Neola Medical receives FDA Breakthrough Device Designation
The program enables prioritized regulatory review and direct agency engagement for the neonatal lung collapse detection technology.
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Medical device company developing continuous neonatal lung monitoring
neolamedical.comLast updated
In short: Neola Medical received FDA Breakthrough Device Designation for its neonatal lung monitoring tech and secured SEK 32.5m in funding.
The program enables prioritized regulatory review and direct agency engagement for the neonatal lung collapse detection technology.
Neola Medical secured ~SEK 32.5 million through a rights issue, obtained a US patent, and narrowed its strategic focus to detect lung collapse in neonates during this period.
The subscription rate was 70 percent and the company receives approximately SEK 32.5 million before issue costs.
The subscription period ends on June 17, and investors are urged to act today.
The good news from the American authorities, which only a handful of Swedish companies have received in the past five years, caused Lundabolaget's stock to surge.
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