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FINDER, Tap blood collector and SOZO

FINDER Device for Bedside G6PD Deficiency Testing Cleared in EU

Baebies, a company based in North Carolina, reports receiving FDA approval for its FINDER device. This tool can help identify patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency, a common enzyme deficiency predisposing to red blood cell breakdown that can lead to hyperbilirubinemia, jaundice, dark urine, and anemia. Common risk factors for these symptoms include infections, certain medications, and food such as fava beans. The FINDER device uses a small blood sample of approximately 50 μL. It provides results as fast as 15 minutes, making it easy to identify and closely monitor patients suffering from the condition.

Additionally, the facility to perform G6PD testing at the patient’s home would significantly impact managing hyperbilirubinemia. Finder bedside testing would be beneficial in specific areas of the world with a high prevalence of G6PD deficiency, such as Africa, Asia, the Mediterranean, and the Middle East; this could provide a comprehensive profile of treatment and avoidance of triggers.(1)

 

Baebies, a company based in North Carolina, reports receiving FDA approval for its FINDER device. This tool can help identify patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency, a common enzyme deficiency predisposing to red blood cell breakdown that can lead to hyperbilirubinemia, jaundice, dark urine, and anemia.

Common risk factors for these symptoms include infections, certain medications, and food such as fava beans. The FINDER device uses a small blood sample of approximately 50 μL. It provides results as fast as 15 minutes, making it easy to identify and closely monitor patients suffering from the condition.

 

Additionally, the facility to perform G6PD testing at the patient’s home would significantly impact managing hyperbilirubinemia. Finder bedside testing would be beneficial in specific areas of the world with a high prevalence of G6PD deficiency, such as Africa, Asia, the Mediterranean, and the Middle East; this could provide a comprehensive profile of treatment and avoidance of triggers. (1)

TAP At-Home Blood Collection System Now FDA Cleared

The Seventh Sense Biosystems company has FDA approval for its TAP device to be used at home by individuals for “wellness testing”. The TAP device tool can transform traditional blood collection with large needles, a bothersome and stressful experience, with the use of microneedles. This empowers the consumers to perform painless blood collection themselves at any place. 

TAP device tool can be placed on the upper arm and draw up to 100 μL, releasing anticoagulants if necessary to ensure the blood draw continues uninterrupted. Since patients or consumers do not see the needles, even children may not realize their blood is being taken if they are not told what the device is.(2)

The Seventh Sense Biosystems company has FDA approval for its TAP device to be used at home by individuals for “wellness testing”.

The TAP device tool can transform traditional blood collection with large needles, a bothersome and stressful experience, with the use of microneedles. This empowers the consumers to perform painless blood collection themselves at any place. 

TAP device tool can be placed on the upper arm and draw up to 100 μL, releasing anticoagulants if necessary to ensure the blood draw continues uninterrupted. Since patients or consumers do not see the needles, even children may not realize their blood is being taken if they are not told what the device is.(2)

SOZO System FDA Cleared for Protein Calorie Malnutrition Assessment

ImpediMed is a company based in California that won clearance from the FDA for its SOZO device to assess protein-calorie malnutrition and provides fluid status for patients suffering from congestive heart failure and liver disease. This device works as non-invasive bioimpedance spectroscopy that helps evaluate secondary lymphedema and offers a snapshot of fluid status and tissue composition as fast as 30 seconds.

The principal component is a physical device with hands and footplates fixed to a pedestal and controlled with an android tablet with the SOZOapp. A single SOZO measurement can provide critical data, including total body water, extracellular and intracellular fluid, fat mass, skeletal muscle mass, and body mass index.(3)

ImpediMed is a company based in California that won clearance from the FDA for its SOZO device to assess protein-calorie malnutrition and provides fluid status for patients suffering from congestive heart failure and liver disease. This device works as non-invasive bioimpedance spectroscopy that helps evaluate secondary lymphedema and offers a snapshot of fluid status and tissue composition as fast as 30 seconds.

 

The principal component is a physical device with hands and footplates fixed to a pedestal and controlled with an android tablet with the SOZOapp. A single SOZO measurement can provide critical data, including total body water, extracellular and intracellular fluid, fat mass, skeletal muscle mass, and body mass index.(3)

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