Latest Medical Devices News

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

OncoSil Medical reported a 60% year-on-year increase in dose sales in Q3 FY26, boosted by expanding treatment centres and advancing clinical trials, while cost-cutting and a new manufacturing facility aim to underpin growth.

Orthocell’s latest Remplir™ Real World Evidence study reveals an 89.7% treatment success rate across 78 nerve repair procedures, reinforcing its clinical strength and fueling US and European market growth plans.

Imricor Medical Systems advanced FDA clearances and expanded clinical trials in Q1 CY26, positioning for commercial growth despite higher operating cash outflows.

Vitrafy Life Sciences completed Phase II of its U.S. Military platelet cryopreservation study with strong results for a simplified no-wash process, accelerating commercial interest and progressing FDA device registration despite manufacturing delays.

TruScreen Group has met its FY2026 revenue guidance with a 41% jump in product sales, while investing heavily in new markets and pursuing a major UNITAID funding bid that could reshape its medium-term outlook.

Imricor Medical Systems updates its SEC Form 10 with minor SEC-driven revisions as it pushes forward with FDA clearances and clinical trials, reporting a $25.3 million net loss in 2025 amid early-stage commercialisation.

EBR Systems secures Priority Review from Australia's TGA for its wireless cardiac pacing system, fast-tracking regulatory approval and expanding access for heart failure patients. This follows strong US commercial momentum after FDA approval.

Compumedics maintains robust sales momentum but faces FY26 revenue timing challenges due to MEG installation delays and a cautious Somfit D rollout. The company expects solid year-on-year growth and positions for improved execution in FY27.

Orthocell’s Q1 FY26 revenue hits $3.2 million, buoyed by growing US sales of its Remplir nerve repair device and a robust $48 million cash position supporting global expansion.

Orthocell has swiftly converted regulatory approval into clinical use with the first Remplir™ surgery completed in a US Department of Defense hospital, marking a key step in its US commercial expansion.

BlinkLab has secured A$17.5 million through an oversubscribed placement to fuel regulatory trials and commercial launch of its AI-driven autism and ADHD diagnostic tools.