Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerus, Ortho Clinical Diagnostics, Profound Medical.
LONDON – Long-awaited guidance on the EU regulation for in vitro diagnostics (IVD) that comes into force in May 2022 arrived as the industry increased its calls for implementation to be postponed, citing the extent to which the COVID-19 pandemic has derailed work on bringing products into compliance with the new rules.
Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and RenalytixAI, has received emergency use authorization from the U.S. FDA for its semi-quantitative SARS-CoV-2 IgG antibody test kit. Known as COVID-Seroklir, the test determines the presence and precise level of IgG antibodies. It has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acarix, Applied DNA, Co-Diagnostics, Corticometrics, Kantaro, Rapidrona.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA lists entities recognized under ASCA program.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Braid Health, Cardiawave, Cepheid, Fluidigm, Neuronetics, Zymo Research.
Hologic Inc. has gained approval from the U.S. FDA to add a diagnostic claim to its HIV type 1 viral load monitoring assay. This makes the Aptima HIV-1 Quant Dx assay the first dual-claim assay in the U.S., allowing both viral load monitoring and diagnosis. For laboratories that use the assay, the dual claim allows for consolidated testing on one automated platform, adding to efficiency.
The U.S. FDA cleared Alivecor Inc.'s Kardia AI V2 interpretive electrocardiogram (ECG) algorithm for use in its personal ECG app and devices. Currently, the Kardia line permits consumers to take a 30-second medical grade ECG at home and instantly see whether they are exhibiting symptoms of atrial fibrillation, bradycardia, tachycardia or have normal heart rhythm.
Two U.S. federal agencies at the Department of Health and Human Services (HHS) have finalized rules that affect how drug and device makers interact with the health care system, but under the Congressional Review Act, neither rule can go into effect until February 2021. This timeline comes up a couple of weeks after President-elect Joseph Biden is sworn in, thus raising the risk that the new administration at HHS will either modify or overturn these rules altogether.
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