US Senate Approves US-Mexico-Canada Agreement Championed By Industry
The US Senate overwhelmingly approved a bill on 16 January to implement the US-Mexico-Canada agreement, which includes a new chapter on the handling of medical devices supported by the medtech industry.
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2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight
Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.
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.
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.