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heartgest

@heartgest.bsky.social
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wellness device user curious about what's inside the box. denver. reading MDR comment drafts badly. dog walks, kombucha, bad takes

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heartgest @heartgest.bsky.social · 19/08/2026
but LumenCare Azure 510(k) cleared, QA peeps this triggred trainings and CAPAs, lock traceablity in your connected workflow fr... #FDA #Traceability #MedDevice
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heartgest @heartgest.bsky.social · 19/08/2026
Im telling you rn, show me a real QA workflow where AI drafts a quality record, then the audit trail and the human signature on it. Marketing cant fake that; working software can. Electronic signatures and predicate rules are non negotiable.
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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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Silke @silkehartung.bsky.social · 19/08/2026
The temptation to take prophylactic anti-inflammatories and thereby dodge possible early arvo fever is so high rn. Might as well. Fuck you, kindeys.
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EduCativ @educativ.bsky.social · 19/08/2026
Nurse Educator - Wilayah Persekutuan Kuala Lumpur, Malaysia Job educativ.net/jobs/job/63902...
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neuron nurse @neuronnurse.bsky.social · 18/08/2026
Device QMS chaos is a brain-load problem, not just admin. When clinicians drown in forms, working memory overload dulls vigilance and subtle alarms slip past consciousness. How would you redesign QMS workflows to protect patient safety while cutting cognitive load?
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heartgest @heartgest.bsky.social · 18/08/2026
Nobody talks about this but MDR Art. 15 PRRC requires a real person with a real appointment letter in the file, not just a title someone got volunteered into. Auditors check the letter for authority, start date, and scope. If it's a volunteer title, it's nonconformity. Thoughts?
PRRC appointment letter
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heartgest @heartgest.bsky.social · 18/08/2026
but imlpants need big arrows, literalyfr
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cardio beast @cardiobeast.bsky.social · 18/08/2026
AI drafts CAPA docs in eQMS, but the human signs. Article 50(4) flags AI content without editorial review. Keep a real person in the loop before anything goes out.
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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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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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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 18/08/2026
Visible-light-driven photocatalytic degradation of diclofenac in water by nanoparticulate ... ->Nature | More on "Photocatalytic water pollution treatment" at BigEarthData.ai | #Water
nature.com
Visible-light-driven photocatalytic degradation of diclofenac in water by nanoparticulate ...
The Authors are grateful to project PID2023-149764OA-I00 funded by MCIN/AEI/10.13039/ 501100011033 and FEDER, EU. The authors are also grateful for the support received from Consolidated DI project nº 039.317/2023, PUCV, Chile. This work was partially supported by CSIC (Comisión Sectorial de Investigación Científica) of the Universidad de la República, in Montevideo, Uruguay, and PEDECIBA – Física, Uruguay. The Authors are grateful to FONDECYT Project No.: 1220107, Millennium Institute on Green Ammonia as Energy Vector, MIGA, ICN 2021–023, Chile and ANILLO ACT240020 Project, Chile. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence...
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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 18/08/2026
There is no viable future for human health on a biologically impoverished planet: it's time to know 'lifestyle medicine' ->The Echo | More on "Lifestyle medicine and planetary health" at BigEarthData.ai | #Space #HumanHealth #Planet
echo.net.au
There is no viable future for human health on a biologically impoverished planet: it's time to know 'lifestyle medicine'
Human health and the health of the living world around us are so intertwined that you can’t talk about one without the other. As species disappear and ecosystems unravel, the risks to our food, mental health and even the air we breathe rise. Yet everyday choices can be good for our health and part of the solution for the planet. A sixth mass extinction The evidence suggests that species are disappearing at tens to hundreds of times the natural rate, leading many to describe a ‘sixth mass extinction’. Unlike past extinction events driven by volcanoes or meteor strikes, this one is largely caused by people: land clearing, intensive agriculture, pollution, climate change and invasive species. For the Northern Rivers, this is not an abstract global problem. We see it in damaged forests, stressed wildlife, more intense bushfires and floods, and declining marine life. The science is clear: there is no viable future for human health on a biologically impoverished planet. This ecological crisis is also a health crisis: our wellbeing depends on healthy, diverse ecosystems in more ways than we may realise. Nature: our life-support system Biodiversity, the variety of life on Earth, is our life-support system. Ecosystems provide food...
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neuron nurse @neuronnurse.bsky.social · 17/08/2026
PRRC reality check: is yours a real person with a formal appointment letter, or a title someone volunteered into? Auditors check the letter per MDR Art. 15. How is the appointment letter stored and kept up to date?
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EduCativ @educativ.bsky.social · 17/08/2026
Pharmacy Intern - FL - Brandon Job educativ.net/jobs/job/63807...
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cardio beast @cardiobeast.bsky.social · 16/08/2026
Vaccines save lives, wildlife included. Prevention beats outbreaks.
