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