Know What's Happening in Healthcare
Know What's Happening in Healthcare
FDA approves KRESLADI, first CIRM‑backed gene‑editing therapy
The FDA cleared KRESLADI, a gene‑editing treatment from Rocket Pharmaceuticals for severe leukocyte adhesion deficiency‑I in children, eliminating the need for a bone‑marrow donor. It is the first product directly funded by California’s Institute for Regenerative Medicine to receive approval.
Also developing:
By the numbers: Syneron Bio raises $150M Series B
The FDA has rebranded 21 CFR Part 820 as the Quality Management System Regulation (QMSR), effective February 2 2026, and formally incorporated ISO 13485:2016 by reference. The revision trims the regulation to only Subparts A (General Provisions) and B (Supplemental Provisions), directing manufacturers to the ISO standard for the remaining requirements. QMSR also links compliance to other FDA parts such as 803, 806, 821 and 830, making non‑conformance a basis for adulteration findings. The agency provides a QMSR Resource Hub to guide firms through the transition.
I did placenta encapsulation with my first baby due to my prior midwife's recommendation, but I no longer do it or recommend it. Here's why. The only placebo-controlled trials on it (UNLV) found no meaningful benefit for mood, fatigue, bonding, or iron...
Synergy Spine Solutions secured FDA pre‑market approval for its Synergy Disc, the first artificial cervical disc that simultaneously improves spinal alignment and preserves full range of motion. The device features a patented interrupted‑articulation geometry that creates a low‑energy, lordotic position...
Geographic atrophy (GA) management is poised to benefit from AI‑driven OCT analysis, which can quantify ellipsoid zone (EZ) loss, EZ‑RPE ratio, and EZ thickness with micron‑level precision. In Europe, imaging tools like the Topcon GA Monitor are approved, while the...
Heartflow announced that its AI‑enabled Plaque Analysis software will be highlighted in three ACC.26 presentations, showcasing data from a 15,000‑patient CCTA registry that predicts major adverse cardiovascular events. A separate DECIDE registry of nearly 3,800 patients demonstrated that AI‑guided care...
At HIMSS26, healthcare leaders highlighted the promise of agentic artificial intelligence to automate routine tasks such as prior authorizations, scheduling, and patient outreach. They warned that the technology’s independent decision‑making can introduce workflow risks if left unchecked. Effective deployment hinges...
CASPR announced three senior hires: Director of Research, Director of Policy, and Policy Lead. The research director will lead scientific collaborations, identify clinical trial opportunities, and ensure evidence‑based policy. The policy roles will advance legislative initiatives, including NIH trial funding...
The Democratic Republic of Congo is rapidly reshaping its health financing by mobilising domestic resources and tightening public financial management. Core health allocations now exceed 5.5 trillion Congolese franc, while new revenue streams – a 2 % import levy and a mandatory...
I'm not going to comment on the specific stats here because I haven't read the book yet and some of these numbers need more context. But the broader point matters. Women deserve full transparency before making a decision that costs $15-20K...
Medical lasers rely on rare earth elements for their core components, enabling precise wavelength-specific energy delivery that reduces bleeding and speeds recovery. Elements such as neodymium, erbium, holmium, ytterbium and yttrium are doped into laser crystals, while dysprosium, terbium and...
Choosing a medical alert device hinges on response speed, coverage, and usability. Consumers must evaluate 24/7 monitoring centers, in‑home versus mobile signal range, and the reliability of fall‑detection sensors. Design factors such as comfort, waterproofing, and battery life affect daily...
HIMSS had a cat pit, a robot hand on someone's head, and an AI announcement from basically every vendor alive. But we liked other subtler stories: @HeyEpic soft-launching a pharmacy network product that perhaps could eventually take on @Surescripts, a...
Doctors who take their time with each patient >>>> I know it can depend on their schedule, but our pediatrician took 45 minutes with us and it was so helpful
U.S. physicians are increasingly relocating to Canada, driven by frustration with insurance‑driven bureaucracy and high patient out‑of‑pocket costs in the United States. Recruitment firm CanAm reports a 65 % surge in inquiries during the early Trump administration, while the Medical Council...
Structure Therapeutics announced positive topline data from its ACCESS II trial of aleniglipron, an oral small‑molecule GLP‑1 receptor agonist. The study demonstrated statistically significant reductions in HbA1c and weight loss comparable to injectable GLP‑1 therapies. Safety signals were mild, with few...
