Medical Device stories

i-GENTIC unveils context-aware AI agents to spot contradictions in FDA 510(k) files, aiming to cut rework and speed device clearances.

Pure Global launches flat-fee device approval model from $2,000 a year, bundling AI-assisted registration and post-market support.

RFiD Discovery’s GPS lockbox halts losses of BodyGuard T infusion pumps, saving NHS trusts over GBP £100,000 and easing discharge delays.

Flok Health has expanded its app-based digital physiotherapy service to 11 NHS areas in England, covering more than 2.4 million patients.

Shark Beauty’s award-winning CryoGlow cooling LED under-eye mask is set to launch in Australia and New Zealand, with a waitlist now open.

QHeart will begin a first-in-human trial of its pumpless Transcatheter Aortic Recoil Repair heart failure device in Australia in 2026.

A Copenhagen startup says its Argus software can generate full eye prescriptions from a single smartphone photo in under a minute.

An AI-powered physio app delivering same-day back pain care has been shortlisted for three national HSJ awards after slashing waits.

Compumedics secures AUD $4.2m MEG order from Shandong Normal University in China, lifting total contracted MEG orders to about AUD $30m.

As IoT devices surge, SonicWall firewalls step in to secure sprawling connected networks without slowing performance or innovation.

AI-fuelled attacks are pushing boards to ditch perimeter defences for real-time cyber risk visibility, reshaping security strategies by 2026.

Healthcare organisations face rising cyber threats, prompting greater reliance on MSSPs for 24/7 defence and rapid response to protect patient data and operations.

Claroty launches AI-powered CPS Library, a centralised asset catalogue enhancing visibility and vulnerability detection across OT, IoT, and healthcare networks.

Australia's DermR Health pioneers a needle-free skin cancer test, driven by purpose and bootstrapped funding, defying medtech's investor-driven challenges.

Borderless CS has launched managed cybersecurity services for healthcare, offering 24/7 threat monitoring and compliance support to protect patient data and systems.

Australis Scientific wins MedTech Innovator Asia Pacific Grand Prize and USD $175,000 for ConfidanzTM, a wearable device treating overactive bladder at home.

Manufacturers are boosting quality and efficiency by switching to single-controller systems that streamline complex production and data integration challenges.

LG Electronics Australia unveils advanced medical-grade displays designed to enhance accuracy and efficiency across diagnostic, surgical, and clinical healthcare settings.

Nearly all Canadian healthcare IT leaders rely on legacy systems, raising risks of security breaches and operational disruptions in patient care.

DeepHealth secures FDA clearance for TechLive, a remote scanning system now supporting ultrasound, enhancing efficiency amid rising radiology workloads.