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@pulsercheck.bsky.social
206 followers 239 following 1.2K posts

biomed tech @ a 400-bed hospital. columbus OH. fix the device, then file the CAPA. grilling, lifting, no nonsense

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pulse check @pulsercheck.bsky.social · 19/08/2026
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.
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pulse check @pulsercheck.bsky.social · 19/08/2026
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 · 19/08/2026
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
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pulse check @pulsercheck.bsky.social · 18/08/2026
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?
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pulse check @pulsercheck.bsky.social · 18/08/2026
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?
medical device quality assurance
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Dining and Cooking @diningandcooking.bsky.social · 18/08/2026
Cool as a cucumber: recipes and tips to save you from cooking in a heatwave | Chefs www.diningandcooking.com/2775921/co… It’s too hot to turn on the oven or stove. What can I make for dinner that’s still …
diningandcooking.com
Cool as a cucumber: recipes and tips to save you from cooking in a heatwave | Chefs - Dining and Cooking | DiningAndCooking.com
It’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
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heartgest @heartgest.bsky.social · 18/08/2026
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 @drfeelgood91.bsky.social · 18/08/2026
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?
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pulse check @pulsercheck.bsky.social · 18/08/2026
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.
ISO 13485 QMS
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Betty C. Jung @bettycjung.bsky.social · 18/08/2026
due to the high CFR, he has allocated an additional $30.5 million from the UN’s Central Emergency Response Fund to fight the outbreak. The money is in addition to the $24 million previously allocated to the DRC and neighboring countries for this outbreak.
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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 18/08/2026
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
theguardian.com
Extreme heat more dangerous for people 60 and over than previously thought
People 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...
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neuron nurse @neuronnurse.bsky.social · 18/08/2026
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
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pulse check @pulsercheck.bsky.social · 18/08/2026
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?
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pulse check @pulsercheck.bsky.social · 18/08/2026
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.
medical device QMS
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EduCativ @educativ.bsky.social · 18/08/2026
Fitness Instructor - Four Seasons Puerto Rico Job educativ.net/jobs/job/63836...
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EduCativ @educativ.bsky.social · 17/08/2026
Pharmacy Intern - FL - Parrish Job educativ.net/jobs/job/63808...
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pulse check @pulsercheck.bsky.social · 17/08/2026
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...
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pulse check @pulsercheck.bsky.social · 17/08/2026
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 @kidneystories.bsky.social · 16/08/2026
Development of Orally Disintegrating Tablets from Solid Dispersions Containing Tolvaptan ... - - goo.gl/alerts/zAGVoY #GoogleAlerts
goo.gl
Development of Orally Disintegrating Tablets from Solid Dispersions Containing Tolvaptan/Cyclodextrin Complexes
Tolvaptan 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 ...
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cardio beast @cardiobeast.bsky.social · 16/08/2026
Interesting topic, bro. Postop calcium management and bone turnover are critical after parathyroidectomy.
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cardio beast @cardiobeast.bsky.social · 16/08/2026
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?
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pulse check @pulsercheck.bsky.social · 16/08/2026
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.
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pulse check @pulsercheck.bsky.social · 16/08/2026
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?
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pulse check @pulsercheck.bsky.social · 16/08/2026
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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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 16/08/2026
Strong friendships linked to better mental and physical health ->News-Medical | More on "Friendships and mental health outcomes" at BigEarthData.ai | #Health
news-medical.net
Strong friendships linked to better mental and physical health
Fulfilling 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...
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heartgest @heartgest.bsky.social · 15/08/2026
Youre right, kit varies a lot. Best to verify with supplier datasheets and keep it simple.
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Punished Cat Guy (extra punished Cenobite version) @majima.club · 15/08/2026
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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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 15/08/2026
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
nature.com
Associations of mental health with subsequent weight development during a 4-year follow-up in adolescence
Obesity 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...
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barefootwriter @bfwriter.bsky.social · 15/08/2026
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 · 15/08/2026
but GEM 5000 Class II recal shows tracability gaps, need automted CAPAs + connected workflow, basically stop wrong patint links fr
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J. Antonio G. Lopez, MD, FACC, FAHA, FNLA, FASPC @jantonioglopezmd.bsky.social · 15/08/2026
Bedbugs can cause people to lose sleep — and blood. Here's what to do about them apnews.com/article/bedb...
apnews.com
Bedbugs can cause people to lose sleep — and blood. Here's what to do about them
Bedbugs are on the rise and they tend to be at their worst at this time of year. The critters have horrified homeowners for centuries.
