MedCloud Minute
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The U.S. Food and Drug Administration has granted breakthrough device designation to SpinaFX Medical’s Triojection system, a minimally invasive treatment for contained lumbar disc herniations, the Canadian company said on Wednesday.
The image-guided procedure uses a proprietary oxygen-ozone delivery system inserted into the spinal disc to reduce pressure and relieve nerve compression. The treatment can be performed on an outpatient basis in hospitals, ambulatory surgical centers, or clinics with minimal infrastructure, SpinaFX said.
The designation gives developers prioritized access to the FDA for feedback and review, aimed at accelerating regulatory clearance for devices addressing serious conditions.
SpinaFX said Triojection is intended as a targeted alternative to conservative care or invasive surgery, offering potential benefits in safety, recovery time and cost. The company added that international studies support the technology, with further trial results expected.
Posted by MedCloudInsider Editors on 08/20/20250 comments
A new startup, BIOPAC Medical Systems LP, has launched following a licensing agreement between Johns Hopkins Applied Physics Laboratory, Johns Hopkins School of Medicine, and medical device firms to commercialize neural blockade monitoring technology. The device provides real-time, objective evaluation of regional anesthetic effectiveness during surgical procedures.
The technology was invented by former APL engineer Wayne Sternberger and pediatric anesthesiologist Dr. Robert Greenberg to address a critical gap in clinical care. Currently, clinicians lack reliable ways to evaluate nerve block effectiveness, particularly in vulnerable patients like children or those under general anesthesia.
"We're putting medical innovation into practice, transforming a pioneering concept into a potentially life-enhancing tool for clinical care," Sternberger said in a statement. The venture received support from Maryland's innovation initiative and a National Science Foundation grant, positioning it for regulatory approval and commercial deployment.
Posted by MedCloudInsider Editors on 08/20/20250 comments
NeuroOne Medical Technologies received FDA clearance for its OneRF ablation system to treat trigeminal neuralgia, a chronic facial pain condition affecting about 150,000 Americans annually. The minimally invasive device uses radiofrequency energy to create lesions that interrupt pain signals from the trigeminal nerve. The Eden Prairie, Minnesota-based company plans a limited launch in Q4 2024, marking its first expansion into chronic pain treatment beyond neurosurgery applications. CEO Dave Rosa said the company expects to pursue additional pain management opportunities, including lower back pain treatments, leveraging its technology platform.
Posted by MedCloudInsider Editors on 08/20/20250 comments