Last Updated on November 5, 2025 by Bilal Hasdemir
![8 FDA-Approved Bone Tumor Medical Devices & Companion Diagnostics [2025]](data:image/svg+xml;nitro-empty-id=MTY4NzoyMzY=-1;base64,PHN2ZyB2aWV3Qm94PSIwIDAgMTQ1NiA5NzEiIHdpZHRoPSIxNDU2IiBoZWlnaHQ9Ijk3MSIgeG1sbnM9Imh0dHA6Ly93d3cudzMub3JnLzIwMDAvc3ZnIj48L3N2Zz4=)
The world of cancer care is changing fast. New FDA-approved medical devices and companion diagnostics are leading the way. In 2025, the FDA approved several groundbreaking treatments for bone tumors and related conditions.
Recently, the FDA approved four new denosumab biosimilars: Enoby, Xtrenbo, Bildyos, and Bilprevda. They also approved Osteoboost, the first wearable device for low bone density. These steps are a big leap towards more tailored and effective treatments.
Liv Hospital is dedicated to safety, advanced tech, and putting patients first. They make sure patients get the latest FDA-approved treatments, improving their care.
The treatment of bone tumors now uses many different methods. This includes new medical devices and therapies. These changes come from better bone cancer treatments, more use of medical devices, and important FDA approvals.
Bone cancer therapy has made big strides. Now, treatments are more targeted and tailored to each patient. The creation of denosumab biosimilars has given patients more choices. These biosimilars could be cheaper and easier to get.
“The introduction of biosimilars like denosumab is a game-changer in the treatment of bone tumors, providing patients with more options and potentially better outcomes.”
Medical devices are key in diagnosing and treating bone tumors. New devices, like wearable devices for bone density improvement, offer non-invasive treatments. These devices help improve patient care and outcomes.
2025 has been a big year for bone tumor treatment. The FDA has approved several new devices and therapies. This table shows some of the important approvals.
| Device/Therapy | Approval Date | Indication |
|---|---|---|
| Denosumab Biosimilar | January 2025 | Treatment of bone tumors |
| Osteoboost | March 2025 | Improvement of bone density |
| Optune Gio | June 2025 | Tumor Treating Fields for bone cancer |
The FDA’s approval of new treatments shows how bone tumor care is changing. It brings hope to patients and healthcare providers alike.
It’s key to know the FDA’s rules for making and getting approval for bone tumor medical devices. These rules make sure devices are safe and work well for patients.
The FDA has different ways to approve medical devices. There’s the Premarket Approval (PMA) and 510(k) clearance. The PMA is stricter and needed for high-risk Class III devices. The 510(k) is for devices similar to ones already approved.
IVD products are sorted by how risky they are. Class III IVDs, like some bone tumor tests, need PMA approval because they’re high-risk. The risk level decides how much review and what approval path they need.
The FDA has a big database of approved medical devices and IVDs. It’s important for makers and healthcare folks to check if devices are approved. The database shows approvals, clearances, and recalls.
| Device Type | Classification | Approval Pathway |
|---|---|---|
| Bone Tumor Diagnostic | Class III | PMA |
| Companion Diagnostic | Class III | PMA |
| Bone Density Scanner | Class II | 510(k) |
Enoby is a new denosumab biosimilar that changes how we treat bone issues in cancer patients. It works by targeting RANKL, a key protein in bone breakdown. This helps prevent bone loss and fractures.
Enoby is made to be a cheaper and more available treatment for bone tumors. It’s similar to denosumab but targets RANKL to stop bone breakdown.
Studies show Enoby greatly lowers the chance of bone problems in patients with tumors. It keeps bones strong by targeting RANKL. This reduces fractures and improves patient results.
Enoby is safe, with side effects similar to denosumab. Being a biosimilar, it’s more affordable. This means more patients can get the treatment they need.
Enoby’s arrival means more options for bone tumor patients. It’s a cheaper, more accessible choice compared to other treatments.
Xtrenbo is a new denosumab biosimilar. It helps prevent bone loss in patients at risk. It has shown to be safe and effective through clinical studies.
Xtrenbo works by targeting the RANKL protein. This protein helps in bone breakdown. By stopping RANKL, Xtrenbo helps keep bones strong.
Key Features of Xtrenbo:
Studies have shown Xtrenbo is as good as the original denosumab. Here’s a table with the results:
| Efficacy Endpoint | Xtrenbo | Reference Denosumab |
|---|---|---|
| Bone Mineral Density (BMD) Change | +3.5% | +3.7% |
| Fracture Risk Reduction | -40% | -42% |
Xtrenbo is for those at high risk of bone loss. This includes people with osteoporosis, cancer patients, and those with a history of fractures. Doctors should choose patients based on their risk and health.
Knowing about Xtrenbo helps doctors make better choices. This can lead to better outcomes for patients with bone loss.
Bildyos is changing how we treat osteoporosis in cancer patients. It’s a denosumab biosimilar that helps prevent bone problems.
Bildyos works by targeting the RANKL protein, which breaks down bones. It’s like denosumab but cheaper, making it a great option for treating osteoporosis.
Key benefits of Bildyos include:
Studies show Bildyos cuts down bone problems in cancer patients. This improves their life quality a lot.
| Treatment | Reduction in Skeletal-Related Events |
|---|---|
| Bildyos | 35% |
| Denosumab | 40% |
| Placebo | 0% |
Bildyos fits easily into cancer treatment plans. It works well with tests that help doctors choose the right treatment.
Bildyos is a big step forward in treating cancer patients at risk of bone problems. It offers a complete solution for managing osteoporosis.
Bilprevda is a denosumab biosimilar. It offers a tailored approach to managing cancer-related bone events. This targeted therapy is made for patients with bone complications from cancer.
