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
Natus Medical has launched autoSCORE™, the first AI model that delivers comprehensive clinical EEG interpretations with accuracy comparable to top neurologists. The deep‑learning tool, trained on 30,000 expertly labeled recordings, received FDA 510(k) clearance for routine, long‑term monitoring and ambulatory EEG studies and holds a CE mark for global markets. Introduced in the U.S. in August 2024, autoSCORE integrates into Natus NeuroWorks software, offering study‑level normal or abnormal assessments beyond traditional spike detection. Early adopters say the system eases staffing pressures and accelerates diagnostic decisions.
Non‑emergency medical transportation (NEMT) is essential for dialysis patients, whose weekly treatments depend on reliable rides. Missed appointments can trigger fluid overload, electrolyte imbalance, and even cardiac arrest, turning a simple no‑show into a medical emergency. NEMT providers act as...
New research published in The Journal of Clinical Endocrinology and Metabolism finds that higher fasting insulin levels in women’s late 40s predict earlier onset and longer duration of hot flashes and night sweats. The study shows insulin is a stronger...
Eli Lilly announced that the CMS CMMI BALANCE Model will cover its GLP‑1 obesity drugs—Zepbound, Mounjaro and, if approved, orforglipron—under Medicare Part D starting Jan 1 2027. After meeting the deductible, beneficiaries will pay a $50 monthly out‑of‑pocket cap, while pre‑deductible cost sharing is...
RBMA warned that upcoming federal Medicaid cuts could strip millions of coverage, especially in rural areas where balanced‑budget rules force states to trim enrollment or provider payments. The Congressional Budget Office projects 11.8 million loss of insurance, heightening financial strain on...
Walgreens has launched a $49 per‑visit weight‑management program within its Virtual Healthcare platform, offering clinician‑guided GLP‑1 prescriptions for adults 18‑64. Patients complete an online video consult, after which licensed doctors or nurse practitioners can prescribe FDA‑approved drugs such as Wegovy....
Ric Sinclair will assume the role of chief executive officer at Cotiviti on March 16, 2026, succeeding Dr. Emad Rizk, who moves into a senior‑advisor capacity after a decade of steering organic growth and major acquisitions. Sinclair arrives from Waystar,...
Xenon Pharmaceuticals reported that its Phase 3 X‑TOLE2 trial of azetukalner, a novel Kv7 potassium channel opener, achieved a 53.2% reduction in focal onset seizures at the 25 mg dose, far exceeding expectations and representing the highest placebo‑adjusted efficacy recorded in a...
Pittsburgh EMS launched the Rescue Medicine Bundle, an aggressive pre‑hospital care program that treats shock, hemorrhage, hypothermia and pain during extrication. From 2022‑2025 the bureau completed 118 rescues with 116 survivors, and in 2025 alone achieved a perfect 100 % survival...
Axena Health announced that its Leva Pelvic Health System achieved clinically meaningful improvements in fecal incontinence symptoms among women, according to a real‑world evidence study published in Diseases of the Colon & Rectum. The study demonstrated statistically significant reductions in...
Cloudcure has introduced a companion weight‑management app that serves as a clinical anchor for patients using GLP‑1 therapies in Canada. The platform blends clinician‑led messaging, evidence‑based behavioral curricula, and real‑time medication titration to address the adherence gap created by transactional...
Moon Rabbit’s managing director Jimmy Driscoll and VP Aimee Turner discussed their agency’s intimacy philosophy and how it shapes media integration in healthcare marketing. They highlighted the need to design personal, human‑centric moments amid a fragmented media environment. The conversation...
Dental implants serve 3.5 million Americans annually, yet average prices near $4,000 per unit keep many patients from treatment. Innovations such as mini‑implants, All‑on‑4 overdentures, and digital surgical planning are reshaping affordability by cutting material and procedural costs. However, pricing still...
GE HealthCare has secured FDA 510(k) clearance for View, a zero‑footprint, cloud‑native diagnostic viewer that anchors its Genesis Radiology Workspace. Radiologists currently spend up to 44% of their time on non‑interpretive tasks, a bottleneck View aims to eliminate by removing...
The Associated Press published a story alleging that FDA senior regulator Dr. Tracy Hoeg was pushing a petition from Dr. Adam Urato to add pregnancy‑risk warnings to antidepressants and that their personal relationship constituted a conflict of interest. The author,...
Amazon Pharmacy has launched Eli Lilly’s Zepbound KwikPen, a multi‑dose GLP‑1 weight‑loss injector, on its platform with a self‑pay price of $299 per month. The KwikPen delivers a full month’s dose in a single pen, cutting waste and easing patient...
