Daily Newsletter

27 September 2023

Daily Newsletter

27 September 2023

Edwards Lifesciences named as the manufacturer targeted by EU antitrust raid

Edwards Lifesciences has come forward as the cardiovascular device company at the centre of the European Commission investigation of potential antitrust violations.

Kiays Khalil September 27 2023

Edwards Lifesciences, has been identified as the company subject to unannounced raids by the EU commission on September 19th, 2023. 

The raid was conducted as part of an investigation into abuses and breaches of EU antitrust regulations, related to Article 102 of the Treaty on the Functioning of the European Union, which prohibits abuses of a dominant market position.  

In a statement on the Edwards Lifesciences website the company said: “Edwards Lifesciences is cooperating with the European Commission regarding its inspection in relation to EU competition law. We have an unwavering commitment to healthy, fair competition; when innovative companies like ours compete, patients benefit. We remain confident in our business practices and will not be commenting further at this time.” 

The original press release from the EU commission gave minor details of the operation and did not name the target of the investigation. The statement only alluded to the company being a specialist in medical devices for cardiovascular applications. 

If found guilty of violating EU antitrust rules Edwards Lifesciences could be fined as much as 10% of its global turnover. 

Reuters were the first to break the story and reported Edwards Lifesciences’ shares dipped 2.5% in pre-market trade after the news was released.  

Earlier in September, Edwards Lifesciences had the world's first patient in a clinical trial to test its device aimed at relieving symptoms of heart failure. 

In August 2023 the firm also received 510(k) clearance for the Smart Wedge Algorithm

According to a GlobalData report, global market value for cardiovascular devices will grow at a compound annual growth rate (CAGR) of 6% to $62 billion by 2025. 

Generative AI set to transform the medical devices industry

Generative AI can improve personalized healthcare by collecting data from patients via wearable devices, which can provide continuous, real-time data that can complement traditional data sources such as imaging, patient records, and more. It can also enhance existing imaging techniques by generating high-quality images of organs using data from low-resolution images (such as ultrasounds). However, the collection and use of patient healthcare data through AI medical products could conflict with regulations around the globe.

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