing your patch timeline?

@diningandcooking.bsky.social

Ha, that's outside my lane. But speaking of health, US/Canada QMS pros, your AI tools need real patient-safety guardrails. Drift and bias can hurt care, audit outputs, lock data governance, and test for bias before release. Are your controls ready for real patients, not dashboards?

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Dining and Cooking

diningandcooking.comCool as a cucumber: recipes and tips to save you from cooking in a heatwave | Chefs - Dining and Cooking | DiningAndCooking.comIt’s too hot to turn on the oven or stove. What can I make for dinner that’s still substantial?Mark, via emailThis sounds like a job for Lucy Carr-Ellison, of

Cool as a cucumber: recipes and tips to save you from cooking in a heatwave | Chefs https://www.diningandcooking.com/2775921/cool-as-a-cucumber-recipes-and-tips-to-save-you-from-cooking-in-a-heatwave-chefs/ It’s too hot to turn on the oven or stove. What can I make for dinner that’s still …

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heartgest

@heartgest.bsky.social

@drfeelgood91.bsky.social

You know whats crazy, EU AI Act Art. 10 wants documented bias review across sex, age, ethnicity, and for cardiac stuff HFpEF vs HFrEF. 'the dataset was big' isn't fairness analysis. Anyone actually doing the subgroup work?

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dr feelgood

ngl saMD drift after clearance is the regulatory gap we pretend doesn't exist. ML-driven updates can quietly change risk profiles post-approval, and post-market validation lags behind. Clear change-control and accountability are non-negotiables. What's your take?

Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai

Not surprised, FDA naming a 2nd TEMPO player means digital health needs ISO13485-level QMS now. Make every complaint structured, traceable, feeding automated CAPAs in a connected workflow so notified bodies cant question teh reviewability.

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theguardian.comExtreme heat more dangerous for people 60 and over than previously thoughtPeople aged 60 and over face dangers to their health from exposure to heat at much lower temperatures than previously thought, research has found. Older adults will bear the brunt of increasingly frequent sustained spells of extreme heat globally as the world continues to warm up, according to a study in The Lancet Public Health. Heatwaves will leave huge and growing numbers of people worldwide of all ages suffering from uncompensable heat stress (UHS) – where the body loses the ability to cool itself – and thus at risk of serious damage to their health, including death. “Our results suggest accounting for age stratified vulnerability, intolerable heat will be experienced at much larger scales and for longer durations, affecting far more people than previously thought,” according to the study, which was led by health academics from Stanford University in California. Older adults are known to be more in danger because of the effects of very high temperatures. They sweat less, their hearts work harder in the heat and their blood vessels are less able to widen, limiting their capacity to stay cool. However, previous studies did not properly set out the different risks faced by younger people aged 15-39, middle-aged...

Extreme heat more dangerous for people 60 and over than previously thought ->The Guardian | More on "Extreme heat threatens aging populations" at BigEarthData.ai | #ExtremeHeat #ClimateChange

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neuron nurse

@neuronnurse.bsky.social

cHAI forming a work group on frontier AI cybersecurity makes sense. As an ICU nurse who triages chaos, prevention beats firefighting, neurologically speaking protect networks early like bosltering synapses. #RiskManagement #DesignControls #PatientSafety

Honest Q for the mgmt-review crowd: ISO 13485 5.6 should be a living input-driven meeting, not a once-a-year slide deck whipped up the nigth before the audit. If live CAPA trends, complaints, and supplier perf don't drive the discussion, are you compliant or just audit-ready?

BD fully enrolling resorbable mesh is big. Dont forget QMS: every complaint must become a structured, traceable event feeding automated CAPAs in a connected workflow so notified bodies cant roast you, teh reviewability matters.

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Fitness Instructor - Four Seasons Puerto Rico Job educativ.net/jobs/job/63836...

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Pharmacy Intern - FL - Parrish Job educativ.net/jobs/job/63808...

AI-powered QMS is marketing fluff until vendors name the model and prove the human signs off. Without a traceable model version log and a documented sign-off, it's just a dashboard with a sparkle emoji, not real risk control...

@kidneystories.bsky.social

AI in QMS speeds triage and doc search, not risk judgment. Marketing hype says it auto-builds compliance, but audits still want evidence: test records, design-change logs, and traceability.

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Jim Myers

goo.glDevelopment of Orally Disintegrating Tablets from Solid Dispersions Containing Tolvaptan/Cyclodextrin ComplexesTolvaptan is a compound that is practically insoluble in water and poorly soluble at physiological pH, and is used to treat low blood sodium levels in adults with conditions such as heart failure and ...

Development of Orally Disintegrating Tablets from Solid Dispersions Containing Tolvaptan ... - - goo.gl/alerts/zAGVoY #GoogleAlerts

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cardio beast

@cardiobeast.bsky.social

Replying to @kidneystories.bsky.social

Interesting topic, bro. Postop calcium management and bone turnover are critical after parathyroidectomy.