In 2022 32Co launched as a premium orthodontic aligner platform, then expanded in 2026 with Aerox Health, a dedicated sleep‑medicine brand. The company leveraged an existing dentist network to address the under‑served UK sleep‑apnoea market, applying the same clinical engine...
CytomX Therapeutics’ shares surged 66% after the company released expansion data from its Phase 1 study of Varseta‑M, a masked antibody‑drug conjugate targeting EpCAM in late‑stage colorectal cancer. The trial evaluated three dose levels, with the two highest doses achieving response...
The FDA issued a formal warning letter to Novo Nordisk, citing serious violations for failing to report adverse events such as strokes, suicidal ideation, and patient deaths linked to its GLP‑1 drugs Ozempic, Wegovy and Saxenda. Inspectors found the company...
Introducing "100 Questions and Answers About Artificial Intelligence in Healthcare" - your essential guide to understanding the integration of AI and medicine. - Explore 100 essential questions, each offering concise yet insightful answers supported by research and real-world examples. - From the...
Researchers published in Aging Cell report that vascular injury induces misshapen nuclei in smooth muscle cells, accelerating cellular senescence. Human femoral arteries post‑angioplasty and rat carotid injury models both displayed nuclear dysmorphism linked to prelamin A buildup. The study identifies...
Serenity Engage, now rebranded as Serenity Connect, is a HIPAA‑compliant communication platform that links senior living communities, healthcare providers, and families. The solution consolidates messaging, photo sharing, and real‑time updates into a single concierge‑style interface, often paired with voice‑AI assistants...
Researchers have identified that a surface‑defensive molecule on cancer cells not only sends a “don’t‑eat‑me” signal but also conceals an “eat‑me” cue that would normally trigger immune clearance. A newly engineered antibody can disrupt this masking interaction, making tumors visible...
Jillian Romeo’s experience shows how young adults with cancer often face dismissed symptoms until disease advances. A 2024 analysis found 87% of adolescents and young adults had documented warning signs before diagnosis, with females waiting over three months on average....
A new JACC: Cardiovascular Interventions study of over 10,000 PCI patients in Japan found that heart‑failure hospitalizations occur in 4.7% of cases and are linked to a 25% two‑year mortality rate. By contrast, acute coronary syndrome and major bleeding showed...
Stryker, a leading medical‑device maker, suffered a wiper attack that used Microsoft Intune to remotely erase data on thousands of phones and workstations. The Iran‑linked Handala group claimed responsibility, alleging the theft of 50 TB of data and the destruction of...
Boston Scientific announced that its Rezūm Water Vapour Therapy outperformed standard combination drug therapy in a 12‑month VAPEUR trial for symptomatic BPH in sexually active men. The study of 151 patients showed a 4.6‑point greater reduction in IPSS scores and...
A retrospective TriNetX analysis of 1,691 psoriasis patients compared bimekizumab with IL‑23 inhibitors and found no greater incidence of new‑onset depression, suicidal ideation, or related medication use. Over a two‑year follow‑up, the combined psychiatric event rate was 4.9% for bimekizumab...
Dr. Eric Dessner, an ophthalmologist, shares his year‑long, non‑surgical recovery from a large lumbar herniated disc. He describes the biological process of disc material dehydration and phagocytic resorption, the limited benefit of physical therapy and epidural injections, and the eventual...
The ONC’s HTI-5 rule, released Dec. 2025, proposes removing 34 of 60 EHR certification criteria and revising several others, while overhauling information‑blocking exceptions and scaling back AI model‑card transparency. Comment letters show broad support for the certification cleanup but fierce resistance...
After‑hours care remains a persistent gap in primary‑care delivery, with offices typically closed about 75 % of the day. The article argues that expanding capacity for both urgent and non‑urgent visits is essential to improve patient access without overloading clinicians. It...
Alvarez & Marsal’s MA Pulse Survey of 30 health‑system executives reveals a sharp inflection in Medicare Advantage participation, with declining reimbursements and rising denials eroding profitability. Six in ten respondents expect lower payments, while 74 % anticipate tougher collections and 52 % foresee...
