Geography

NextGate Partner’s Jay Byun gives a mixed review of South Korea’s recent biopharma policy measures, saying providing government support to all cycles of R&D may lower efficiency.

AdvaMed welcomed the Supreme Court’s recent decision to strike down the Trump administration’s policy on imposing tariffs on US trade partners, though the trade group doesn’t see the tariff issue going away.

The US FDA has published its annual international harmonization assessment for fiscal 2025, which reports on the device center’s progress in aligning medical device regulations with global standards to improve patient access to safe, innovative technologies.

The timing of the US tariff reset is also notable. It comes days after India and the European Union concluded a trade deal under which duties on medical devices will be cut from 27% to zero, while allowing liberalized tariffs for devices made in India.

In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.

Numares Health bets on a metabolomics-based urine test to help doctors detect kidney transplantation rejection earlier than current biomarkers, which would allow doctors to intervene earlier in trying to save the transplanted organ.

Certain short-term EU market improvement measures are expected to be in place this month, said the European Commission, which has challenged device industry stakeholders for input and advice as the EU’s late-2025 bundle of device regulatory improvements begins to take shape.

The public consultation on the European Commission’s proposed revision of the MDR and IVDR has been extended to accommodate late delivery of translated texts. EU notified bodies’ group TEAM-NB says the proposals need more balance to ensure the resulting regulations do not do more harm than good.

IMDRF’s playbook on regulatory reliance was in the spotlight at the Forum’s 29th meeting this week, on the heels of its new midterm regulatory strategy document. 2026 IMDRF chair Singapore used the occasion to announce unprecedented WHO acclaim for the nation’s device regulatory oversight.

Surgeon burnout is not a new phenomenon, but where it once was episodic, surgeons now report that it feels more sustained. Support structures have not kept pace, said Johnson & Johnson MedTech VP Africa Wallace on the release of a new study of causes, trends and issues arising.

AdvaMed welcomed the Supreme Court’s recent decision to strike down the Trump administration’s policy on imposing tariffs on US trade partners, though the trade group doesn’t see the tariff issue going away.

The US Supreme Court struck a blow to the Trump administration’s efforts to impose sweeping tariffs, ruling the president exceeded his authority. Limiting tariffs has been a priority for the medtech industry.

The US Supreme Court struck a blow to the Trump administration’s efforts to impose sweeping tariffs, ruling the president exceeded his authority. Limiting tariffs has been a priority for the medtech industry.

The US FDA has published an updated inspections manual detailing how it will conduct investigations going forward under its new regulatory framework. Medtech Insight talked to a couple of regulatory experts about the key changes to the new protocol.

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.

During an ECRI-hosted webinar on AI-enabled diagnostics, a panel of experts discussed the promise and risks that come with the technology for both physicians and patients alike.

The US Congress overwhelmingly passed legislation reauthorizing federal programs essential to smaller medtech firms in need of funding. AdvaMed says the bill is critical for medtech innovation.

The FDA approved JenaValve’s Trilogy HeartValve for treating severe aortic regurgitation, marking it as the first TAVR device for this condition in the US. The approval, which followed promising clinical results, is significant for patients with limited options due to high surgical risks.

The US FDA has issued an early alert concerning Intuitive Surgical staplers used during various procedures with the da Vinci Surgical System. The company is instructing customers to stop using the devices.