The FDA’s Breakthrough Devices Program continues to spotlight innovations that promise to transform patient care. Here are some standout devices recently granted breakthrough status that on enhancing patient outcomes through precision, personalization, and minimally invasive approaches.
- Defender™ Meniscus Implant – OrthoPreserve
OrthoPreserve’s Defender™ implant has received both FDA Breakthrough Device Designation and enrollment in the Total Product Life Cycle Advisory Program (TAP). This meniscus replacement device aims to address the approximately 250,000 Americans annually who experience persistent knee pain after meniscus surgery. Unlike traditional partial meniscectomy, which removes damaged tissue, Defender™ seeks to offer a durable, minimally invasive solution, potentially reducing the need for future surgeries and delaying the onset of degenerative arthritis.
- CERTA™ Access System – Obvius Robotics
Obvius Robotics’ CERTA™ Access System has been designated as a breakthrough device for central venous catheterization procedures. This robotic-assisted system aims to enhance the precision and safety of catheter placements, which are critical for administering medications and monitoring patients. By improving accuracy, CERTA™ seeks to reduce complication rates associated with these procedures.
- RESTORE™ Neuromuscular Interface System – Blue Arbor Technologies
Blue Arbor Technologies’ RESTORE™ system offers a direct interface between prosthetic limbs and residual muscles, enabling more natural and precise control. Unlike traditional surface electrodes, RESTORE™ connects directly to peripheral nerves, allowing for independent movement of joints such as fingers, wrists, and elbows. Early trials have demonstrated consistent motor signal capture over five years, providing hope for improved prosthetic integration and functionality.
- Eyemate™ Glaucoma Monitoring System – Implandata Ophthalmic Products
Implandata’s Eyemate™ system is an implantable micro-sensor designed for continuous intraocular pressure monitoring in glaucoma patients. This device enables real-time data collection, allowing for timely adjustments in treatment plans and potentially reducing the risk of vision loss associated with glaucoma.
- Rheumatoid Arthritis Neuromodulation Device – Nēsos
Nēsos has developed a prescription digital therapeutic device that utilizes electrical signals delivered through earbuds to modulate neurological pathways. This approach aims to rewire the immune system, potentially reducing the severity of rheumatoid arthritis symptoms and offering a non-pharmacological treatment option for patients.