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