The US Food and Drug Administration (FDA) has cleared Bindex, a device manufactured by Finnish firm Bone Index Ltd. The device has the capability to diagnose osteoporosis. It takes ultrasounds of the bones to evaluate the cortical bone thickness of the tibia and provides a measurement of the density index of bone mineral that is normally derived from dual-energy X-ray absorptiometry (DXA) bone densitometry systems.
Bone Index was founded in 2011 and focuses on developing measuring devices for osteoporosis screening and diagnosis.
The device is connected to a personal computer running the Bindex software and can perform the task within 30 seconds at the point of care to prevent delays or further damage. Clinical trials were held to check the effectiveness of the device. The system was able to detect osteoporosis with 90% sensitivity and specificity without exposing patients to radiation.
The company has claimed that their device can produce results as accurate and precise as those of DXA. Hence it is better at providing similar results as compared to the high running costs and limited mobility of DXA machines. Moreover, there is no need for physician referral since the device is radiation-free.
“The clearance process with the FDA was straightforward despite the novel approach introduced with Bindex. The technique is based on extensive clinical evidence, and with the effectiveness of Bindex, the current care of osteoporosis can be significantly improved,” says Bone Index’s CTO, Dr Janne Karjalainen.
Dr Ossi Reikkinen, the CEO of Bone Index, believes that their product is quite unique in the world and that its reliability and portability allows newer and economically feasible diagnoses of osteoporosis.
What Is A Bone Density Scan (DXA)?
Bone density scanning, also called dual-energy X-ray absorptiometry (DXA) or bone densitometry is a bone mineral density (BMD) measuring technique that uses advanced X-ray technology.
An X-ray radio graph is a non-invasive procedure that physicians use to detect non-visible medical conditions such as fractures and deep tissue damages. X-rays are the oldest and most commonly used form of medical imaging. They involve exposing parts of the body to ionizing radiation in order to capture medical images.
DXA is most often performed on hips and spinal cord. In some adults and children, whole body might be scanned. DXA tests can also assess an individual’s risk for developing fractures, hence they are extensively used in the treatment of osteoporosis during the detection phase.
There are two types of DXA devices: central and peripheral. The central device is used to measure bone density in the hips and spine whereas peripheral devices are used to measure bone density in wrists, fingers or heels. The central device is a large table-like surface that is available in hospitals and clinics, whereas the peripheral device is a small, portable box-like tool.
Bindex — A Radiation-Free Device
Osteoporosis remains a much underdiagnosed disease, with around 75% of osteoporosis patients going undiagnosed. It is responsible for 2 million broken bones each year in the US. These fracture costs add up to approximately $19 billion. According to experts, the cost of fractures is expected to rise to $25.3 billion by 2025.
There are a lot of health risks associated with radiation exposure. In severe cases, exposure can damage cells in the body, which may result in cancer, hair loss, birth defects, heart disease, nausea, vomiting, weight loss and even death.
Hence, due to high costs of standard osteoporosis screening procedures and the risk of exposure to radiation, Bone Index came up with Bindex.
What Is Osteoporosis?
Osteoporosis causes bones to become weak and brittle. In fact, bones become so weak that simple acts such as standing up or bending can break bones. Most common osteoporosis-related fractures occur in the spine, hips or the wrists.
Bones are living tissue that are constantly being degenerated and replace by new healthy bone tissue. In osteoporosis, the rate of bone tissue degeneration is much higher than the rate of formation of health tissue.
Osteoporosis affects all genders and all races. But women, especially over the age of 50, are four times more at the risk of developing osteoporosis compared to men, due to their light frames and longer life spans.
Around the age of 30, bone density starts to decrease naturally since maximum bone density has been achieved by then. Osteoporosis is also linked to genetic factors.
Some of the signs and symptoms of osteoporosis include back pain, fatigue, stooped structure and easily damaged bones.
How likely you are to develop osteoporosis depends partly on how much bone mass you attained in your youth. The higher your peak bone mass, the lower your risk of developing osteoporosis in later years.
Hormones can greatly affect the onset of osteoporosis. Lower sex hormones tend to weaken bones. That is why women who reach menopause earlier have reduced levels of estrogen which can greatly increase the chances of developing osteoporosis.