{"entity":{"id":"atos-medical","kind":"company","name":"Atos Medical","aka":["Atos Medical AB","Provox"],"tldr":"Atos Medical makes the Provox voice prostheses and the filters, tubes and covers people use after their voice box is removed.","summary":"Atos Medical AB, registered with the FDA at Horby, Sweden, holds FDA clearances for Provox Vega (K090455), Provox ActiValve (K092593), Provox FreeHands FlexiVoice (K141380) and the Provox Micron heat and moisture exchanger (K072582). It has 177 rows in Part IXA of the NHS Drug Tariff for November 2026, 137 of them tracheostomy breathing aids and 19 laryngectomy protectors.","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K090455: Provox Vega","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K090455"},{"label":"FDA 510(k) K072582: Provox Micron HME","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K072582"},{"label":"NHS Drug Tariff Part IX, November 2026 (NHSBSA, CSV)","url":"https://www.nhsbsa.nhs.uk/sites/default/files/2026-10/Drug%20Tariff%20Part%20IX%20November%202026.csv"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":[],"sections":["supportive-care","devices"],"technologies":["voice-prostheses","laryngectomy-stoma-care-devices"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, NHS Drug Tariff Part IX, FDA, maker and society pages)","editedOn":"2026-11-04"},"hq":"Horby","country":"SE","companyType":"devices","website":"https://www.atosmedical.com/","investors":[],"funding":[]},"route":"/companies/atos-medical/","neighbours":{"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"laryngectomy-stoma-care-devices","kind":"technology","name":"Heat and moisture exchangers, laryngectomy tubes and stoma protectors","route":"/technologies/laryngectomy-stoma-care-devices/"},{"id":"voice-prostheses","kind":"technology","name":"Voice prostheses after laryngectomy (Provox, Blom-Singer)","route":"/technologies/voice-prostheses/"}]}}