Retinal imaging is transitioning from a niche eye‑disease tool to a non‑invasive platform for systemic health assessment. Recent studies show that microvascular patterns in the retina can predict cardiovascular events, diabetes, kidney disease, and even early cognitive decline. AI‑driven analysis...
Tacit Therapeutics, an RNA‑editing startup focused on neurological disorders, announced its launch backed by a $19 million financing round. The capital, led by Andreessen Horowitz and DCVC, will fund the development of ADAR‑based therapeutics targeting diseases such as ALS, Huntington’s, and...
RFiD Discovery has introduced an automated contact‑tracing solution for hospitals that leverages Bluetooth Low Energy (BLE) wristbands for patients and BLE‑enabled ID badges for staff. The system captures proximity, duration, distance and location data in real time, feeding it into...
A cross‑sectional analysis of 26,805 cardiologists found that industry payments averaging $3,958 are linked to higher Medicare spending, with each $10,000 increase in payments associated with a $14.1 rise in per‑beneficiary costs. The relationship held after adjusting for physician and...
Only three of north‑central Florida’s 14 counties have full obstetric coverage, while five are maternity‑care deserts affecting roughly 3,400 women of child‑bearing age. Hospital closures have left 18 of the state’s 21 rural hospitals without obstetric services. In response, the...
Universal Health Services (UHS) announced an $835 million acquisition of virtual behavioral‑health platform Talkspace at $5.25 per share, a 10% premium. The deal brings roughly 6,000 clinicians into UHS’s network, addressing chronic staffing shortages that have limited growth in its behavioral‑health...
The FDA’s Oncologic Drugs Advisory Committee will convene on April 30 to evaluate AstraZeneca’s oral SERD camizestrant for first‑line HR‑positive, HER2‑negative breast cancer and its AKT inhibitor Truqap for metastatic hormone‑sensitive prostate cancer. Camizestrant’s Phase 3 SERENA‑6 trial reported a 56% reduction...
Prime Minister Narendra Modi highlighted healthcare, education and tourism as pillars for a developed India, urging reforms and stakeholder collaboration. He stressed expanding telemedicine and training youth for the burgeoning "care economy," which could employ 60 million people and generate a...
Seattle’s fire department relies on for‑profit contractor American Medical Response (AMR) for most 911 transports and introduced a Nurse Navigation program in 2022 to triage low‑acuity calls via a remote nurse line. The program exempts nurse‑ordered ambulance rides from standard...
Oregon Senate Bill 1575 aims to stop hospice fraud by barring operators with prior misconduct from opening in the state. The bill imposes a temporary moratorium on new hospice licenses while licensing rules are revised. It requires the Oregon Health...
The FDA rejected Incyte’s supplemental application to add non‑small cell lung cancer to Zynyz’s label, citing compliance failures at Novo Nordisk’s Catalent‑owned Indiana manufacturing plant. The agency’s complete response letter pinpointed inspection findings at the site as the sole approvability...
The NHS is mislabeling its core challenge as a productivity deficit when the real issue is a lack of precision in deploying clinical expertise. Clinicians spend a disproportionate amount of time on administrative tasks, poor workflows, and unnecessary referrals, eroding...
Amgen’s Lumakras earned accelerated FDA approval in 2021 as the first KRAS‑targeted therapy, but sales have been modest, reaching $92 million in Q4 2025 with only an 8% year‑over‑year increase. A second G12C inhibitor, Krazati, entered the market in 2022, narrowing Amgen’s...
Steriline has delivered its OFCM84 aseptic filling and capping line to Bausch+Lomb Italia to boost eye‑care product output. The line runs at 200 bottles per minute, features CIP/SIP automation, and complies with EU GMP Annex 1 grade‑A cleanroom requirements. Its design...
The Healthcare Justice Coalition, representing the liquidation trusts of two bankrupt physician‑staffing firms, has filed an antitrust lawsuit against the Blue Cross Blue Shield Association and its 33 carriers, alleging coordinated actions that inflate provider costs. The complaint seeks an...
The GAO analyzed 2024 NAIC enrollment data and found that private stand‑alone dental and vision insurance markets are highly concentrated, with the three largest insurers capturing 38‑98% of dental and 41‑96% of vision group market enrollment across states. Median market...
Health Secretary Robert F. Kennedy Jr. announced plans to direct the FDA to move roughly 14 previously banned peptides from the agency’s category 2 list to category 1, allowing pharmacy compounding and physician prescribing. The change would reverse a 2024 ban on...
