Mainstay Medical Holdings plc has won U.S. FDA approval for its Reactiv8 implantable neurostimulation device. The company is eyeing a commercial launch of the system in early 2021. The FDA approved Reactiv8 as an aid in managing intractable chronic low back pain associated with multifidus muscle dysfunction in adults who have failed therapy and are not candidates for spine surgery.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is pushing back implementation dates for numerous medical device reforms due to delays caused by the COVID-19 pandemic.

Smart assisted surgery company Naviswiss AG, of Brugg, Switzerland, has gained U.S. FDA clearance for its miniature navigation technology for hip replacement surgery. The hand-held system, with an open platform that supports all implant vendors, is being offered on a fee per-use basis.

LONDON – Sirakoss Ltd. has received FDA 510(k) clearance for its nanoparticle synthetic bone graft substitute, after showing the ready-to-use putty is equivalent to the CE-approved dry formulation. Rather than granules that are mixed with a patient’s blood before administration, the inorganic calcium phosphate-based Osteo³ Zp putty consists of the granules suspended in a fully synthetic resorbable carrier.