Product/Vendor Updates

acupebble
Product/Vendor Updates

New UK HSAT AcuPebble SA100 Clears FDA

AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA. The device, developed and commercialized by UK-based medical device company Acurable, builds on more than ten […]

alung hemolung de novo clearance
Product/Vendor Updates

FDA Grants the Hemolung De Novo Clearance

ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company De Novo clearance for the Hemolung Respiratory Assist System. The Hemolung System is the first and only […]