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.

The just published proposed targeted revision of the Medical Device and IVD Regulations is a radical rethink of how the EU should regulate medical devices. The document is aimed at supporting industry and patients alike.

Roadmap version 1.0 is a living document, not a legislative instrument, that will be updated and tweaked for timings as necessary.

New document sets out a structured framework to help breakthrough medical devices tackling serious health needs navigate EU regulation with greater clarity, collaboration and predictability.

Just ahead of the European Commission publishing its proposed revisions of the Medical Device and IVD Regulations, it has released an equally important document on the future of notified body operations in the bloc.

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.

As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.

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.