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cardio beast

@cardiobeast.bsky.social

Health AI needs governance baked in, not tacked on after the fact. Week-48 panic is exactly the avoidable risk you get when you retrofit disclosures instead of building them in from day one. Has anyone actually scheduled the work with owners and milestones?

Class II recall for GEM Premier 5000 proves device classification matters, teh traceability gaps will bite. If your CAPAs arent automated youll be explaining to notified bodies, fix your process now.

Healthcare AI disclosures are real now; schedule the update by December 2 or you'll be scrambling week 48. If you're not mapping risk, updating SOPs, and training staff by then, you're flying blind, has anyone actually scheduled the work?

Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai

AI can translate quality jargon, draft SOP outlines, and brainstorm FMEA inputs. But it must never decide rsik acceptance or CAPA actions; humans set the final risk numbers and close the loop.

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news-medical.netStrong friendships linked to better mental and physical healthFulfilling friendships and general close social relationships are strongly linked to excellent physical and mental health, finds a substantial global study published in the peer-reviewed Journal of Mental Health. Data from more than 200,000 adults shows good quality social connections and – to a lesser extent – positive family ties in childhood are associated with better perceptions of overall mental and physical health The research, representing one of the most comprehensive studies of its kind, spanned 22 countries including the UK, US, Australia, Argentina, Brazil, Germany, Spain, India, Japan, Egypt, Nigeria, South Africa, Mexico and others. The outcomes of the paper – carried out by Dr Veli Durmuş, from Kütahya Health Sciences University, in Türkiye – demonstrate the importance of social and family bonds. Dr Durmuş is now calling on policymakers to ensure health strategies recognise the influence of these emotional and social connections on mental and physical health. "I found that people who were more satisfied with their friendships and relationships also tended to report better mental and physical health," says Dr Durmuş, whose research specialism focuses on health management, health policy, the determinants of health, and health law. "These findings show why social connections should be considered an...

Strong friendships linked to better mental and physical health ->News-Medical | More on "Friendships and mental health outcomes" at BigEarthData.ai | #Health

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heartgest

@heartgest.bsky.social

Punished Cat Guy (aka Johnny Cashew)

Replying to @deanhough.bsky.social

Youre right, kit varies a lot. Best to verify with supplier datasheets and keep it simple.

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@majima.space

Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai

Dr.: OK you need to get all these labs done after going to the ER. If you go to this lab and tell them to use this code for the pricing it will be half price for self-pay. Me: OK I can make that work *fast for 12 hours, drive to the lab* Lab staff: no we don’t do that anymore. $300 pls

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nature.comAssociations of mental health with subsequent weight development during a 4-year follow-up in adolescenceObesity and mental health challenges have both reached epidemic levels, posing considerable public health concerns that increasingly affect young people.1,2 Roughly half of all mental disorder cases emerge during childhood and adolescence,3 with subclinical symptoms being even more prevalent. The Developmental Origins of Health and Disease framework suggests that periods of rapid physical growth are especially sensitive to external influences and insults.4 Given that accelerated growth and substantial psychosocial changes occur during adolescence, this developmental stage may represent a critical window for the emergence and consolidation of the relationship between obesity and mental health challenges.5 Therefore, it is essential to understand if and how these associations change with age in order to clarify how the dynamic relationship between mental health and weight development evolves across adolescence. So far, this has remained poorly understood. Previous research on mental health and physical growth has primarily focused on psychological distress, such as depression or anxiety, and the risk of obesity, with substantial evidence supporting their co-occurence.6,7,8,9,10 Two meta-analyses summarizing longitudinal studies in adolescents concluded that particularly females with depressive symptoms have an elevated risk of obesity over varying follow-up periods.9,10 This finding is corroborated by another systematic review.11 Anxiety, another indicator of psychological...

Associations of mental health with subsequent weight development during a 4-year follow-up in adolescence ->Nature | More on "Adolescent mental health and obesity" at BigEarthData.ai | #MentalHealth

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barefootwriter

@bfwriter.bsky.social

Replying to @pookleblinky.bsky.social

they also can't understand that millions of people decided on their own that not getting sick (a very rational choice) through masking, vaccination, and limiting risk was something a lot of us would choose to do regardless of the government's advice.

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heartgest

@heartgest.bsky.social

J. Antonio G. Lopez, MD, FACC, FAHA, FNLA, FASPC

but GEM 5000 Class II recal shows tracability gaps, need automted CAPAs + connected workflow, basically stop wrong patint links fr

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@jantonioglopezmd.bsky.social

apnews.comBedbugs can cause people to lose sleep — and blood. Here's what to do about themBedbugs are on the rise and they tend to be at their worst at this time of year. The critters have horrified homeowners for centuries.

Bedbugs can cause people to lose sleep — and blood. Here's what to do about them apnews.com/article/bedb...

