Shots:
The US FDA has granted 510(k) clearance to Saber-XA, an anterior lumbar interbody fusion (ALIF) system combining an expandable cage with a zero-profile anterior lumbar plate, enabling intra-operative customization of implant height & lordosis
Saber-XA allows surgeons to independently adjust implant height & lordotic angle based on patient anatomy, with multiple configurations across its…
Shots:
The US FDA has granted 510(k) clearance to Revi Extend, the next-generation implant for Revi System to treat urgency urinary incontinence (UUI), with the new implant offering an extended lifespan of 15yrs.Limited US launch planned for Q4’26
Built on Implantable Tibial Neuromodulation (ITNM), Revi System is designed to reduce the long-term treatment burden through…
Shots:
The US FDA has approved Encelto (revakinagene taroretcel-lwey) to treat macular telangiectasia type 2 (MacTel); commercially available in the US by Jun 2025
Approval was based on P-III trial data demonstrating reduced macular photoreceptor loss for ~24mos. post-implantation
Encelto (intravitreal implant) utilizes an encapsulated cell therapy tech to continuously deliver ciliary neurotrophic…

