Geography

The US FDA says Olympus has updated its instructions for a device used in many endoscopic procedures after reports of serious injuries. The class I recall follows the FDA blocking imports of other scoping devices from the Japanese firm earlier this year.

India is transforming its medtech sector from a consumer-importer market into an innovator-exporter industry. But stakeholders are aware of a public-private investment imbalance, In Vivo notes in part three of its APACMed 2025 conference report.

The top awards at the annual MedTech Innovator APAC are handed out to an increasingly varied range of products and applications, and the class of 2025 was no exception in its reflection of healthtech’s ever-widening innovator base.

Two recent warning letters from the US FDA provide the companies with 30 business days to respond instead of the usual 15. Though not a regulatory requirement, the 15-day time frame has become the standard.

A new face seconded to the European Commission's medtech unit and changes to several EU rules impacting medtech

Aerogen, which is Ireland’s largest native medical technology firm, is in clinical trials for Aerofact, a nebulizer aimed at aiding premature infants' breathing. The technology promises easier administration of surfactant, with potential commercial rollout projected in three to four years, if succes

Sponsors of higher risk device and diagnostic investigations are being invited to participate in a pilot that aims to reduce regulatory burden.

Start-up medtech firms in the west of Ireland can benefit from incubator programs at two of the region’s universities, which support innovators across the medical device and digital health industries from concept to multi-employee businesses.

The rise and fall of US tariffs and the chill headwind from China’s state procurement policies have blown onto medtech’s radar. But how to monetize AI is the dominant concern up and down the industry.

Google Cloud healthcare lead Shweta Maniar talked with Medtech Insight about improving health monitoring, boosting regulatory collaboration, and deepening integration of technology in medical practices.

The US Department of Commerce’s investigation into the national security impact of importing various medical equipment could lead to tariffs on many products. Device industry responds by emphasizing the robustness of domestic production, but also the rigidity of supply and reimbursement agreements.

Clinical evaluation and standards expert Danielle Giroud celebrates progress on the document and looks at what it means internationally and for the EU.

The US Department of Commerce’s investigation into the national security impact of importing various medical equipment could lead to tariffs on many products. Device industry responds by emphasizing the robustness of domestic production, but also the rigidity of supply and reimbursement agreements.

Brazil is planning to update its National Clinical Research Action Plan to make the country a more competitive location to conduct R&D.

Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

During a webinar hosted by Sedgwick, a pair of regulatory experts discussed how medtech firms can optimize their engagement with the FDA, especially when it comes to communicating recalls and corrective actions.

The US FDA has approved Flow Neuroscience’s at-home brain stimulation device for the treatment of depression, ending a frustrating wait for the Swedish firm.

The US FDA’s General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee convened Wednesday to discuss germicidal ultraviolet (GUV) devices as a mode of disinfection, a technology that has emerged since the COVID-19 pandemic.

Freenome will combine with Perceptive Capital Solutions Corp in a SPAC deal worth $330m. The goal is to advance Freenome’s blood-based tests for early detection of cancer and, in 2026, launch its advanced colorectal cancer detection test SimpleScreen, currently under FDA review.