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Graphene-Based Devices Face Regulation Questions In Europe

 
• By Barnaby Pickering

Medtech Insight spoke to two CEOs of start-ups working on graphene-based devices to learn more about how regulation and fears over nanomaterials’ side effects affect device development.

• Source: Alamy

New companies have been attempting to exploit graphene’s properties for medtech because it offers unrivalled conductivity at body temperature, flexibility, and most importantly, biocompatibility.

Since first being isolated by professors Andre Geim and Kostya Novoselov in 2004 at the University of Manchester, graphene has...

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More from Diagnostics

Harbinger Health Showcases Two-Tiered MCED Test With Strong Specificity And Per-Cancer Accuracy

 
• By Shubham Singh

With a test platform designed to mirror the biological diversity of cancer, Harbinger Health is moving beyond traditional performance measures to introduce cancer-specific sensitivity and “intrinsic accuracy” as cornerstones of its clinical narrative.

Veterinary Heart Health Goes High-Tech: Eko And Boehringer Use AI To Spot Heart Murmurs In Dogs

 
• By Marion Webb

Eko hopes its new partnership with Boehringer Ingelheim to develop algorithms for accurately detecting heart murmurs in dogs will pave the way for more collaborations with medical and pharmaceutical companies to advance early detection in humans as well as animals.

Prix Galien Spotlights Mental Health ‘Renaissance’ But Systemic Hurdles Persist

 
• By Natasha Barrow

Experts at the Prix Galien UK Forum discussed the future of mental health innovation, emphasizing the important roles of digital solutions, diagnostic biomarkers and community involvement.

With LDT Rule DOA, Could FDA Shift Focus To RUOs?

 
• By Brian Bossetta

Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?

More from Device Area

A Year After Exiting The Ventilator Market, Medtronic Recalls Thousands Of Newport Devices

 
• By Brian Bossetta

After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.

FDA Drops Package Labeling Guidance For Hernia Mesh Manufacturers

 
• By Brian Bossetta

The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.

Medtech Innovators Court London-Based Investors At BioWales 2025

 
• By Ashley Yeo

BioWales in London 2025 showcased the efforts healthtech innovators are making to meet investors on their own turf, illustrating changing attitudes and evolving needs.