Portland, Oregon-based startup VisCardia announced Thursday it received breakthrough device designation from FDA for its heart failure device, teeing it up to benefit from additional regulatory support as it works to show the therapy can help patients stay physically independent for longer.
VisCardia's news followed a similar announcement earlier in the week from CytoSorbents, which on Monday said it had secured breakthrough status for a device designed to draw the blood thinner ticagrelor out of patients, cutting the risk of cardiac surgery complications.
Also on Monday, Endospan, a startup based in Israel, said FDA had awarded breakthrough designation to Nexus, a stent graft system the company sees as an alternative to open-chest surgery in patients who have difficult-to-treat aortic arch anatomy.
FDA appears to be continuing to grant breakthrough device designations despite disruptions to some normal operations caused by the COVID-19 pandemic. The breakthrough designations revealed this week cover the latest in a series of products to get the regulatory status over the past month.
Last week, The Learning Corp secured the designation for a speech therapy app that delivers cognitive, speech and language therapy to stroke patients at home.
Earlier in the month, FDA granted breakthrough status to DNAe’s sequencing platform and first assay. The platform is designed to automate the entire process, thereby enabling non-specialist users to quickly generate diagnostic results at the point of care.
Around the same time, noninvasive respiratory support devices Vapotherm said FDA awarded the regulatory status to a module designed to help healthcare professionals maintain a target blood oxygen level when treating patients with the company’s Precision Flow humidification systems. Days after disclosing the breakthrough status, Vapotherm presented preliminary first quarter results that far exceeded its expectations. First quarter sales came in at around $18.9 million, 36% above the top end of Vapotherm’s range, as the pandemic surged demand for Precision Flow systems and disposables in the U.S. and Europe.
Details of another breakthrough designation emerged late last month when AgNovos Healthcare said FDA had granted the status to a treatment for stable vertebral compression fractures.