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Notified body group raises safety concerns about targeted MDR<IVDR revision

The European Association of Medical devices Notified Bodies (Team-NB) is concerned that some of the targeted revisions planned for the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) to ease post-market surveillance requirements may compromise patient safety.

Smart contact lens monitors eye pressure and delivers glaucoma drugs in early tests:  Battery-free device could overcome downsides of current therapy, study authors say

Rabbit research shows contact lens that senses and treats glaucoma: A smart contact lens tested with rabbits and cow eyes tracked eye pressure and released glaucoma medication when needed, using a design that responds to changes in eye shape, according to a study in Science Translational Medicine. It worked in both normal and high-pressure eyes and could improve treatment by giving more accurate, continuous measurements while reducing the need for daily eye drops.

Massive budget cuts for US science proposed again by Trump administration:  Budget proposal would also curb federal payments for scientific publishing.

Budget plan proposes cuts to science funding: The Trump administration’s 2027 budget proposal includes significant cuts to US science agencies, with the National Science Foundation (NSF) and Environmental Protection Agency (EPA) facing reductions of over 50%. The proposal also suggests eliminating funding for certain National Institutes of Health (NIH) and National Oceanic and Atmospheric Administration’s (NOAA) research offices. The proposal would also prohibit the spending of “federal funds for expensive subscriptions to academic journals and prohibitively high publishing costs unless required by Federal statute or approved in advance by a Federal Agency.” The budget would increase military spending and prioritize research in quantum information and artificial intelligence (AI).

AI (Artificial Intelligence) model designs new treatment candidate for opioid addiction that cuts cravings in rats

While the opioid epidemic is one of the most urgent public health emergencies facing the U.S., new therapeutic approaches for treating the underlying substance use disorder have lagged far behind. Scientists have now used an Artificial Intelligence (AI) program to design a compound that reduced fentanyl use in addicted rats, which could one day serve as a new tool to help patients recover from opioid abuse.

FDA Consolidates Adverse Events Reporting Systems

The US Food and Drug Administration (FDA) announced it is unifying its various Adverse Reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The Agency said the move would modernize adverse event reporting systems and provide more transparency.

Investing in Hope:  A wealthy family fighting its own disease boosted research on a little studied brain protein, progranulin.  Can it spur new dementia treatments?

Family funding accelerates research into frontotemporal dementia: A wealthy family’s investment through the Bluefield Project helped transform research on frontotemporal dementia caused by GRN (a gene that codes for a protein called progranulin ) mutations, driving discoveries about progranulin’s role in brain inflammation and cellular waste recycling and helping launch several clinical trials. Despite setbacks with some of these trials, Bluefield continues to advance biomarker research and patient recruitment, and its founders have also created a new nonprofit to explore alternative therapeutic targets.

Cancer blood tests are everywhere. Do they really work? – Their makers claim they can detect dozens of cancer types — but some scientists say they could be missing many cancers or delivering the wrong diagnosis.

Multi-cancer blood tests offer promise but face skepticism: Multi-cancer early detection blood tests that analyze tumor DNA in the bloodstream are being promoted as a way to detect dozens of cancers from a single sample; however, early trial results, including a large study of the Galleri test, have not yet shown a significant reduction in late-stage cancer diagnoses and have raised concerns about missed cancers and false positives. Experts caution that although advances are being made, MCEDs’ accuracy and ability to improve patient outcomes remain uncertain.

Genetically modified pig liver keeps man alive until human organ transplant:  First time the procedure has been performed on a living person.

In the first reported case of its kind, surgeons in China connected a liver failure patient to a genetically modified pig liver that filtered his blood for nearly three (3) days while he awaited a human transplant. The procedure served as a temporary “bridge” therapy until a donor organ became available, highlighting the potential of xenotransplantation to support patients with severe organ failure.

Stem cells provide a potent treatment for frailty:  Elderly people with frailty, which affects up to one-quarter (1/4) of over-50s, increased their endurance after a single dose of stem cells.

A study published in Cell Stem Cell found that a single dose of mesenchymal stem cells can improve endurance in older adults with frailty. The highest dose resulted in a 20% improvement in a six-minute walk test. The stem cells, derived from donated bone marrow, do not require immunosuppressive medications.