MedCloud Minute

The MedCloud Minute blog is researched, fact-checked, edited and updated by the editors of MedCloudInsider.com, with writing assistance from AI. To submit your company's press release for consideration, contact [email protected].


FDA grants breakthrough device status to SpinaFX Medical’s Triojection system

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.

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Posted by MedCloudInsider Editors on 08/20/20250 comments


Johns Hopkins Spinout Launches to Monitor Pain Management in Real Time

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.

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Posted by MedCloudInsider Editors on 08/20/20250 comments


NeuroOne Wins FDA Clearance for Facial Pain Device

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


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