Santa Clara, Calif.-based Cardiva Medical Inc. is looking to gain approval for Vascade Mvp, which is designed specifically for multi-access venous closure following electrophysiology (EP) procedures. Now, it is heralding results revealed at the American Heart Association's Scientific Sessions in Chicago backing the device, which is under review by the FDA.
Maxq AI Ltd.'s Accipio Ix intracranial hemorrhage (ICH) detection software scored U.S. FDA clearance. It aims to help in prioritizing the clinical assessment of adult noncontrast head computed tomography (CT) cases that exhibit indications of ICH, or brain bleed, resulting from stroke or trauma.
Madison, Wis.-based Neuropointdx, a division of Stemina Biomarker Discovery, unveiled the Npdx AA test, which identifies metabolic subtypes associated with autism spectrum disorder (ASD). The test, provided through Neuropointdx's CLIA-certified laboratory, may be used to screen children as young as 18 months.
The FDA granted breakthrough device designation for Cerus Corp.'s pathogen-reduced cryoprecipitate product candidate. The basis of the designation for the Concord, Calif.-based company's product is improved treatment of massive hemorrhage.
Redwood City, Calif.-based digital health company Carrot Inc. scooped up a $25 million round to back commercialization of its Pivot smoking cessation program. Johnson & Johnson Innovation (JJDC) led the round, which was joined by New York Life Ventures and existing investors Khosla Ventures, Marc Benioff, Carrot founder David Utley and R7 Partners.
