Latest Medical Devices News

Imricor Medical Systems has reached a crucial milestone as the FDA accepts and closes the manufacturing module of its Premarket Approval submission, advancing its MR-guided electrophysiology devices closer to US market entry.

CurveBeam AI has secured over A$600,000 through its Share Purchase Plan, bolstering funds alongside a recent A$5 million placement. The capital will fuel the China launch and product development for its HiRise™ CT scanner.

EMVision has accelerated recruitment in its pivotal emu™ brain scanner trial, surpassing 200 patients and advancing FDA discussions to broaden clinical endpoints, setting the stage for regulatory submission in early 2027.

Ceretas Limited posted a $1.63 million net loss for FY26 on $1.28 million revenue from government grants, advancing its clinical-stage Alzheimer’s ultrasound platform. The company completed an $8 million IPO in July to fund pivotal trials and device development.

Vectus Biosystems has reported a striking turnaround with a $1.56 million profit for the 2026 financial year, reversing a prior year loss and improving its balance sheet significantly.

OncoSil Medical lifted revenues 44% in FY26 to $1.68 million and trimmed losses by 28% to $10.86 million, buoyed by key regulatory approvals including FDA HDE and Australian TGA listings. The company is poised for commercial launches in the US and Australia, with strong clinical data underpinning its growth.

CurveBeam AI has secured nearly half of its A$5 million placement at $0.02 per share, issuing 120 million shares to key investors while awaiting the remainder of funds from Intellivision Holdings.

SomnoMed reported a 3% revenue rise to $114.5 million and a 19% EBITDA increase to $10.9 million in FY26, navigating European market headwinds and a CEO transition while launching its Virtus device targeting sleep apnea with bruxism.

Saluda Medical delivered FY26 revenue of US$90.2 million, beating guidance with strong US and international growth, while reporting a flat net loss of US$149.6 million amid ongoing heavy investment. The company’s FDA approval of its CAP24 paddle lead opens a new US surgical market segment.

Imricor Medical Systems and Philips have launched a combined interventional MR lab solution integrating Philips’ 1.5T BlueSeal MRI with Imricor’s MR-compatible systems, targeting cardiac electrophysiology and setting a new standard for MR-guided interventions.

Epiminder Limited reported a $42.7 million loss for FY26, driven by clinical trial and product development costs following a $125 million IPO. The company progresses its FDA-approved Minder implantable EEG monitor with a pivotal US trial and next-gen device on track for 2028 launch.

PolyNovo reported a 16.1% rise in FY26 revenue to AUD 150 million, driven by strong global sales and manufacturing expansion, yet net profit fell 44% due to a significant asset write-off from an R&D centre fire and lower tax benefits.