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Medical Devices Excluded From EU Cyber Resilience Act Proposals

 
• By Eliza Slawther

Medtech companies will avoid the need to comply with yet another EU regulation, it seems, after the European Commission confirmed that proposals to tighten up cybersecurity rules for internet-connected products will not apply to medical devices.

DARK HACKER
• Source: Shutterstock

Proposals for the European Commission’s Cyber Resilience Act (CRA) were firmed up on 15 September. The legislation sets out plans to introduce EU-wide common cybersecurity rules for manufacturers and developers of products with digital elements - covering a vast range of devices, from children’s toys to household appliances.

The CRA will mandate certain strict requirements around cybersecurity for manufacturers of products that can connect to the internet and which apply throughout the product life cycle. For instance, the...

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• By Natasha Barrow

Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.

Data Finds Capillary Blood Is A Reliable Alternative To Venous Blood For Routine Testing

 
• By Natasha Barrow

A study from Babson Diagnostics published in the peer-reviewed Journal of Applied Laboratory Medicine showed that capillary blood sample volume issues can overcome historical challenges, such as poor quality, through a technique called assay miniaturization.

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.