Latest Medical Devices News

PainChek Limited has achieved a landmark FDA De Novo classification for its PainChek Adult App, positioning it as the first regulated medical device for pain assessment in the US aged care sector and opening a $100 million annual market opportunity.

Memphasys Limited has announced a pro-rata entitlement offer to raise approximately $1.12 million, issuing new shares at $0.003 each with free attaching options, aiming to fund the commercialisation of its Felix™ system and strengthen working capital.

Cryosite Limited has inked a deal to acquire a strategic freehold warehouse in Auburn, NSW, doubling its storage capacity and positioning itself for significant growth in clinical trial logistics.

Memphasys Limited has revised its FY25 financials to reflect a $1.12 million liability linked to uncertain compliance with R&D tax incentive rules, pending a private tax ruling.

EMVision Medical Devices has launched a Share Purchase Plan allowing shareholders to invest up to A$30,000 at $1.94 per share, sweetened by free-attaching options exercisable at $3.40 each.

Uscom Limited has struck a deal to sell its entire business to Singapore-based AXO Medtech VCC for $2.59 million, aiming to unlock capital for growth under new ownership. Shareholder approval is the next critical step before the transaction can proceed.

Orthocell has appointed its first Canadian distributor for Remplir, its innovative nerve repair device, ahead of an official launch at a major surgical conference in Vancouver. The move marks a significant step in expanding the product’s international footprint.

Anteris Technologies has gained shareholder approval for an ASX waiver allowing flexible capital raising and updated its PARADIGM trial timeline, now set to begin patient enrolment in Q4 2025 after addressing FDA requests.

CurveBeam AI Limited has secured A$6.5 million in new capital to fuel global growth of its HiRise™ weight-bearing CT scanner, deepen its partnership with orthopaedic giant Stryker, and advance a potential strategic deal in China.

CurveBeam AI has secured A$6.5 million through an institutional placement and completed a €10 million vendor financing facility to accelerate sales of its HiRise™ CT scanner. The company is also progressing a strategic partnership in China and advancing surgical robot validation.

Uscom Limited’s shares have been suspended from trading on the ASX due to concerns over its financial health, following a critical auditor’s disclaimer. The suspension will remain until the company meets regulatory requirements.

EMVision Medical Devices launches a $2 million Share Purchase Plan offering shares at a 16.4% discount, bundled with free options exercisable at $3.40, aiming to bolster clinical and commercial milestones.