The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Apollo Endosurgery, Ariosa, Illumina, Roche, Verinata Health.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Livanova, Personal Genome Diagnostics.
Portland, Ore.-based startup Viscardia Inc. has received breakthrough device designation from the FDA for its implantable Visone system to treat moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony. The minimally invasive implant works by stimulating a specific portion of the diaphragm.
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.
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