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BioWorld - Sunday, February 5, 2023
Home » Topics » Regulatory

Regulatory
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Regulatory actions for April 27, 2020

April 27, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Carmell, Carsgen, Cytodyn, Diffusion, Eiger, Green Valley, Halozyme, Janssen, Mateon, Neurocrine, Polyneuron, Takeda.
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Man clutching heart

Viscardia gains FDA breakthrough designation for diaphragm implant to treat heart failure

April 24, 2020
By Stacy Lawrence
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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.
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Regulatory front for April 24, 2020

April 24, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Bayer.
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Regulatory action for April 24, 2020

April 24, 2020
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Vela Diagnostics.
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Laptop, stethoscope, medical icons, health professional

CMS, ONC offer enforcement discretion for EHR rules

April 24, 2020
By Mark McCarty
No Comments
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.
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Regulatory actions for April 24, 2020

April 24, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arch, Biosig, Innovent, Janssen, Lilly, Oryzon, Sanofi, Viralclear.
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Regulatory actions for April 23, 2020

April 24, 2020
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Amidebio, Caladrius, CNS Pharma, Cstone, Immuneoncia, Immunomedics, Merck and Co., Rafael, Revive, Samsung Biologics, Vitalis.
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Laptop, stethoscope, medical icons, health professional

CMS, ONC offer enforcement discretion for EHR rules

April 23, 2020
By Mark McCarty
No Comments
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.
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4-23-spartan-cube.png

DNA-based Spartan Cube to test for COVID-19 in Canada

April 23, 2020
By David Godkin
No Comments
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.
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Regulatory front for April 23, 2020

April 23, 2020
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The latest global regulatory news, changes and updates affecting medical devices and technologies, including: KPMD.
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