The FDA has cleared Drawbridge Health’s blood collection device designed to help monitor long-term blood sugar levels in people with diabetes, which the company describes as easier and less painful than a hypodermic needle.
The OneDraw single-use device, about the size of a computer mouse, takes blood samples from the capillaries of an adult’s upper arm using a set of tiny lancets and light suction. Though it is intended to be used by a healthcare professional, Drawbridge says the system allows blood testing to be performed anywhere.
After the push-button device is placed on the skin, the sample is collected without any sight of blood or needles, and is stabilized within a detachable cartridge for transport. The company’s A1c test is then performed by a designated clinical laboratory.
Drawbridge was incubated and spun out of GE Healthcare and GE Ventures in 2015, with the goal of eliminating the need for phlebotomy and trained technicians, or having a patient travel to blood draw centers.
"Drawbridge Health was founded with the vision and intent to categorically and positively change the nature of blood-based diagnostic testing, improving both the collection process and patient experience," CEO Lee McCracken said in a statement.
"Our 510(k) clearance is a critical milestone as we make our founding vision a reality,” said McCracken, who previously served as CEO of Gensignia Life Sciences and Pathwork Diagnostics. “We look forward to making our novel technology commercially available soon."
A previous clinical study showed strong correlations between OneDraw’s HbA1c results and traditional venous blood samples, alongside a patient preference for the device compared to venipuncture or fingersticks, the company said.