Latest Heart Failure News

Echo IQ says it sees a path to US FDA clearance for EchoSolv HF after receiving a Not Substantially Equivalent determination. The company is weighing an appeal, an Ombudsman review or a fresh 510(k) submission, but has not selected a route or set a firm timetable.

EBR Systems’ new Santa Clara manufacturing facility has entered the FDA’s pre-approval inspection process, marking a key regulatory step for its wireless cardiac pacing business. The company continues to expect approval by the end of 2026, but the inspection does not yet amount to clearance.

ImpediMed reported a 15% revenue increase to $14.6 million in FY26, broadened reimbursement coverage for its SOZO platform to 95% of the US population, and launched new applications in heart health and weight management.

ImpediMed has secured FDA 510(k) clearance for its SOZO Digital Health Platform to assess sarcopenia risk, marking it as the only FDA-cleared bioimpedance spectroscopy solution for this clinical application. This clearance enables clinicians to non-invasively monitor muscle loss in cancer and chronic disease patients, potentially improving treatment outcomes.

Mesoblast has treated 350 patients in its pivotal Phase 3 trial for rexlemestrocel-L, targeting chronic low back pain linked to degenerative disc disease, setting the stage for top-line results in mid-2027.

Mesoblast delivered US$115 million in Ryoncil® revenue in its first full year post-FDA approval, while expanding clinical trials into adult indications and acquiring cutting-edge CAR technology to boost its cell therapy pipeline.

ImpediMed reported a 3% revenue increase to $3.6 million in Q4 FY26, bolstered by a $15.3 million capital raise and strategic leadership hires as it pushes growth in cancer survivorship, heart health, and weight management.

Echo IQ has locked in a strategic $20 million investment and US partnership with Pro Medicus, alongside a $110 million capital raise, positioning the company for accelerated commercial expansion of its AI-driven cardiovascular diagnostics in the US.

EBR Systems has launched the WiSE Coupler in the US, a new accessory designed to improve the implantation of its wireless cardiac pacing electrode. The device has FDA clearance and was piloted in 10 procedures, marking another step in the company’s US commercial expansion.

Mesoblast Limited’s Ryoncil® posted US$36 million in Q4 revenue, driving a full-year total of US$115 million, exceeding initial forecasts. The FDA-approved stem cell therapy for pediatric graft-versus-host disease shows robust uptake across US pediatric centres.

Mesoblast has received a Biologics License Application filing number from the FDA for rexlemestrocel-L, targeting life-threatening bleeding in end-stage heart failure patients with LVADs, advancing its regulatory journey with orphan drug and RMAT designations.

Echo IQ has raised approximately A$110 million through a heavily supported institutional placement to fund its US commercial rollout and speed up development of its AI-driven cardiovascular diagnostics.