Device firms back latest MDUFA deal, while patients want more postmarket safety
The latest agreement includes higher fees for overseas firms, hiring transparency requirements and greater use of real-world evidence.
The latest agreement includes higher fees for overseas firms, hiring transparency requirements and greater use of real-world evidence.
Acquiring VitalConnect could unlock a $1 billion cardiac monitoring market that is only partly served by iRhythm’s existing devices.
NYU Langone Health and Dana-Farber Cancer Institute built an oncology decision support tool to guide clinicians through treatment. Now, the institutions are commercializing the product so other health systems can use it too.
By Sanjay Subramanian - Some of the most expensive work in healthcare is the work no one counts as care. Physicians and their teams chase authorization status, resubmit records, clarify denial reasons, and explain coverage confusion to patients. The post Stopping Avoidable Work: …
AI is helping development teams produce far more code, far faster. But security teams still have to review vulnerabilities, manage dependencies, prioritize fixes, and control risk at human speed. When software output jumps 10 to 50 times, the problem is no longer just finding vu…
OpenAI has announced that it's pausing some "internal activities" involving its upcoming artificial intelligence (AI) model Astra after an internal evaluation found it had made significant advancements in agentic coding and cybersecurity. In response to the discovery, the AI ups…
The CereCore Podcast release: On this episode of The CereCore Podcast, host Phil Sobol welcomes back Lynn Falcone, CEO of Cuero Regional Hospital, and Ismelda Garza, CIO of Cuero Regional Hospital and CereCore manager, for a candid conversation about their multi-year effort to im…
By Amy Oliver - I have always cared about healthcare access and equity. But recently it stopped being just a professional conviction and became something messier and more specific, the kind of care that comes from watching the system fail someone you love and not being able to do…
Health IT product news from 1upHealth, Cantata Health, CareHive Health, Caris Life Sciences, Carta Healthcare, MedeAnalytics, Trice Workspace, Teladoc Health, AGS Health, HOPPR, Luma Health, MDaudit, Pacific AI, Relatient, Revecore, SimplePractice, & Talkdesk. The post Health IT …
Privacy + Security Forum Fall Academy Davis Wright Tremaine
SS Support Network Expands U.S. Reach with Comprehensive BPO Services for Healthcare Providers voiceofalexandria.com
Outside experts will convene in September to review Grail’s premarket approval application for the MCED blood test. Experts selected for the committee will be key to watch, an analyst said.
By Kamya Elawadhi - When did "we believe we reached physicians" become an acceptable standard for a billion-dollar industry? Somewhere along the way, pharma marketing made peace with probabilistic targeting, inferred identities, and impression counts that looked impressive but pr…
By employing wearable devices to support patient monitoring between the hospital and home, Philips hopes to improve care continuity.
Open Source had a great childhood. For two decades it got to be a kid. It ran around barefoot, gave everything away, trusted strangers, and never once thought about who was watching. It ran the kind of lemonade stand that took IOUs from anyone who wandered up — take what you nee…
OpenAI is rolling out a more reliable version of ChatGPT GPT-5.6 Sol for Plus and Pro users, while Free users are getting unlimited text chats with GPT-5.6 Luna. [...]
Former chief security officers of the Democratic National Committee explain that a strong security-first mindset requires executive support – and a dose of absurdity.
NOW on Demand Tell Me Where IT Hurts episode with host Dr. Jay Anders and his guest Anna Dover, PharmD, Senior Director of Editorial Content at First Databank (FDB). Together they unpack pharmacogenomics, using a patient's genetic profile to predict which drugs will work and whic…
Business and financial news from SpinSci, CliniComp, Gr4vy, Wizlo, CharmHealth, Telemynd, RevealDx, Buzz Health, Wolters Kluwer Health, Wildflower Health, Cardinal Health, H1, Novo Nordisk, WHOOP and more. The post Health IT Business News, Financial Edition – August 6, 2026 appea…
The restructuring, intended to give Zimmer Biomet a fully dedicated sales force, is expected to be complete by the end of 2027.