"Not to mention that we could get Breakthrough Device Designation any day now."
That could well be the case Eire. A link below to an article - FDA Anticipates Fewer Novel Medical Device Approvals in 2022 -
https://www.fiercebiotech.com/medtech/fda-anticipates-fewer-novel-medical-device-approvals-2022?utm_source=email&utm_medium=email&utm_campaign=LS-NL-FiercePharma+Tracker&oly_enc_id=9563F4064234D3D
"Not to mention that we could get Breakthrough Device...
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