Latest Medical Technology News

Optiscan Imaging has lodged a US FDA 510(k) application for InVue, its precision surgery device designed to provide cellular-level imaging during operations. The submission moves the technology into formal regulatory review, but clearance and commercialisation remain uncertain.

Optiscan Imaging has lodged a 510(k) submission for its InForm digital pathology device, moving the product from development into formal US regulatory assessment. FDA clearance is not assured, but a successful determination could open the door to commercial distribution in the company’s target market.

CONNEQT Health delivered sharp FY26 revenue growth and reduced its statutory loss as Pulse sales and clinical subscriptions expanded. But the ASX-listed medtech group ended the year with negative net assets, heavy cash burn and a material uncertainty over its ability to continue as a going concern.

Compumedics Limited (ASX:CMP) returned to profit in FY26 as record revenue, stronger cash generation and a sharp rise in MEG and SaaS sales reshaped its earnings profile. The company enters FY27 with A$28.3 million of open orders, but lower gross margins and uneven US and European execution remain key tests.

4DMedical delivered sharp growth in scans, sites and operating revenue as CT:VQ moved into commercial deployment across several global markets. But the company remains loss-making and its auditor issued a qualified opinion over the carrying value of goodwill and other intangible assets.

Cleo Diagnostics has begun developing a multi-biomarker blood test for ovarian cancer screening in asymptomatic women, targeting a stated $150 billion global market. The prototype program will run alongside the company’s pre-surgical test, with initial proof-of-concept data expected early next quarter.

Micro-X has told ASX it is unaware of any undisclosed information explaining the sharp move in its shares, which rose from $0.030 to $0.045 during 23 September trading. The company pointed to elevated volumes, earlier institutional selling and chairman Patrick O’Brien’s purchase of 1.36 million shares.

BCAL Diagnostics has begun introducing ClearNote Health’s Avantect Multi-Cancer blood test in Australia, starting with Sydney and Melbourne. The test reported 56.2% sensitivity and 98.4% specificity in a case-control validation study, but the company says a negative result does not rule out cancer.

BluGlass has begun a three-to-five-month, A$286,000 feasibility collaboration with global photonics company Coherent to develop a novel gallium nitride device for scientific and medical applications. The agreement offers technical and commercial promise, but does not yet include a production commitment or confirmed product launch.

CurveBeam AI has raised A$1.75 million through an oversubscribed SPP shortfall offer and placement, lifting its recent capital raised to A$7.36 million. The funds will support the HiRise China launch, product development, supply-chain preparation and working capital.

Hydrix has secured a three-year contract with Singapore’s National Heart Centre to deploy the Implicity remote cardiac monitoring platform. The agreement is expected to generate about A$0.625 million, although the final value depends on patient volumes and implementation.

Ceretas has completed the third milestone of its government-backed CUREator+ program, unlocking a final $692,578 non-dilutive funding tranche. The work delivered functional prototypes of proprietary neuronavigation software and a lift assist device intended to simplify operation of its next-generation Alzheimer’s ultrasound system.