Geography

The FDA’s final guidance on PCCPs for AI-driven devices highlights rapid advancements in health care AI, providing a roadmap for future progress. It emphasizes iterative improvements, version control, and maintaining device safety and effectiveness.

During an online seminar Tuesday, the FDA offered guidance on registration and listing requirements for lab-developed tests that will go into effect on 6 May 2026.

The agency also will not expand the guidance categories that may be issued “for immediate implementation” without prior public comment, but more guidance documents could be issued in Q&A or bulleted formats, the agency said.

A recent pilot program from public-private partnership MDIC attempted to apply the FDA’s established Voluntary Improvement Program framework to manufacturers with known compliance issues. Participants found an improved mindset, a better relationship with the FDA, and conclusions to ongoing enforcement actions.

El Salvador has approved a new law that will establish a new regulatory body responsible for authorizing medicines and setting prices.

This week, Quidel recalled the Triage cardiac panel due to a risk of false results; Teladoc and Lifebit announced new partnerships; and, a court upheld a false advertising verdict against Natera, but struck the financial penalties.

This week, North Carolina health secretary Mandy Cohen was named the new head of the CDC; Congress debated PAHPA reauthorization; Cala Health launched a Parkinson’s Disease wearable; and IHealth.io was fined for consumer privacy violations.

The US FDA says it’s “investigating certain imported medical gloves that appear to have been reprocessed, cleaned, or recycled and sold as new.” The 270 firms in question are listed on an import alert that says their gloves are subject to Detention without Physical Examination.

Incoming EU health commissioner gets to grips with need for MDR review and faces demands from council ministers for centralized elements in EU devices legislation.

As the consultation period draws to a close for the UK’s new inclusion and diversity guidance, researchers and sponsors are being invited to participate in a pilot next year to submit a diversity plan as part of their clinical trial application.

After raising $68m series B funding in September, Neo Medical's announced on 2 December that its entire product portfolio has secured EU MDR approval. Co-CEO and founder Vincent Lefauconnier explained the rationale to Medtech Insight.

We do not want the commission to wait for its targeted evaluation before making regulatory changes to the MDR and IVDR, medtech industry representatives tell Galway meeting. They shared their vision of what could happen next.

The head of the Korea Regulatory Science Center discusses why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

After high-level deliberations, a draft Medical Device Administration Law to supersede the series of medical devices administrative orders has been issued by the Chinese State Food and Drug Administration. A stakeholder consultation is underway.

The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

Medical device manufacturers are among the companies that will face more regulatory challenges in the coming year. Two new reports look at the growing complexity of the regulatory landscape organizations will have to navigate.

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

European cross-country HTA collaborations have much to learn from each other to keep prices from rising unfairly, Nordic health technology assessment experts say, adding that talks on collaboration are also ongoing with HTA bodies outside the continent.

This week, Hologic announced it would pay $350m for uterine fibroid treatment firm Gynesonics; the US FDA authorized a Novocure cancer treatment and a surgical robot from CMR Surgical; and the IMDRF announced 15 new members.