Checkout MedtechInsight'sUSFDAWarningLetterDataTracker here.
This chart lists device-related warning letters released by the US Food and Drug Administration in August 2021. If an inspection...
This is the first publicly released inspection-related warning letter sent to a Chinese company since the US FDA stopping sending investigators there in February 2020 because of the COVID-19 pandemic. A total of eight device-related missives were released by the agency in August.
Checkout MedtechInsight'sUSFDAWarningLetterDataTracker here.
This chart lists device-related warning letters released by the US Food and Drug Administration in August 2021. If an inspection...
Dexcom has recalled several models of its glucose monitoring receivers due to a speaker glitch that may suppress vital blood sugar alerts. The FDA designated the recall, which affects thousands of devices, as class I.
A recent FDA warning letter claims a Boston firm that specializes in wearable technology marketed a blood pressure device without agency approval. The company rejects the assertion and says the agency is out of step with federal law.
The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.
Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.