International
Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.
This week, Hologic announced it would pay $350m for uterine fibroid treatment firm Gynesonics; the US FDA authorized a Novocure cancer treatment and a surgical robot from CMR Surgical; and the IMDRF announced 15 new members.
The medical device industry supports the FDA's draft guidance document on Diversity Action Plans but seeks flexibility and clarity, especially for international and IVD trials, and recommends using real-world data for postmarket studies.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
The ISRCTN clinical trials registry has launched an improved dashboard to provide metrics that reveal how many studies are complying with key transparency requirements. Badges are in place for individual studies meeting the transparency criteria.
Patient centricity, diversity, innovation and transparency are key topics in the World Health Organization’s new guidance that recommends best practices for clinical trials and complements existing international guidance in this area.
Philip Morris described a scenario of being essentially blacklisted by the health care sector and its CDMO partners as it threw in the towel on its £1.1bn acquisition of UK inhalation specialist Vectura. It agreed to offload the firm at a fraction of the initial cost.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Nearly 80 documents have been posted on the tracker since its last update.
In this episode, Medtech Insight senior reporter Hannah Daniel speaks to DJ Fang, chief operating officer and co-founder of Pure Global. Pure Global uses AI to help device manufacturers navigate global regulations, and we talk about clinical trials, how countries incentivize medtech innovation, and the Biden Administration’s tariffs on some Chinese-made medical devices.
Medical device regulatory reliance and recognition of third-party regulators’ approvals have been making news in the UK, but in certain other markets the practice is well established. International regulatory experts explained their experiences at the MedTech Forum 2024.
The Medical Devices Information System (MeDevIS) platform, launched by the WHO this week, consolidates information on 2,301 device types and streamlines device nomenclature to support informed decision-making by governments, regulators, payers, and healthcare providers.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
When looking for a standard for AI development, expert Eric Henry recommends turning to the tried-and-true Standard Delivery Organizations (SDOs).
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-five documents have been posted on the tracker since its last update.
The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.
A survey of over 1,000 patients worldwide found that the majority of patients agree that hospitals and endoscopists are responsible for mistakes made by devices that use AI.
Masimo receives US regulatory clearance for Stork OTC baby monitoring system six months after Owlet received first clearance for its Dream Sock following a regulatory stumble which halted sales of a previous device, Smart Sock, in 2021.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.