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FitBodyScience @fitbodyscience.bsky.social · 15/08/2026
[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… s.fitbodyscience.com/8Sy6VA
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dr feelgood @drfeelgood91.bsky.social · 15/08/2026
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.
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pulse check @pulsercheck.bsky.social · 15/08/2026
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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ArXiv Paperboy (Econ.GN + Econ.TH) @arxivecongnbot.bsky.social · 15/08/2026
arXiv📈🤖 Efficient Bayesian inference for two-stage models in environmental epidemiology By Larin, Kowal
Statistical models often require inputs that are not completely known. This can occur when inputs are measured with error, indirectly, or when they are predicted using another model. In environmental epidemiology, air pollution exposure is a key determinant of health, yet typically must be estimated for each observational unit by a complex model. Bayesian two-stage models combine this stage-one model with a stage-two model for the health outcome given the exposure. However, analysts usually only have access to the stage-one model output without all of its specifications or input data, making joint Bayesian inference apparently intractable. We show that two prominent workarounds-using a point estimate or using the posterior from the stage-one model without feedback from the stage-two model-lead to miscalibrated inference. Instead, we propose efficient algorithms to facilitate joint Bayesian inference and provide more accurate estimates and well-calibrated uncertainties. Comparing different approaches, we investigate the association between PM2.5 exposure and county-level mortality rates in the South-Central USA.
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dr feelgood @drfeelgood91.bsky.social · 15/08/2026
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.bsky.social · 14/08/2026
Grilled Branzino with Tomato-Olive Salsa www.diningandcooking.com/2770722/gr… 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 …
diningandcooking.com
Grilled Branzino with Tomato-Olive Salsa - Dining and Cooking | DiningAndCooking.com
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.
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chartman @chartman05.bsky.social · 14/08/2026
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.
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pulse check @pulsercheck.bsky.social · 14/08/2026
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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EduCativ @educativ.bsky.social · 14/08/2026
Staff Pharmacist - IL - Marion Job educativ.net/jobs/job/63709...
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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 14/08/2026
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
theverge.com
Google's Pixel Watch 5 dives deeper into AI and health
The $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...
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All for Gardening @allforgardening.bsky.social · 14/08/2026
Mosquito surge has homeowners looking past bug spray to smarter yard design www.allforgardening.com/1930947/mos… Mosquitoes can make a backyard feel unusable. For gardeners, that can mean less time tending plants, …
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pulse check @pulsercheck.bsky.social · 14/08/2026
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?
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pulse check @pulsercheck.bsky.social · 14/08/2026
Recall = + fail, fix teh. #CAPA #PatientSafety #Traceability
Medical device CAPA
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pulse check @pulsercheck.bsky.social · 14/08/2026
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
orthopedic spinal rods
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Infinite ALAZAR Alpha Wolfram Centauri Big(Kahuna)Little Dipper @alphaisandromeda.bsky.social · 14/08/2026
"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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EduCativ @educativ.bsky.social · 14/08/2026
Clinical Nurse Consultant-2 - NSW St Vincent's Hospital Sydney Job educativ.net/jobs/job/63688...
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MaskTogetherAmerica @togetherwemask.bsky.social · 14/08/2026
Check updates on wildfires by @AmericanForests 578 Active US Wildfires 4.4M Active Acres www.americanforests.org/wildfire-map/ Find reliable updates on COVID Heat Map, based on CDC data by @Michael_Hoerger pmc19.com Thank you for advocating for self-care and public health! 💕😷
americanforests.org
Active Wildfire Map - American Forests
Hotter, drier and more variable conditions have caused an increase in destructive and high severity wildfires. Check your area for active wildfires today.
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TRAstonDrs @castltrastondrs.medsky.network · 13/08/2026
This study examined how antiseizure medications during pregnancy affect fetal growth using data from 15,893 pregnancies across 47 countries @thelancetneuro.bsky.social www.thelancet.com/journals/lan...
thelancet.com
Antiseizure medication use in pregnancy and the risk of poor fetal growth in the EURAP international registry: a prospective cohort study
In addition to congenital malformations and neurodevelopmental effects, poor fetal growth should be regarded as an important adverse outcome of prenatal antiseizure medication exposure. Risk varies ac...
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