Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Vela Diagnostics.
The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic. The term of the delays of compliance for several of these rules is not uniform, ranging from “late 2020” to “spring 2021,” and vendors thus will have to be vigilant to ensure they do not cross any compliance tripwires.
TORONTO – A portable DNA-based test kit developed by Ottawa-based Spartan Bioscience Inc. has received Health Canada approval for COVID-19 testing – this at a time when hospitals are under enormous pressure to meet increased testing demand.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Baxter, Biocomposites, Cagent Vascular, Mevion.
BOGOTA, Colombia – Med-tech companies across Latin America that have traditionally focused on domestic and regional markets are in a race against time to supply ventilators to deal with worsening COVID-19 outbreaks.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Predictive Technology Group, SC Worx, Spectrum DNA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Life Spine, Mobidiag, Seegene.
The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy.
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
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