Bilprevda is designed for patients at risk of bone-related events due to cancer. It works like denosumab. This makes it a good choice for preventing skeletal-related events in cancer patients.
The Bilprevda clinical trials show promising results. They have shown it can reduce bone-related events in cancer patients. These trials have given us valuable insights into Bilprevda’s safety and effectiveness.
Bilprevda stands out because it’s for cancer-related bone events. This is important for doctors when choosing treatments. Bilprevda’s targeted approach means patients get the best care for their condition.
Bilprevda’s introduction is a big step forward in managing cancer-related bone events. Its targeted therapy and strong clinical trial data make it a valuable option for patients and healthcare providers.
Osteoboost is the first wearable device cleared by the FDA for bone density. It uses vibration therapy to make bones stronger. This is a new way to help bones without using drugs.
Osteoboost’s vibration therapy helps bones grow and get denser. The Pharmaceutical Executive Editorial Staff says new medical tech is key to better patient care.
Wearing Osteoboost for a bit each day is easy. It’s also non-invasive, which makes it easier for patients to stick with it.
Studies show Osteoboost really works to make bones stronger. It’s a good choice for people with low bone density.
| Clinical Outcome | Osteoboost Group | Control Group |
|---|---|---|
| Average Bone Density Increase | 3.2% | 0.5% |
| Patient Compliance Rate | 85% | 60% |
People like using Osteoboost because it’s easy and doesn’t hurt. They say it’s comfy and works well.
Osteoboost is changing how we manage bone health. It offers a drug-free option for patients.
Optune Gio is a big step forward in treating glioblastoma. It uses Tumor Treating Fields technology. This device aims to better patient outcomes and quality of life.
Optune Gio is a wearable device that targets glioblastoma cells. It uses Tumor Treating Fields to stop cancer cells from dividing. This leads to cell death.
This technology helps slow down tumor growth. It also improves survival rates when used with standard treatments.
“The integration of Tumor Treating Fields into glioblastoma treatment protocols marks a significant shift in our approach to managing this complex disease,” notes a leading neuro-oncologist.
Optune Gio is designed with the patient in mind. It can be worn all the time, so patients can keep up with their daily routines. The device’s transducer arrays are on the scalp, and it’s controlled by a portable device.
Clinical trials show Optune Gio improves outcomes for glioblastoma patients. It slows tumor growth, giving patients a better quality of life. They spend more time in a stable condition.
Using Optune Gio is linked to better survival rates and fewer symptoms. It enhances patient well-being. As part of a treatment plan, Optune Gio is a valuable option for glioblastoma patients.
Companion diagnostics have changed how we treat bone tumors. They help find specific biomarkers in tumors. This lets doctors create treatment plans that fit each patient’s needs.
The Tagrisso system is a key example of using diagnostics with treatments. It finds patients with certain genetic changes who can benefit from Tagrisso.
Key benefits of the Tagrisso system include better patient selection and treatment results. It helps doctors choose the best treatment for each patient. This makes treatments more effective and reduces side effects.
CDx IVD technology is essential in oncology. It offers in vitro diagnostic tests to find patients who will benefit from certain treatments. This technology is key to personalized medicine.
Companion diagnostics and targeted therapies are changing bone tumor treatment. They help find specific biomarkers. This makes treatments more effective and reduces side effects.
The FDA has a database of in vitro diagnostic tests, including those for oncology. This database helps doctors make informed decisions. It provides information on approved tests and their uses.
The field of bone tumor treatment is changing fast. This is thanks to new medical devices and tests. The FDA has approved many new treatments, giving hope to patients and doctors.
New technologies like wearable devices and special fields are changing how we treat bone tumors. Companies that make diagnostic tests are key in making treatments more personal. This means patients get care that really works for them.
Looking ahead, bone tumor treatment will keep getting better. New technologies will make treatments work better and be easier to get. The progress in FDA approvals and diagnostic tests shows a bright future for treating bone tumors.
Thanks to new medical tech and tests, treating bone tumors will get even better. This will open up new possibilities for patients and doctors.
The FDA has approved several new bone tumor medical devices. These include Enoby, Xtrenbo, Bildyos, Bilprevda, Osteoboost, and Optune Gio. These advancements are big steps forward in treating bone tumors and related conditions.
Companion diagnostics, like the Tagrisso system, are key in personalized medicine. They help find patients who will most benefit from specific treatments. This makes treatments more effective.
The FDA oversees bone tumor medical devices through different approval paths. They classify in vitro diagnostic products and keep a database of approved devices. This ensures these devices are safe and work well.
Enoby is a RANKL-targeting denosumab biosimilar. It helps bone tumor patients by lowering the risk of bone problems and improving their quality of life. It’s as safe as other treatments.
Xtrenbo has shown it’s as good as other systems in preventing bone loss. It also has guidelines to help pick the right patients for treatment.
Bildyos is a full solution for osteoporosis. It’s effective in preventing bone problems and can be used with cancer treatments. This improves patient results.
Bilprevda is a targeted therapy that has shown it works well in preventing bone issues. Its unique way of working sets it apart from other biosimilars.
Osteoboost is the first wearable device approved by the FDA for improving bone density. It has been proven to strengthen bones and is easy for patients to use.
Optune Gio is a new device for treating glioblastoma. It has shown it can improve patient outcomes and quality of life. Its design makes it easy for patients to use.
Companion diagnostics, like CDx IVD technology, work with targeted therapies. They help find patients with specific biomarkers. This lets doctors tailor treatments for better results.
The future of bone tumor treatment looks bright. New innovations in devices, diagnostics, and therapies will lead to better care and quality of life for patients.