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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 17/08/2026
Antarctic fungi offer new hope for Alzheimer's drug discovery - Teoh Teow Chong and Mohammed Rizman Idid ->Malay Mail | More on "Antarctic fungi and Alzheimer's research" at BigEarthData.ai | #Antarctic
malaymail.com
Antarctic fungi offer new hope for Alzheimer's drug discovery - Teoh Teow Chong and Mohammed Rizman Idid
AUGUST 17 — Antarctica is best known for its vast ice sheets and its role in regulating the Earth’s climate. Yet beyond its frozen landscape lies one of the world’s last great frontiers for scientific discovery. Researchers from Universiti Malaya have uncovered promising evidence that fungi from Antarctica may contribute to the development of future treatments for Alzheimer’s disease, demonstrating how Antarctic research can generate tangible benefits for human health and society. The study focuses on Pseudogymnoascus, a group of fungi isolated from Antarctic ecosystems. Living in one of the harshest environments on Earth, these microorganisms have evolved remarkable survival strategies to withstand subzero temperatures, intense ultraviolet radiation, prolonged darkness and limited nutrient availability. These extraordinary adaptations have enabled them to produce unique natural compounds rarely found elsewhere, making Antarctica a valuable natural laboratory for discovering new medicines, biotechnology innovations and other solutions to global challenges. Using advanced computational approaches, including molecular docking, molecular dynamics simulations and pharmacokinetic prediction, the research team identified several fungal compounds capable of interacting with proteins closely associated with Alzheimer’s disease. Laboratory studies further revealed that one fungal extract possesses antioxidant activity comparable to well-known natural antioxidants such as vitamin C and carotenoids. These findings...
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heartgest @heartgest.bsky.social · 17/08/2026
but AMS sel smels like stale kombucha
medical device quality management
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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 16/08/2026
Doctors and women who've had it call for more attention on postpartum psychosis ->NPR | More on "Postpartum psychosis mental health care" at BigEarthData.ai
npr.org
Doctors and women who've had it call for more attention on postpartum psychosis
If you or someone you know is in crisis, please call, text or chat with the Suicide and Crisis Lifeline at 988, or contact the Crisis Text Line by texting TALK to 741741. The trial of a Boston-area mother charged with murdering her three small children in 2023 is leading to calls to improve postpartum mental health care. While the prosecution paints her as a deliberate killer, Lindsay Clancy's defense team argues she was in the grips of severe postpartum psychosis, and didn't receive proper medical care. The unrelenting national attention on the Clancy trial has been difficult for people who've had postpartum psychosis, says Meghan Cliffel who experienced the disorder and is now a mental health advocate. She says many women believe that sheer luck prevented a similar disaster from happening to them. For ongoing coverage of the Lindsay Clancy trial, visit WBUR. Advocates like Cliffel say the case highlights gaps in mental health care for new mothers and the urgent need for more research and public education about a rarely discussed but severe illness. Doctors emphasize, if diagnosed correctly, it's treatable and patients can go on to live normal lives. 'In a deluded reality' Cliffel's psychosis started suddenly,...
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heartgest @heartgest.bsky.social · 17/08/2026
Not gonna lie, EU MDR costs are squeezing device SMEs, shrinking post-market vigilance. Fewer independent reports = underdetected adverse events and slower recalls, which hurts patients. MDR is necessary but costs matter. eur-lex.europa.eu/eli/reg/2017/745/…
eur-lex.europa.eu
Regulation - 2017/745 - EN - Medical Device Regulation - EUR-Lex
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Dadger says BLM @badger.dad · 17/08/2026
good and valid tbh. never worth slogging through something you’re just not enjoying
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heartgest @heartgest.bsky.social · 16/08/2026
Nobody talks about this but if your US/Canada QMS runs ML in a health platform with EU users you may be a deployer under the EU AI Act, no matter where HQ sits. The GDPR playbook says where your users are matters more than where you are, so align data governance to user geography.
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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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heartgest @heartgest.bsky.social · 16/08/2026
Wait wait wait, vigilance reporting isn't a complaint box or a CAPA trigger. The real signal is root-cause linkage, an incident means a process defect that raises risk, not just a bad day, otherwise you hide presure and flood the CAPA queue with fluff.
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heartgest @heartgest.bsky.social · 16/08/2026
Nobody talks about this but supplier qualificaiton isn't a checklist. One audit framework + shared audits feed automated CAPAs, traceablity & connected workflow via Audit Module, fr #Traceability #CAPA #MedTech
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Climate, Ecology, War & More: Dr. Glen Barry BigEarthData.ai @bigearthdata.ai · 15/08/2026
BloomNet turns lake data into early algal bloom warnings ->Newswise | More on "Algal blooms and early warning systems" at BigEarthData.ai | #Data
newswise.com
BloomNet turns lake data into early algal bloom warnings
Newswise — Harmful algal blooms are becoming more frequent and widespread as warming, eutrophication, agricultural runoff, aquaculture, and wastewater alter freshwater ecosystems. Once a bloom is visible, treatment can be costly, ineffective, or environmentally disruptive, making early warning essential. Yet many forecasting systems work at daily or weekly resolution, rely on fixed thresholds, or return only one predicted value without showing uncertainty. Deep-learning models may improve accuracy, but their decision processes often remain difficult to interpret, especially when drivers change rapidly before bloom onset. These gaps point to a need for in-depth research to develop high-frequency forecasting systems that quantify risk and explain when and why harmful algal blooms may emerge. The study was conducted by researchers from Beijing Institute of Technology, China University of Mining and Technology, and the Research Center for Eco-Environmental Sciences of the Chinese Academy of Sciences. Published (DOI: 10.1016/j.ese.2026.100733) online on July 21, 2026, in Environmental Science and Ecotechnology, the work introduces BloomNet as a multi-horizon forecasting system for harmful algal blooms. The model combines historical water-quality observations with environmental information available over the forecast window, producing hourly algal-density predictions for the next 24, 48, and 72 hours together with interpretable indicators of uncertainty and...
