Company Product Description Indication Status
Caption Health Inc., of Brisbane, Calif. Caption Guidance software update AI-guided medical imaging acquisition system Helps users make specific transducer movements to optimize and capture a diagnostic-quality image Received U.S. FDA clearance
Cardiofocus Inc., of Marlborough, Mass Heartlight X3 Endoscopic ablation system For the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation Received U.S. FDA approval
Cytosorbents Corp., of Monmouth Junction, N.J. Cytosorb Blood purification technology For the removal of rivaroxaban (Xarelto; Bayer, Jansenn/Johnson & Johnson) during cardiothoracic surgery requiring cardiopulmonary bypass Received expanded E.U. approval
Helius Medical Technologies Inc., of Newtown, Pa. Portable Neuromodulation Stimulator (PoNS) Nonimplantable medical device For the short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and gait deficit due to mild and moderate symptoms from multiple sclerosis to be used in conjunction with physical therapy The U.S. FDA granted breakthrough device designation for the treatment of gait deficit due to symptoms of multiple sclerosis
Optiscan Biomedical Corp., of Hayward, Calif. Optiscanner 7000 Automated, continuous, multivariate, bedside monitor Allows for the monitoring and trending of glucose, lactate and central venous oxygen saturation levels from a single micro-sample of a patient's blood in the intensive care unit Received the CE mark
Ortho Clinical Diagnostics Inc., of Raritan, N.J. Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack Serology total antibody test; runs on the Vitros XT 7600 integrated system, Vitros 3600 immunodiagnostic system and Vitros 5600 integrated system For the qualitative detection of total antibodies (including IgA, IgG and IgM) to SARS-CoV-2 in human serum and plasma specimens Received the CE mark
Thermo Fisher Scientific Inc., of Waltham, Mass. Applied Biosystems Taqpath COVID-19 Combo Kit Real-time RT-PCR test; delivers test results within four hour For the qualitative detection of nucleic acid from SARS-CoV-2 (targets the ORF1ab, N and S genes) in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage specimens; previously approved for use on the Applied Biosystems 7500 Real-time PCR series instrument The U.S. FDA expanded emergency use authorization for use on specific configurations of Quantstudio 7 Flex and Quantstudio 5 Real?time PCR instruments; also adds the company's Magmax viral/pathogen II nucleic isolation kit as an alternative to RNA extraction reagents
Transit Scientific, of Salt Lake City XO Cross microcatheter platform Nontapered metal-alloy catheter platform For guidewire support, exchange, and contrast media injection in the peripheral vasculature Received 510(k) clearance from the U.S. FDA

Notes

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

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