SpineGuard: Taming Of The Screw
Much of the innovation in spine over the past decade has aimed at replacing fusion, the standard of care. SpineGuard’s novel sensor technology is betting on fusion’s long-term prospects, helping patients and surgeons by making the procedure safer.
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Spine surgery has gone from the pariah of the orthopedic industry to that sector's fastest growing segment. Large companies have looked to capitalize on spine's rapid growth by acquiring their way into this space, a pattern of consolidation that has left the industry without a major pure play spinal company. SpineVision is looking to fill that void by developing a complete line of spinal products, starting with innovations on core technology, rather than relying on a typical start-up strategy of focusing on a particular device or clinical niche. The company's strategy will bring it immediately into competition with the market leaders' well-established product lines. But SpineVision is counting on experienced management and the current frustration among spine surgeons resulting from recent industry consolidation to attract physicians' attention.
“Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFl isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.
Publication of "ACNU" proposed rule wasn’t reached in straight line and featured coining another term with more of a regulatory sound, “NSURE,” and detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.