Company Product Description Indication Status
Advanced Sterilization Products Inc., of Irvine, Calif. Sterrad Hydrogen peroxide vapor-based sterilization system Decontaminates compatible N95 respirators, allowing them to be reused twice after initial use Received emergency use authorization from the U.S. FDA
Axonics Modulation Technologies Inc., of Irvine, Calif. Next-generation rechargeable implantable neurostimulator for its r-SNM system Decreases the recharge interval of its implantable sacral neuromodulation device to once a month Treatment of urinary and bowel dysfunction Received U.S. FDA approval under a premarket approval supplement
Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J. BD SARS-CoV-2 Reagent Kit for BD Max system Molecular diagnostic test that runs on the BD Max system; returns results in 2-3 hours Qualitative detection of nucleic acid from SARS-CoV-2 in nasal, nasopharyngeal and oropharyngeal swab samples Received emergency use authorization from the U.S. FDA
Becton, Dickinson and Co. (BD), of Franklin Lakes, N.J. BD SARS-CoV-2 Reagent Kit for BD Max system Molecular diagnostic test that runs on the BD Max system; returns results in 2-3 hours For use in diagnosing COVID-19 Received the CE mark
Intact Vascular Inc., of Wayne, Pa. Tack endovascular system (4F) Metal implant For precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries (below-the-knee post-angioplasty dissection repair) Received U.S. FDA approval
The Learning Corp, of Newton, Mass. Speech Therapy (ST) App Digital therapeutic Provides accessible cognitive, speech and language therapy to stroke patients Received breakthrough device designation from the U.S. FDA
Mobidiag Ltd., of Espoo, Finland Amplidiag COVID-19 assay Molecular diagnostic test; runs on Mobidiag's Amplidiag Easy platform, which can process 48 samples in less than 3 hours For the qualitative determination of SARS-CoV-2 (orf1ab and N genes) from nasopharyngeal swabs Received emergency use authorization in Finland
Spectral Medical Inc., of Toronto PMX cartridge Hemoperfusion device that removes endotoxin from the bloodstream Treatment for septic shock U.S. FDA approved a supplemental investigational device exemption for use in patients with COVID-19

Notes

For more information about individual companies and/or products, see Cortellis.

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