The market is dominated by major medical device manufacturers, and we expect them to remain so in the near term. From August 1995 to August 2024, GE Healthcare, Siemens Healthineers, Canon Medical Systems, Philips Healthcare and Aidoc Medical received the most FDA AI/ML device approvals. Although these companies have always dominated the market, the updated list shows that these five companies received approximately 22% of all approvals during this period, compared to almost 30% in the previous list published in May 2024, highlighting the rapid pace of innovation in the medical device sector. However, we still expect companies with high approval ratings to maintain their market dominance, as they continue to announce strategies to enhance their AI portfolios through partnerships and launches of products. For example, on October 21, 2024, GE Healthcare announced the creation of a new AI Innovation Lab, an initiative designed to accelerate early AI innovation concepts, building on the company’s broader strategy. company in AI and digital. Siemens Healthineers has launched a series of AI-based diagnostic tools throughout 2024, including cardiology applications with AI for Acuson Sequoia an ultrasound system and a new 4D transesophageal transducer for cardiology exams announced in May 2024. Likewise, at the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting (October 27-30), Philips will present its latest imaging systems based on AI and its integrated cardiology solutions. In 2024, it invested in AI R&D, unveiling an AI-based diagnostic suite. Aidoc Medical has expanded its portfolio with leading hospitals and research institutes. In September 2024, Aidoc received four approvals for its AI software, standardizing cardiovascular and neurological assessments.
Multinational device makers will continue to dominate U.S. AI/ML approvals, but new regulations could delay market entry
