regulatory
confidence high
sentiment negative
materiality 0.80
RemSleep DeltaWave reclassified as implantable by FDA; must resubmit 510K after new testing
RemSleep Holdings Inc.
- FDA reclassified DeltaWave as implantable device; company withdrawing current 510K application.
- Additional testing required; RemSleep engaging consultants to satisfy new classification.
- FDA confirmed all previously submitted test results will apply to the new 510K submission.
- Company plans to submit next 510K for next-generation Nasal Pillows interface soon.
- OTCQB application is in final stages of completion by securities attorney.