BetaBionics’ iLet and the MAUDE Red Flag: The Severe Hypo Signal You Can’t Ignore
BetaBionics’ iLet took a market hit in January due to lower than expected user growth — but user chatter about overdosing and volatility pushed Diabettech to dig deeper. Using MAUDE (via openFDA) and a severity-conditioned lens, we found iLet’s serious reports skew strongly toward ultra-severe hypoglycaemia markers, while Omnipod 5’s severe signature skews toward DKA.