Latest Medical Technology News

PolyNovo delivered 16.1% revenue growth and a sharp improvement in operating cash flow in FY26, despite a lower statutory profit after a prior-year tax benefit and a fire-related write-off. The ASX-listed wound-care company now expects to lodge its U.S. PMA application for NovoSorb BTM before the end of 2026.

CurveBeam AI has secured FDA 510(k) clearance for CT-based bone mineral density measurement, establishing the first regulatory step towards a potential new SaaS offering. The more commercially significant HiRise weight-bearing application still requires a separate clearance.

Cleo Diagnostics has appointed Bio-Techne’s CLIA-certified U.S. laboratory Asuragen to run pivotal clinical validation for its pre-surgical ovarian cancer test. The approximately 1,470-sample program is intended to generate the evidence supporting a planned FDA 510(k) submission in the first half of calendar 2027.

Optiscan Imaging has reached an 84-case milestone in its live digital pathology study with Australian Clinical Labs, testing the InForm platform across a broad range of tissue types and disease settings. The data may support future regulatory submissions and commercial discussions, but the announcement does not disclose diagnostic accuracy metrics or regulatory approval.

Clever Culture Systems secures a follow-up order from Novo Nordisk for two APAS Independence instruments, marking a critical step toward broader global deployment and signalling expected sales growth from FY27.

Optiscan Imaging has launched a 35-patient clinical trial in the US to test its InVue™ and InForm™ platforms in head and neck cancer surgery, aiming to bolster its FDA submissions later this year.

Osteopore Limited’s half-year results show an 8% revenue drop driven by currency effects, while losses widen 14% as the company invests heavily in product development and market growth.

CurveBeam AI’s FY2026 results show a 28% revenue decline and a 12% increase in net loss, while advancing its China commercialisation and robotic surgery integration strategies. The company also announced a $6-7 million capital raise post-year-end.

Nexsen Limited (ASX:NXN) reported a 30% rise in net loss to $6.55 million for FY26, driven by ongoing investment in its Group B Streptococcus rapid diagnostic and Asia-Pacific growth initiatives following its October 2025 IPO.

HITIQ Limited posted a 21% drop in revenue to $1.59 million and reduced its net loss by 15% to $6.1 million for FY26, advancing commercialisation of its concussion management platform PROTEQT™ despite ongoing funding pressures and regulatory hurdles.

4DMedical’s CT:VQ™ lung imaging technology secured FDA clearance and CMS reimbursement, driving rapid adoption in top US medical centres and expanding its addressable market to $3 billion with new clinical programs and European contracts.

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.