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Medical Devices DECODED

Latest edition: 21 May 2024
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Spotlight

RQM+ launches AI module to enhance MedTech regulatory documentation

The Fern.ai Smart Authoring module automates and streamlines the management, and maintenance of documents.

Latest news

Final report says UK infected blood scandal “should have been avoided”

Nearly 30,000 people, including children in clinical trials, were infected with hepatitis C and HIV from contaminated blood products in the 1970s and 1980s.

Class I recall of Abbott's HeartMate 3 system may be dire for patients with heart failure

A promising alternative to the device is Jarvik Heart's Jarvik 2000 system.

Shoulder Innovations launches InSet 95 to enhance surgery outcomes

The implant is intended to provide superior rotational control and stability while allowing for precise implant alignment.

Laborie launches Solar Compact System and manometry catheter

The Solar Catheter is intended to improve the diagnosis of defecatory disorders and pelvic-floor dysfunctions.

The state of cybersecurity: AI and geopolitics mean a bigger threat than ever

Cybersecurity threats to businesses are not only more numerous than ever but are now becoming more sophisticated through the use of artificial intelligence (AI) by perpetrators and more dangerous in their use for geopolitical aims.

DentalMonitoring gains De Novo approval for orthodontic solution

The approval allows orthodontists to utilise the DentalMonitoring software to enhance clinical care.

Regulated mHealth Apps

Analyze the core components of the mobile health value chain.

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