{"entity":{"id":"stemtech-medical-devices","kind":"company","name":"Stemtech Medical Devices","aka":["Eva Scalp Cooling System"],"tldr":"Stemtech Medical Devices of Navi Mumbai makes the Eva scalp cooling system, the most recent machine cleared by the FDA to reduce chemotherapy hair loss.","summary":"Stemtech Medical Devices, Navi Mumbai, received 510(k) K252289 on 25 November 2025 for the Eva Scalp Cooling System, for patients with solid tumours, with DigniCap Delta as predicate; the summary states that \"no clinical data was necessary to determine the substantial equivalence of this device\". It is the seventh authorisation under the FDA scalp-cooling product code.","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K252289: Eva Scalp Cooling System (25 November 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252289"}],"tags":["machines-wave3"],"related":[],"cancers":[],"sections":["rejuvenation","supportive-care"],"technologies":["scalp-cooling"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo machines inventory (openFDA, accessdata.fda.gov, ClinicalTrials.gov v2, Europe PMC, maker pages)","editedOn":"2026-11-04"},"hq":"Navi Mumbai","country":"IN","companyType":"devices","investors":[],"funding":[]},"route":"/companies/stemtech-medical-devices/","neighbours":{"section":[{"id":"rejuvenation","kind":"section","name":"Recovery & Rejuvenation","route":"/fronts/rejuvenation/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"}],"technology":[{"id":"scalp-cooling","kind":"technology","name":"Scalp cooling (cold caps: DigniCap, Paxman)","route":"/technologies/scalp-cooling/"}],"roadmap":[{"id":"chemo-chair-comfort-devices-roadmap","kind":"roadmap","name":"Comfort devices at the chemotherapy chair: scalp cooling, cold caps, limb cryocompression and infusion chairs","route":"/roadmaps/chemo-chair-comfort-devices-roadmap/"}]}}