North America
Royal Philips has taken a “significant step” in advancing live-data analytics in clinical practice in a new collaboration with US Mass General Brigham. The parties will leverage software platforms to unify EMR, lab and bedside medical devices data.
Foster, an advisor to the HHS Assistant Secretary for Preparedness and Response during the COVID-19 pandemic and counsel to the Senate HELP Committee, also served in various legal roles at small biotech companies. He replaces agency veteran Mark Raza.
Anita Jackson is facing 25 years for device adulteration and a host of other charges. She says the trial and appeals court failed to consider her defense.
Hologic attains full US Food and Drug Administration 510(k) clearance for its Aptima SARS-CoV-2 assay, which reached market under an Emergency Use Authorization (EUA). Overall, Hologic’s “best-performing” molecular diagnostic business continues to grow despite the decline in revenue for COVID-19 assays and related items.
Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.
Medical device recalls exceeded 1,000 in 2024, according to a recently published recall index report from Sedgwick. More than 10% of those recalls were class I, the FDA’s most serious category.
The 12 initial awards, which total almost $100m, are part of an ongoing program to develop a high-tech mobile hospital that can reach patients with limited access to health care.
France-based Germitec aims to double its yearly revenue by expanding its UV-C disinfection technology for endocavitary ultrasound probes into the US market.
Volta Medical’s TAILORED-AF clinical trial demonstrates that AI can achieve "superior efficacy" in interventional cardiology. The study examined the use of AI-driven Volta AF-Xplorer in addition to pulmonary vein isolation in treating patient with persistent atrial fibrillation.
A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”
For the fourth time in as many years the FDA has issued a communication concerning a key accessory from Olympus used in several types of urological procedures. This time, however, the agency has added a class I recall confirmation to its original early alert on the device issued in December 2024. A device safety specialist provided Medtech Insight with a deeper understanding of the problem as well as overall scope safety.
The US FDA says in a legal memo that its new guidance on scientific information on unapproved uses (SIUU) is “speech-enabling” and argues that challenges should be interpreted as attempts to roll back the approval process.
Glucotrack is a step closer to marketing its implantable continuous blood glucose monitor, which met primary safety endpoints in its first human trial and is pitched as a potential alternative to existing CGM systems.
Oxford BioDynamics' blood-based colorectal cancer diagnostic test EpiSwitch NST has shown high accuracy (81-85%) and positive predictive values (57-87%) for colorectal cancer and polyps. By reducing false positives, the test could minimize unnecessary follow-up procedures.
President Trump’s 10% tariff on active pharmaceutical ingredients and finished dosage forms could push some generic drug makers to exit therapeutic categories if they cannot absorb the new costs, which could lead to shortages.
The sudden halt to grants and health agency communications is causing stress for the rare disease advocacy community, speakers said at a recent rare disease symposium.
While communications from the FDA have been scant since the presidential transition, early alerts from the agency’s device center are flowing again. The most recent alert includes an issue with numerous injuries and four deaths associated with a device used during cardiac procedures.
Precision medicine startup LinusBio launches its breakthrough diagnostic aid across 44 US states. The laboratory test aims to support earlier diagnosis of autism spectrum disorder and can be ordered by health care providers.
The US Food and Drug Administration (FDA) draft guidance limits tissue biopsy collection in clinical trials to primary endpoints and specific research use cases. However, Andrew Newland, CEO of circulating tumor cell (CTC) liquid biopsy firm Angle Plc, believes that the guidance could enhance the market for liquid biopsy makers.
The FDA's recent communication freeze has blocked participation in international standards development groups. The agency's absence could impact the alignment of US and international standards, potentially affecting medical device manufacturers' ability to sell products globally.