Company Product Description Indication Status
Abbott Laboratories, of Abbott Park, Ill. Heartmate 3 Implantable mechanical circulatory support device Patients with advanced refractory left ventricular heart failure The U.S. FDA approved updated labeling to allow for use in pediatric patients
Cerenion Oy, of Oulu, Finland C-Trend Artificial intelligence software integrated into the Bittium Brainstatus EEG system Processes EEG signals into diagnostic score Received the CE mark
Ecolab Inc., of St. Paul, Minn. Bioquell technology system Uses hydrogen peroxide vapor technology For decontaminating specific N95 respirators up to 4 times to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulate Received emergency use authorization from the U.S. FDA
Integrum AB, of Mölndal, Sweden Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant system For adults who have transfemoral (above-the-knee) amputations Received premarket approval from the U.S. FDA
Occlutech International AB, of Helsingborg, Sweden Atrial flow regulator Implantable device For pulmonary arterial hypertension Received breakthrough device designation from the U.S. FDA

Notes

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