Portal Diabetes’ insulin pump receives FDA breakthrough device designation
The designation supports priority engagement with the FDA as Portal Diabetes advances clinical trials and regulatory submissions.
18 February 2026
18 February 2026
The designation supports priority engagement with the FDA as Portal Diabetes advances clinical trials and regulatory submissions.
The therapy dosing provides clinical outcomes consistent with those of the earlier approved bi-weekly subcutaneous regimen.
The acquisition will combine two portfolios that focus on advancing spine care solutions.
Recruitment is ongoing in China and Australia, with IND clearance now obtained in the US.
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