- Thorne HealthTech ( NASDAQ: THRN ) said its blood collection device OneDraw was certified in Japan as a medical device after being cleared by the Pharmaceutical and Medical Devices Agency (PMDA).
- "We appreciate the help from our partners in Japan because we believe this will create many additional opportunities to expand our relationships globally, while we continue to move forward on a similar regulatory pathway in the United States," said Thorne CEO Paul Jacobson.
- The company noted that OneDraw is already approved by the FDA as a class 2 medical device, and it has a European Conformity mark for supervised use by health-care professionals to collect blood samples to measure HbA1c for monitoring the long-term control of blood sugar (glucose) in diabetic individuals.
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Thorne HealthTech's blood collection device OneDraw gets clearance in Japan