Is Osteoboost FDA Approved? Navigating the Facts on This New Bone Health Device

October 10, 2025 •

3 min read

While many people associate FDA approval with new drugs, Osteoboost is not a medication but a wearable medical device. In early 2024, the U.S. Food and Drug Administration granted it clearance through the De Novo pathway, a distinct regulatory process from that for pharmacological agents.

Quick Summary

Osteoboost is a wearable vibration therapy device that received FDA clearance, not drug approval, for treating osteopenia in postmenopausal women. It provides a non-drug alternative to slow bone loss.

Key Points

FDA Clearance, Not Approval: Osteoboost is a wearable medical device that received FDA clearance as a Class II device, not standard FDA approval for a drug.
Non-Pharmacological Treatment: It is a non-drug, non-invasive therapy that uses calibrated vibration to stimulate bone growth in the spine and hips.
Indication for Osteopenia: The device is cleared for use in postmenopausal women with osteopenia (low bone density), not osteoporosis.
Clinically Proven for Bone Loss: A 12-month sham-controlled clinical trial showed that consistent use of Osteoboost significantly reduced the decline in bone strength and density in the target population.
No Serious Side Effects: The clinical trial found no serious adverse events related to the device, with reported side effects being mild and reversible upon cessation of use.
Prescription Only: Despite being a device, Osteoboost requires a prescription from a healthcare provider.

What is Osteoboost and How is it Regulated by the FDA?

Osteoboost, developed by Bone Health Technologies, is a prescription-only wearable medical device for treating osteopenia, or low bone density, in postmenopausal women. Instead of undergoing the FDA approval process for drugs, Osteoboost received FDA clearance as a Class II medical device through the De Novo pathway. This pathway is for novel devices considered low-to-moderate risk that do not have a comparable device already on the market.

The device is a belt designed to deliver targeted vibration to the bones in the spine and hips, a concept influenced by NASA research on bone loss in space. By providing this mechanical stimulation, it aims to promote bone health in these vulnerable areas.

The Distinction: FDA Clearance vs. FDA Approval

It's important to understand the different regulatory pathways for medical products:

FDA Approval for Drugs: This is a rigorous process for medications and biological products where manufacturers must demonstrate safety and effectiveness through clinical trials.
FDA Clearance for Devices: Many medical devices, including Osteoboost through the De Novo pathway, are cleared if they are shown to be safe and provide reasonable assurance of effectiveness for their intended use. This is distinct from the drug approval process.
FDA Oversight of Supplements: Dietary supplements are regulated differently under DSHEA and do not require pre-market FDA approval for safety or effectiveness.

Clinical Evidence Supporting the FDA Clearance

Bone Health Technologies provided clinical trial data to the FDA for the De Novo classification. A randomized, sham-controlled trial involving postmenopausal women with osteopenia showed that consistent device use resulted in a statistically significant reduction in the decline of vertebral bone strength and density compared to the control group. The study also reported high patient adherence and no device-related serious side effects. It's worth noting the trial focused on changes in bone parameters and did not assess fracture risk reduction; the clearance is specifically for slowing bone decline in postmenopausal women with osteopenia.

Osteoboost vs. FDA-Approved Medications for Bone Health

Comparing Osteoboost to established bone health medications highlights their different approaches:


Feature	Osteoboost (Device)	Bisphosphonates (e.g., Fosamax, Reclast)	Denosumab (Prolia)	Raloxifene (Evista)
FDA Status	Cleared as a Class II medical device	Approved as a drug	Approved as a drug	Approved as a drug
Mechanism	Targeted vibration therapy stimulates bone growth	Slows down the natural breakdown of bone	Antibody that blocks bone breakdown	Acts like estrogen to reduce bone resorption
Form	Wearable belt	Oral tablets or intravenous (IV) infusion	Subcutaneous injection	Oral tablets
Target Population	Postmenopausal women with osteopenia	Postmenopausal women, men, and steroid-induced osteoporosis	Postmenopausal women and men with high fracture risk	Postmenopausal women
Side Effects	Mild, reversible effects (e.g., dizziness, muscle pain)	Gastrointestinal issues, jaw osteonecrosis (rare), atypical fractures (rare)	Hypocalcemia, skin infections, jaw osteonecrosis (rare)	Hot flashes, leg cramps, increased risk of blood clots

The Benefits and Limitations of Osteoboost

Benefits

Non-Pharmacological Option: Offers a drug-free alternative for managing bone health, particularly for those unable or unwilling to take medication.
Addresses Early Stage Bone Loss: Targets osteopenia, a condition where treatment options can be limited.
High Patient Adherence: Designed for convenient at-home use, which contributed to high compliance in studies.
Minimal Side Effects: Clinical trials reported only mild, transient side effects.

Limitations and Considerations

Prescription-Only: Requires a prescription from a healthcare provider.
Limited Indication: Currently cleared only for postmenopausal women with osteopenia, not osteoporosis.
Fracture Risk Unproven: While it showed reduced bone loss, its effect on fracture prevention was not evaluated in the pivotal trial.
Insurance Coverage: Coverage may vary depending on individual insurance plans.
Compliance is Key: Effectiveness observed in studies depended on consistent use.

Conclusion: Is Osteoboost FDA Approved?

No, Osteoboost is not FDA approved; it is FDA-cleared as a Class II medical device through the De Novo pathway. This means it has met FDA requirements for safety and effectiveness for its specific indication: slowing the decline in bone strength and density in postmenopausal women with osteopenia. It provides a non-drug option for bone health management, but consistent use is necessary, and its impact on fracture risk is yet to be established. Discussing this device with a healthcare provider is crucial to determine if it's suitable for your bone health needs.

Visit the official Osteoboost website for more information on the device and its indications.

Frequently Asked Questions

No, Osteoboost is not a pill, medication, or dietary supplement. It is a wearable medical device in the form of a belt that delivers vibration therapy.

FDA clearance is granted for medical devices that are demonstrated to be safe and effective for their intended use. FDA approval is a more stringent process reserved for new drugs, where the manufacturer must provide substantial evidence of both safety and efficacy from clinical trials.

Osteoboost's effectiveness is based on a randomized, sham-controlled clinical trial involving postmenopausal women with osteopenia. The study found that consistent use significantly reduced the decline in vertebral bone strength and density compared to the sham device.

No, the FDA clearance for Osteoboost is specifically for postmenopausal women diagnosed with osteopenia. It is not indicated for the treatment of osteoporosis.

The clinical study for Osteoboost demonstrated a reduction in the decline of bone strength and density, but it did not directly evaluate fracture risk. It is intended to slow bone loss, which is a risk factor for fractures.

In clinical trials, Osteoboost was found to have no serious adverse events related to the device. The most common side effects were mild and reversible, such as dizziness, back pain, or muscle weakness.

Yes, Osteoboost is a prescription-only medical device. You must obtain a prescription from a healthcare provider to use it.