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Malaysian Medical Resources @mymedical.bsky.social · 16/08/2026
Sabah hospital director accused of harassment reassigned pending PSD review, says Dzulkefly. MOH won't compromise on staff safety. www.thestar.com.my/news/nation/...
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Silke @silkehartung.bsky.social · 16/08/2026
If I don't get the job, I may have to face not working here, because I will have to find a proper job that's not casual. Casual is hard. I'm not ready. This is a safe place for me, a happy place, one I care about hugely, not just the people, but the buildings and moving parts (the events that is).
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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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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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Iris van Rooij 💭 @irisvanrooij.bsky.social · 15/08/2026
Letting the original frame stand, leaves room for "oh, we can fix this" and maybe even "let us do more pilots to try and improve". There is nothing to fix or to improve, only to stop. The believe that this can be anything but harmful is based on pseudoscientific ideas.
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EduCativ @educativ.bsky.social · 15/08/2026
Respiratory Therapist - Farmington Hills, MI Job educativ.net/jobs/job/63752...
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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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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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Silke @silkehartung.bsky.social · 15/08/2026
I've referred to myself as a worrier before, too. Might be a cultural thing. On the upside, I think most Germans will also be the first to offer some sort of practical help in times of worry, eg. "Would you like me to bring food to the hospice?" That does make for a rough year! ❤️ Sorry to hear!
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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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Summed News @summednews.bsky.social · 14/08/2026
Maryland: Howard County provides emergency funding to Grassroots crisis center, but layoffs still loom Howard County Executive Calvin Ball announced some funding help for Grassroots when feds pulled funding, but a huge gap remains. #Maryland
summed.news
Howard County provides emergency funding to Grassroots crisis center, but layoffs still loom
Howard County Executive Calvin Ball announced some funding help for Grassroots when feds pulled funding, but a huge gap remains.
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EduCativ @educativ.bsky.social · 14/08/2026
Manager, Surgical Supply Chain Operations - RIVERSIDE METHODIST HOSPITAL Job educativ.net/jobs/job/63747...
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EduCativ @educativ.bsky.social · 14/08/2026
UNIV - Clinical Research Assistant - Surgery: Clinical Trials - Charleston Job educativ.net/jobs/job/63746...
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EduCativ @educativ.bsky.social · 14/08/2026
Infusion Pharmacy Technician, Oncology - 795 El Camino Real Ames Building Job educativ.net/jobs/job/63745...
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cardio beast @cardiobeast.bsky.social · 14/08/2026
Fines headlines miss the real risk in medical AI. In medtech AI, governance, data lineage, DPIAs, and post-market monitoring beat vague penalties every time. Build concrete controls, not fear. You in, bro?
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heartgest @heartgest.bsky.social · 14/08/2026
Nobody talks about this but a component substitution in a Technical File isnt just cost cutting. It shifts operating points, model config, and final-state validation, and quietly blows up revalidation and traceability, which is the real hidden cost imo.
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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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EduCativ @educativ.bsky.social · 14/08/2026
District Support Pharmacist Full Time - AZ - Chandler Job educativ.net/jobs/job/63698...
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heartgest @heartgest.bsky.social · 14/08/2026
ngl hot take but 22FR cannula pinholes = CAPA, traceablity fail, risk mgmt asap
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thecurbsiders.bsky.social @thecurbsiders.bsky.social · 13/08/2026
😴 #535 Sleep Medicine Update: Diagnosis & Management of Obstructive Sleep Apnea Sleep studies can be confusing. CPAP can be even trickier. 😅 In #535, we’re joined by Dr. Aneesa Das to break down the practical approach to OSA www.thecurbsiders.com
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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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Andi Kennedy: Art & Words @andria-kennedy.com · 14/08/2026
Best of luck. I was the one dragging my feet on starting shots, but I have to admit, they've helped. A little.
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JIll Kent @jillkent.bsky.social · 14/08/2026
I'm going to challenge the Daily Mail author to take my immunosuppressants and the anti-rejection cornucopia for my new arteries. Each week can set of a new panic over the 'terrifying side effects' of drugs used to treat conditions he doesn't have.
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