Company Product Description Indication Status
Abiomed Inc., of Danvers, Mass. Impella ECP Expandable cardiac power (ECP)heart pump For short-term mechanical support in patients undergoing a high-risk percutaneous coronary intervention, to provide both circulatory support and left ventricular unloading The U.S. FDA has approved its investigational device exemption application to start an early feasibility study
Medtronic plc, of Dublin Resolute Onyx Drug-eluting stent For percutaneous coronary intervention Received the CE mark for a 1-month dual antiplatelet therapy indication for high bleeding risk patients implanted with the Resolute Onyx
Opti Medical Systems Inc., of Roswell, Ga. Opti SARS-CoV-2 RT-PCR laboratory test kit Uses real-time reverse transcription polymerase chain reaction (RT-PCR) technology; provides results in 2-3.5 hours For the detection of SARS-CoV-2 Received the CE mark
Opti Medical Systems Inc., of Roswell, Ga. Opti DNA/RNA Magnetic Bead Kit To be used with the OPTI SARS-CoV-2 RT-PCR test kit For nucleic acid extraction from respiratory samples Received emergency use authorization from the U.S. FDA

Notes

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

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