Medtech Insight - News And Expert Analysis For Medtech Decision Makers since 1975

The US FDA's clearance of QP-Prostate positions the company to support US health care providers and growing markets for fusion biopsy and focal therapy, said Quibim CEO and founder Angel Alberich-Bayarri.

The company is recalling Pipeline Vantage 021 and 027 models because they pose a higher than normal risk of failing to properly attach to blood vessel walls, which can cause thrombosis, stroke or death. The recall for 027 is a product removal and for 021 is an update to the instructions for use.

Industry likely wants Grace Graham to take the FDA’s top policy and legislative role, but she may be passed over for someone more tied to HHS Secretary Robert F. Kennedy Jr.’s interests.

The EHDS’ pivotal role in generating real-world evidence and capturing patient-reported outcomes will be a bonus for health technology assessment, especially in digital health.

Centralized decisions and cost savings are targeted in the UK government’s plan to combine much of NHS England with the Department of Health and Social Care. The action will likely divert resources away from health ministry efforts to launch the 10-Year Care Plan, but how else will medtechs be impacted?

Saudi Arabia’s proactive approach to health regulation prompted a lively debate among panelists at the Global Healthspan Summit 2025 in Riyadh.

Implementing a reflex test alongside traditional prostate cancer screening is cost-effective for high-risk groups, claims Prostate Cancer Research. Oxford BioDynamics sheds light on UK market conditions influencing the adoption of its reflex test, EpiSwitch PSE.

In this first of a two-part series highlighting digital and healthtech innovation in Barcelona, Medtech Insight visits the Barcelona Health Hub, a nonprofit that seeks to advance digital health innovation by bringing together start-ups, investors, health care institutions and corporations.

10XBeta is helping to develop a modular mobile health care platform as part of a federal initiative to improve the quality of care in rural areas. Company CEO Marcel Botha told Medtech Insight that the product fits the company’s goals of bringing treatment to the people who need it most.

The International Medical Device Regulators Forum discussed AI regulation, the development of a reliance playbook, and post-market regulation at the group's annual meeting in Tokyo last week. While the US FDA was not on-site, they were able to participate virtually.

Contactless health monitoring company Nuralogix has launched the new 4G connected Anura MagicMirror, which analyzes facial blood flow to provide health data, such as risk of heart attack, in real time.

ModMed unveiled its AI-powered ambient listening and clinical documentation software for orthopedic clinics at AAOS, ahead of its planned late-summer release. The health care software provider aims to create “the AI-powered practice” for specialty clinics to reduce clinicians' administrative burden and streamline clinical workflows.