Latest Medical Device Innovation News

TruScreen Group Limited has successfully raised NZ$2.35 million through a share placement, attracting new institutional investors from Asia, while launching a discounted share purchase plan for existing shareholders.

ReNerve Limited has gained marketing approval for its NervAlign® Nerve Cuff™ in Bahrain, marking its first regulatory success in the Middle East and opening access to a rapidly expanding regional market.

EBR Systems has raised A$55.9 million through a fully underwritten placement to fund the commercial rollout of its FDA-approved wireless cardiac pacing system, with plans for a limited market release in H2 2025 and expanded distribution in 2026.

EBR Systems has won FDA approval for its pioneering leadless WiSE CRT System, setting the stage for a phased US commercial rollout. The company also secured key Medicare reimbursement pathways and expanded manufacturing capacity, though financial sustainability remains a concern.

Gyder Surgical, backed by Hydrix Ventures, has secured FDA 510(k) clearance for its innovative GYDER Hip System, opening the door to the lucrative U.S. market and increasing Hydrix’s investment value.

Micro-X Limited has requested an immediate voluntary suspension of its shares on the ASX, pending a forthcoming equity raising announcement expected by February 10.

Respiri Limited reports a standout December quarter marked by a 67% surge in patient program enrolments and robust revenue growth, bolstered by strategic acquisition synergies from Orb Health. The company is poised for further expansion in 2025 amid promising contract negotiations and evolving US healthcare reimbursement policies.