MVITRO’s needle-free blood sampling device ORTIV wins FDA approval (2024)

MVITRO, a Koreanlaser-based home healthcare devices maker, said Tuesday that its first device, ORTIV, has received 510(k) clearance from the U.S. FDA.

ORTIV is a medical device that uses lasers to painlessly draw blood and measure blood glucose levels, eliminating the needfor disposable needles. The glucose readings are instantly transmitted to MVITRO’s dedicated app for real-time monitoring.

An MVITRO official said the device has been praised for “significantly reducing pain, making blood sampling nearly painless.” By using micro-lasers instead of needles, ORTIV minimizes skin damage and eliminates infection risks through its high-temperature laser technology.

Following FDA approval, the offical reported a surge in inquiries from global pharmaceutical and medical device companies about ORTIV’s potential in the North American market. Applied Science Inc. (ASI), a U.S.-based medical equipment supplier, signed a contract with MVITRO before the FDA approval. Additionally, Vitalant, one of the largest blood donation organizations in the U.S., is collaborating with MVITRO to co-develop a painless, laser-based hemoglobin measurement device.

The MVITRO official added that, while "many companies and hospitals are showing interest,"details cannot be disclosed due to ongoing contracts. “The ultimate goal is B2C, but right now we’re seeing significant interest from medical device companies, pharmaceutical companies, and hospitals,” the official said.

One of Korea’s pharmaceutical giants, which the company has not disclosed, is preparing to exclusively distribute ORTIV, while MVITRO is receiving inquiries about exporting the device to Europe, China, and Southeast Asia. The company expects to gain sales approval for ORTIV in Korea by the first half of next year and in Europe by the second half.

MVITRO is also developing a painless laser blood sampling device for diagnosing various diseases, commissioned by Japan’s Toyobo, a manufacturer of enzymes, antibodies, and antigens for diagnostic applications.

According to the Korea Disease Control and Prevention Agency (KDCA), 16.3 percent of Korean adults over 30 had diabetes in 2021, affecting an estimated 6 million people. When including prediabetics, approximately 63 percent of adults—or 23 million people—require management. Globally, around 1 billion people have diabetes, with an estimated 2.5 billion, including prediabetic individuals, needing care.

“We spent seven years developing this technology due to the challenges of reducing pain during blood sampling,” said MVITRO CEO Lee Young-woo. “We understand how stressful blood sampling is for diabetes patients and wanted to make it nearly pain-free with ORTIV, which we believe is a groundbreaking solution.”

Lee emphasized that ORTIV provides an innovative alternative to the painful blood sampling methods used by type 1 and severe diabetes patients who rely on continuous glucose monitoring (CGM) devices.

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