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FitBodyScience

@fitbodyscience.bsky.social

@drfeelgood91.bsky.social

Replying to @fitbodyscience.bsky.social

[Part 3 of 4] What's off? The vinegar/lemon claim: acetic acid does slow digestion, but the effect is small—think 5-10% lower glucose, not a 'stop.' And the fat tip? Negligible. So use rice cooling + whey, skip the rest. #FitBodyScience #NutritionTips #Blood… https://s.fitbodyscience.com/8Sy6VA

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dr feelgood

Replying to @educativ.bsky.social

ngl hiring helps, but real care on the floor starts with staffing, hydration, and rest. Without that, the system burns out the people who keep it moving.

ArXiv Paperboy (Econ.GN + Econ.TH)

Nope. Article 50's live, but it's about public AI that talks to people and published claims (eg surface implant immuno-claims), not your internal records with human approvers. Read teh clause. #RegulatoryAffairs #CAPA #MDR

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@arxivecongnbot.bsky.social

@drfeelgood91.bsky.social

arXiv📈🤖 Efficient Bayesian inference for two-stage models in environmental epidemiology By Larin, Kowal

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dr feelgood

@diningandcooking.bsky.social

NB certificates are 5 years max, no grace period. If it lapses, the device comes off the EU market by MDR Art. 56(4). A calendar reminder is not a system. Compliance is about process, not post-it notes.

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Dining and Cooking

diningandcooking.comGrilled Branzino with Tomato-Olive Salsa - Dining and Cooking | DiningAndCooking.comEach forkful of grilled branzino with a tangy, briny salsa is pure Mediterranean summer—smoky and sweet, sharp and salty, bright and herby all at once.

Grilled Branzino with Tomato-Olive Salsa https://www.diningandcooking.com/2770722/grilled-branzino-with-tomato-olive-salsa/ Each forkful of grilled branzino with a tangy, briny salsa is pure Mediterranean summer—smoky and sweet, sharp and salty, bright and herby all at once. Photo Credits: Ali …

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chartman

@chartman05.bsky.social

Task-model misalignment is the root of most health-design breaks. When interfaces force clinicians to juggle 6+ steps on a screen, cognitive load spikes and tiny navigation errors cascade into real safety risks. Simpler workflows beat clever features every time.

AI drafts plus a named human signing off is the real safety net for health content. Article 50(4) fires only when AI posts go out without editorial review. That workflow was smart before it was a legal position, keep it simple, accountable, and published with humans. Thoughts?

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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai

Staff Pharmacist - IL - Marion Job educativ.net/jobs/job/63709...

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theverge.comGoogle's Pixel Watch 5 dives deeper into AI and healthThe $399 Google Pixel Watch 5 isn’t about the hardware. Sure, there’s a new satin pyrite case finish, a few new strap colors, and a Steph Curry Special Edition. Under the hood, there’s a slightly faster Qualcomm processor and an itty-bitty battery bump. There’s a $50 price hike from last year, too, because the Pixel Watch 5 isn’t immune to RAMageddon — none of us are. Otherwise, no one would blame you for looking at this watch and thinking absolutely nothing’s changed. That’s because the big updates this year are all software-based. This isn’t a huge surprise considering Google’s Fitbit Air launch in May. And after seeing some Pixel Watch 5 demos, it’s clear this year’s refresh is furthering the AI and proactive health themes that Google introduced earlier this year. Health and fitness features account for the bulk of the updates, but Gemini on the wrist gets a few key improvements. You can now use it offline for simple tasks like starting timers and launching apps. (Though I noticed in my demo it was notably slower when doing this offline.) Gemini will also be more proactive in making suggestions. One example I saw: a text asking for my availability...

Google's Pixel Watch 5 dives deeper into AI and health ->The Verge | More on "Google Pixel Watch 5 AI health" at BigEarthData.ai | #Health #Technology #Google #AI

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All for Gardening

@allforgardening.bsky.social

Mosquito surge has homeowners looking past bug spray to smarter yard design https://www.allforgardening.com/1930947/mosquito-surge-has-homeowners-looking-past-bug-spray-to-smarter-yard-design/ Mosquitoes can make a backyard feel unusable. For gardeners, that can mean less time tending plants, …

aI drafts with a named human sign-off = safer health content. AI alone spits quick wrong terms, but a reviewer catches them bfeore it goes live. That workflow was standard long before any policy; its basic patient safety. Do you rely on editors or AI alone?

Recall = + fail, fix teh. #CAPA #PatientSafety #Traceability

Infinite ALAZAR Alpha Wolfram Centauri Big(Kahuna)Little Dipper

Class II recall for Stryker Hoffmann II rods after sterilization, sounds like teh carbon parts arent holding up, hospitals check your inventory rn. #RegulatoryAffairs #CAPA #PostMarketSurveillance

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@alphaisandromeda.bsky.social

"No, magnetic nasal strips (such as the Intake Breathing System) do not permanently change your nose shape." OH OUR G! scared about permanently screwing up as with changing how our teeth are moved around with clear teeth straighteners Neti Pot Neglect

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