Latest Medical Devices News

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.

Vitrafy has added US blood network Versiti to its cryopreservation development programme, with the partnership focused on no-wash platelet preservation and regulatory verification. The deal strengthens the company’s institutional network, but initially generates no revenue and remains subject to US regulatory requirements.

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.

Cochlear is defending a class action filed in the Supreme Court of Victoria over its FY26 underlying net profit forecast. The claim covers investors who acquired interests in Cochlear shares between 15 August 2025 and 21 April 2026.

EBR Systems has completed the FDA’s pre-approval inspection of its new Santa Clara manufacturing facility, receiving two Form 483 observations. The company says it expects to correct them in the fourth quarter and still anticipates approval by year-end, although the FDA has not yet made its final determination.

EMVision Medical Devices has received a $4.3 million R&D tax refund, adding non-dilutive funding as it progresses clinical work on its emu™ and First Responder devices. The cash arrives against a last reported cash balance of $17.1 million and $4.6 million in remaining grant funding at 30 June 2026.

Memphasys says it has identified a potential FDA 510(k) pathway for its Felix sperm separation system, replacing the more complex De Novo route previously contemplated. The company will seek FDA feedback before targeting a formal submission in the first quarter of 2027, while keeping commercial execution focused on existing markets.

ReNerve has converted regulatory approvals into its first commercial NervAlign Nerve Cuff surgeries in Hong Kong and Malaysia, expanding activity to seven jurisdictions. The milestones arrive as FY26 sales climbed 88% to $510,357 and the company builds out its US distribution network.

CMS has finalised higher Medicare inpatient reimbursement for EBR Systems’ WiSE System, lifting base payment rates by up to 93% from 1 October 2026. The change improves the commercial payment pathway, although its financial impact will depend on procedure volumes, hospital adoption and NTAP eligibility.

Orthocell has recorded the first commercial sales of its Remplir nerve repair product in Thailand, opening a new market estimated at US$84 million. The launch gives the company another distributor-led growth channel, although near-term sales are expected to remain modest.

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.

Epiminder has enrolled the 75th patient in its DETECT study, meeting its September target as the US site network expands to 21 centres. The company expects to reach 100 enrolments in November and remains focused on completing the 210-patient study by the end of the first half of calendar 2027.