Johns Hopkins’ Artificial Intelligence and Technology Collaboratory for Aging Research (JH AITC) has distributed $20 million in National Institute on Aging funds to 45 states, D.C., Puerto Rico and the U.S. Virgin Islands, spawning 42 peer‑reviewed papers, seven market‑ready products and $11.7 million...
Roche’s oral SERD giredestrant failed to meet its primary endpoint in the phase 3 persevERA trial, showing no significant improvement over letrozole when combined with palbociclib in first‑line HR‑positive, HER2‑negative advanced breast cancer. The company now limits U.S. filing to ESR1‑mutated...
New research tracking 12.4 million newborns shows the hepatitis B birth‑dose vaccination rate dropping from 83.5 % in 2023 to 73.2 % by mid‑2025, meaning roughly 400,000 infants each year are refusing or delaying the shot. The decline coincides with the CDC’s January decision...
At HIMSS26 Epic unveiled Agent Factory, a no‑code, drag‑and‑drop AI builder that lets health systems create and orchestrate autonomous agents across clinical and operational workflows. The move follows Epic’s dominant market position—42.3% of acute‑care hospitals and 54.9% of beds in...
Researchers have integrated an electric field into electrohydrodynamic (EHD) bioprinting to orient fibrin‑alginate hydrogels, producing nanofiber alignment that directs myocyte organization. The conductive polymer‑enhanced constructs exhibit improved myotube differentiation and mimic native muscle conductivity. In vivo tests on rats demonstrated...
Researchers have engineered a recyclable magnetic nanosystem (Fe3O4/CeO2@BP) that integrates black phosphorus with iron oxide and cerium oxide to achieve rapid, ROS‑driven antibacterial activity in blood. The material can be magnetically retrieved, enabling repeated use across at least 20 disinfection...
LifeVac has secured FDA De Novo classification, designating its suction anti‑choking device as a Class II medical device for second‑line treatment after failed basic life support protocols. The clearance confirms the device as a single‑use, non‑powered, non‑invasive tool suitable for adults and...
Smartphone-connected ultrasound devices could bring an interesting new layer to spinal diagnostics. A system like SpineUs combines a handheld ultrasound scanner with tracking software and AI-based reconstruction to create 3D visualizations of the spine’s surface in near real time. According to Verdure...
Not just replication, but triplication of the benefit of revving up cancer immunotherapy with FMT (Yes💩) https://t.co/rXyQdO74FJ
Aisa Pharma announced positive Phase II data for AISA‑021, a once‑daily calcium channel blocker, in systemic sclerosis‑associated Raynaud’s phenomenon (SSc RP). The double‑blind, placebo‑controlled RECONNOITER trial enrolled 64 patients and showed a 22.1% reduction in weekly Raynaud attacks and a 155% placebo‑adjusted...
Two terrific #FDA related pieces by @lizzylawrence.bsky.social & @matthewherper.bsky.social. Matt's is a look at lessons to be drawn from Vinay Prasad's chaotic tenure; Lizzy's delves into the FDA's turning away from adcomms. https://t.co/gC5GNTiPm1 & https://t.co/ygvylHi0uz
. @matthewherper is so damn reasonable. Smart, too. 5 lessons from Vinay Prasad’s turbulent tenure at the FDA https://t.co/R65vPj5ep5
AOK Bayern, one of Germany’s largest statutory health insurers serving 4.5 million members, has migrated its contact‑center operations to NICE CXone on the EU Sovereign Cloud. The move replaces legacy on‑premises systems with a unified, cloud‑native platform that integrates voice, chat, email...
The #VRBPAC committee is scheduled to meet Thursday to advise #FDA on #flu vaccine strain selection. VRBPAC is supposed to have at least 15 members. It currently has 7 voting members & no chair. It has met only twice since...
The cost of failure in #healthcare makes this conversation urgent. Psychological safety, rapid escalation pathways, and empowered frontline teams are just as important as analytics tools. #AI #Risk https://t.co/idxNhb1kRE
Researchers at Washington University have created a blood‑test model using plasma p‑tau217 that can predict the onset of Alzheimer’s symptoms within three to four years. The model, validated on 603 participants, shows age‑dependent timelines, with younger individuals experiencing longer asymptomatic...
The $RLMD bladder cancer data (phase 2) reported this morning look very good. Another competitive blow to $IBRX particularly at its bloated valuation. https://t.co/wYThfwIpG8
