Latest Clinical Validation News

Singular Health Group has advanced its U.S. commercial footprint with the deployment of 500 new licences under its PNS contract and secured FDA clearance for its cloud-based 3DICOM MD® platform, positioning the company for significant growth.

Echo IQ has completed clinical validation of its EchoSolv HF heart failure detection software with the Mayo Clinic Platform, achieving outstanding accuracy. The company has now formally submitted its FDA 510(k) clearance application, positioning itself for significant commercial expansion in the US healthcare market.

Anteris Technologies Global Corp. has launched a $230 million equity offering alongside an $84 million private placement with Medtronic’s subsidiary, aiming to accelerate clinical trials and scale manufacturing of its innovative DurAVR Transcatheter Heart Valve.

Atomo Diagnostics has locked in exclusive global rights to a novel liver function test that rapidly detects liver injury, expanding its footprint in point-of-care diagnostics. The test, delivered on Atomo’s Pascal platform, targets drug-induced liver injury and chronic liver conditions with significant commercial potential.

Tetratherix has successfully completed the second safety review of its TetraDerm clinical trial's second cohort, showing no adverse events and confirming a strong safety profile. The trial now progresses to its final phase, targeting a growing reconstructive surgery market.

EBR Systems reported a doubling of WiSE System implants in Q4 FY2025 alongside the launch of key clinical studies and preliminary revenue guidance, signalling strong commercial and clinical momentum.

UC San Diego Health has begun clinical use of 4DMedical’s CT – VQ™, marking the fourth leading US academic medical centre to adopt this innovative lung imaging technology since FDA clearance. This milestone underscores 4DMedical’s rapid commercial traction and growing influence in respiratory diagnostics.

Nexsen Limited has initiated FDA engagement for its rapid Group B Streptococcus diagnostic sensor, aiming for expedited US market entry, while bolstering its leadership team and scientific credentials.

Biome Australia Limited has reported a record-breaking quarter and half-year sales performance, driven by strong demand for its clinically-backed probiotic products. Revenue surged over 40% compared to the previous year, defying typical seasonal slowdowns.

Memphasys has secured CE Mark approval for its Felix™ sperm selection system, enabling full commercial rollout across Europe and activating multi-year contracts worth over A$1.3 million. This milestone signals the company’s transition into a revenue-scaling phase with global growth ambitions.

Artrya Limited has signed a significant five-year commercial agreement with Cone Health, marking its third U.S. customer and solidifying its foothold in the American healthcare market with its AI-powered Salix platform.

Saluda Medical has received CE certification for its EVA™ Sensing Technology, enabling commercialisation in Europe and recognition in Australia following prior FDA approval. This milestone sets the stage for a broader rollout of its personalised spinal cord stimulation therapy in early 2026.