A randomized, double‑blind study published in Mayo Clinic Proceedings found that a single 25 mg dose of off‑prescription Adderall caused significant acute increases in blood pressure and heart rate among healthy young adults. Systolic pressure rose by roughly 10 mm Hg, diastolic by...
The five‑year SOLVE‑TAVI trial shows that self‑expanding and balloon‑expandable transcatheter aortic valves deliver comparable long‑term efficacy and durability in both men and women with severe aortic stenosis. Stroke incidence was markedly lower in women receiving the self‑expanding valve (0.9% vs...
Actually yes. The placenta has been used in medicine for over 100 years. The amniotic membrane is used in eye surgery for corneal reconstruction. It's used as a graft for burn treatment and wound healing. It's used in dental and orthopedic...
FDA commissioner Makary at a CMS conference today in Baltimore calls for “big and different” IRB reforms to catch China's speedy trial starts - pre-IND phase can run 380 days in the US, he said, while China is pushing for...
Kent and Medway Mental Health NHS Trust has added three digital tools to its electronic patient record (EPR) to capture peer support outcomes, including the Hope, Agency and Opportunity (HAO) measure, a dedicated peer‑support tab, and a specific SNOMED activity...
Medical Research Is Hopelessly Caught in Red Tape. Part of the blame goes to "bioethics," which I've long argued is highly unethical. https://t.co/6tF016elEH
AI, strong on details, and tantalizingly close to curing cancer? Sobering to still see examples like these regularly.
NeoGenomics announced that its PanTracer™ LBx liquid biopsy test has received Medicare coverage under CMS’s MolDX program. The CLIA‑certified assay profiles more than 500 genes, including MSI and blood‑tumor mutational burden, with a seven‑day turnaround. Coverage allows Medicare beneficiaries to...
« @RadNetImaging CEO Howard Berger, MD, said it has become increasingly critical to #reengineer high-volume #workflows. This is particularly pertinent in X-ray, ultrasound and mammography, where @gleamer_ai holds expertise. » 👌 🚀 https://t.co/wSqNyHlkXj
CytomX surges on positive data for ‘masked’ ADC in colorectal cancer https://t.co/PxQMISvyri by @Lilah_Alvarado $CTMX + 66%
Modern electronic health records now contain years of notes, labs, imaging and messages, creating a “storage unit” that clinicians cannot fully review in the few minutes before a visit. This overload forces doctors to perform a real‑time “chart biopsy,” often...
Innovation with genAI, predicting insulin resistance from wearable device data (for steps, heart rate, sleep) integrated with demographics and routine blood parameters. Without CGM. @aametwally1 @GoogleResearch @NatureMedicine https://t.co/PRZPLGjuxZ https://t.co/ShbFyO55qP
Structure’s GLP-1 pill shows ‘best-in-class’ potential in obesity trial https://t.co/j0fzAg6GRV @ByJonGardner $GPCR $LLY $NVO $AZN $MRK #obesity
Six biotech firms are pushing next‑generation prostate‑cancer therapies through late‑stage trials and financing milestones. Candel Therapeutics secured a $100 million royalty deal to fund aglatimagene’s launch, while Coherus Oncology closed a $50.1 million offering and partnered with J&J for a CCR8 antibody...
CMS' CMMI dir. Abe Sutton at quality conf. in Baltimore today: "tying what we pay to what other countries pay across Medicare Part B, Medicare Part D and Medicaid really matters."
A polygenic risk score that predicts Type 2 diabetes, obesity, and likelihood for requiring a GLP-1 drug. Across 6 ancestries. https://t.co/5hTVv8kqlK https://t.co/IgXhx8vFA6
The U.S. still plays “Where’s Waldo?” with provider data. @HeyEpic ’s new concept paper lays out how CMS and partners can build a real-time, API-driven national directory. 🌐 https://t.co/URsJiyAhMm #Interoperability #FHIR #HealthIT #DigitalHealth #HITSM
The era of digital biology, exemplified by making a bespoke and effective vaccine for cancer in a dog, is taking off. Access to the AI-Coscientist. A new feature @NatureMedicine https://t.co/AR9lqne7E1
Last week at #HIMSS26, the Oracle Health and Life Sciences team showcased how AI can connect patients, providers, payers, and public health organizations. See what you missed and learn how our AI-powered tech can help your organization. https://t.co/JphBBwbFT2
