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United States

Set Alert for Policy and Regulation United States

FDA Recommends Further Limiting Use Of Laparoscopic Power Morcellation

The US FDA is updating its labeling guidance on laparoscopic power morcellation to reflect new evidence showing the treatment may pose a higher cancer risk in older women, as well as to add discussion of containment systems.

Gynecology & Urology Guidance Documents FDA

Latest From United States, Policy & Regulation

Biologics Boss: FDA Looking For Alternative Medical Device Sourcing Due To COVID-19

Peter Marks, head of the US FDA’s biologics center, says the agency is looking for alternative sourcing and manufacturing of medical products imported from China, including medical devices, to ward off potential shortages that could result from the ongoing coronavirus crisis and containment.

Infectious Diseases Manufacturing

Top Lobbyist: User Fee Deal Should Focus On Agreements Already In Place

In an exclusive and wide-ranging interview with Medtech Insight, Mark Leahey, president of the Medical Device Manufacturers Association, said the previous four Medical Device User Fee negotiations with the FDA have set a strong foundation for the industry and the next round of negotiations should focus on tweaking past deals that are already in place.

Regulation Lobbying

Performance Issues With CDC’s COVID-19 Assay Reagent Slows Rollout Of Test Kits To US States

A reagent in a batch of COVID-19 tests shipped by the US Centers for Disease Control and Prevention to state laboratories “wasn’t performing consistently,” a top CDC official says, so the agency is reformulating it – slowing down the labs’ ability to use the diagnostic, which yielded inconsistent results when quality-tested. But waiting in the wings are commercial coronavirus test kits being developed by Qiagen and Cepheid; both firms say they’ll submit the kits to the FDA for emergency-use approval.

Infectious Diseases Regulation

Study Says FDA Waited Too Long To Ban Pelvic Mesh For POP Repairs

Roughly 18.5% of patients who received reinterventions to fix mesh implants for pelvic organ prolapse (POP) repair experienced complications they will likely endure for the rest of their lives, and they also face a 2.5% higher rate of further surgeries than non-mesh patients, says a recent 54,194-woman study detailed in Obstetrics & Gynecology. The study authors lay out a case that the US FDA should have forced removal of mesh from the market sooner.

Regulation FDA

HHS Advances AI Priorities In Budget Ask

The US Department of Health and Human Services is asking Congress for $10m in its latest budget request specifically to advance the use of artificial intelligence to regulate FDA products and promote development of AI technology. The ask aligns with President Trump’s vision for government agencies to help make the US a leader in AI and machine learning products.

Regulation Policy

Experts: Chinese Tariff Cuts Good For Medtech, But Deliver Small Impact

Two top trade experts tell Medtech Insight that China’s recent decision to reduce tariffs is in response to the US government’s announcement that it, too, would reduce tariffs in an apparent bid to deescalate the seemingly never-ending trade war. Dropping tariffs will also help China meet its obligations under a so-called Phase 1 trade deal agreed to by the two countries.

Trade China
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