jueves, 1 de enero de 2026

Learn to navigate regulatory pathways for SaMD

https://www.news-medical.net/whitepaper/20251210/Learn-to-navigate-regulatory-pathways-for-SaMD.aspx

Developments in EU MedTech legislation

https://www.news-medical.net/whitepaper/20251217/Developments-in-EU-medtech-legislation.aspx The EU continues to publish new legislation on various topics with the potential to affect medical devices and IVDs. These new laws often include long and complex transition periods covering several years. This article will go over some of the new and evolving legislation that manufacturers must understand to ensure future compliance.

Medical devices and EU laws

https://www.news-medical.net/whitepaper/20251217/Medical-devices-and-EU-laws.aspx This article takes a closer look at the multi-legislative compliance process for medical devices and in-vitro diagnostic medical devices (IVDs). Expanding on what was discussed in the first installment about product safety legislation and horizontal legislation, this article will focus on what manufacturers must do to comply with sectorial, horizontal, and national regulations.

Exploring geopolitical implications for MedTech

https://www.news-medical.net/whitepaper/20251218/Exploring-geopolitical-implications-for-medtech.aspx This article explores Europe, the EU, and the EU single market. The objective is to provide manufacturers with deeper insight into European countries and territories where CE marking enables market access.

The CE mark and market access

https://www.news-medical.net/whitepaper/20251218/The-CE-mark-and-market-access.aspx

Why AI is a game-changer for faster, more targeted influenza vaccines

https://www.news-medical.net/whitepaper/20251223/Why-AI-is-a-game-changer-for-faster-more-targeted-influenza-vaccines.aspx

Simple reminder emails increase clinicians' use of database for safe opioid prescribing

https://www.news-medical.net/news/20251230/Simple-reminder-emails-increase-clinicians-use-of-database-for-safe-opioid-prescribing.aspx

Private equity firms increasingly dominate fertility clinics in the United States

https://www.news-medical.net/news/20251230/Private-equity-firms-increasingly-dominate-fertility-clinics-in-the-United-States.aspx

Artificial intelligence unlocks new frontiers in RNA drug design

https://www.news-medical.net/news/20251231/Artificial-intelligence-unlocks-new-frontiers-in-RNA-drug-design.aspx

AI is transforming the economy — understanding its impact requires both data and imagination

AI is transforming the economy — understanding its impact requires both data and imagination Controlled studies capture only a fraction of the effects of artificial intelligence. Economists should work with social scientists to find innovative ways to fully grasp this fast-moving field. By Daniel Björkegren https://www.nature.com/articles/d41586-025-04053-w?utm_source=Live+Audience&utm_campaign=b220bf51eb-nature-briefing-daily-20260101&utm_medium=email&utm_term=0_-33f35e09ea-50432164

NIH begins review of thousands of delayed research proposals, funding 135 on first day Deal on DEI-related grants called a ‘win for researchers,’ but decisions are subject to political oversight

https://www.statnews.com/2025/12/30/nih-grant-delays-new-review-no-guarantee-approval/ By Anil OzaDec. 30, 2025 General Assignment Reporter

With the Wegovy pill, Novo Nordisk undercuts Eli Lilly in direct-to-consumer market Patients using insurance may not see savings with Novo’s pricing strategy

https://www.statnews.com/2025/12/29/wegovy-pill-price-novo-nordisk-strategy-weight-loss-drugs/ By Elaine ChenDec. 29, 2025 Elaine Chen, a national biotech reporter, is the co-author of The Readout, a newsletter about the business, science, and politics of biotech.

The most-read First Opinion essays of 2025 The wellness industry and animals, the biotech workforce, threats to vaccines — and more

https://www.statnews.com/2025/12/31/first-opinion-stat-most-read-2025/ By Torie BoschDec. 31, 2025 Editor, First Opinion

Why I’m skipping Dry January As a public health scientist, I weighed the evidence

https://www.statnews.com/2026/01/01/dry-january-moderate-drinking-research/ By Robert M. KaplanJan. 1, 2026 Kaplan is a senior scholar at the Stanford School of Medicine’s Clinical Excellence Research Center.

NIH director says DEI-related grants that were restored under a court order won’t be renewed ‘We won’t renew them’ in 2026, Jay Bhattacharya tells a podcaster

https://www.statnews.com/2025/12/31/nih-grants-director-jay-bhattacharya-says-restored-dei-funding-will-not-be-renewed/ By Anil OzaDec. 31, 2025 General Assignment Reporter

Drug Trials Snapshots: VIZZ - VIZZ (aceclidine ophthalmic solution)

https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-vizz VIZZ is for the treatment of presbyopia in adults. Presbyopia is a common age-related condition that affects the eyes’ ability to focus on near objects. As people age, the lens of the eye becomes less flexible, making it difficult to accommodate for close vision.

Drug Trials Snapshots: LYNKUET - LYNKUET (elinzanetant)

https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-lynkuet LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms or VMS) due to menopause.

Quality of Life, Survival, and Ethics: Lessons From CodeBreaK 300 in KRAS G12C CRC David Kerr, MD, DSc December 31, 2025

https://www.medscape.com/viewarticle/quality-life-survival-and-ethics-lessons-codebreak-300-kras-2025a10010fl

Court Allows Trump-backed Cuts to Planned Parenthood's Medicaid Funding in 22 States Nate Raymond December 30, 2025

https://www.medscape.com/s/viewarticle/court-allows-trump-backed-cuts-planned-parenthoods-medicaid-2025a10010r7

Should The FDA Require “Clinical Licensure” of AI Tools For Doctors? Carrie Arnold December 31, 2025

https://www.medscape.com/viewarticle/should-fda-require-clinical-licensure-ai-tools-doctors-2025a10010t1