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The device is implanted through a vein in the groin or neck into the right side of the heart and then into the RVOT, using a thin, hollow catheter with a collapsed Harmony valve on the end. Read More
The EU’s Medical Device Coordination Group (MDCG) has clarified minimum performance requirements for devices intended to detect antibodies against the SARS-CoV-2 virus in a new guidance. Read More
The FDA should refine its processes for breakthrough device designation to better reflect the risks and benefits associated with such devices, researchers from three prominent medical schools advised in a New England Journal of Medicine article. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to resume in-person inspections starting March 29 but it will adopt a hybrid approach that allows for both remote and on-site elements. Read More
The Center for Devices and Radiological Health (CDRH) gives devicemakers concrete examples of real-world evidence (RWE) used in premarket and postmarket submissions in a newly released report. Read More