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In October 2022, the FDA launched the "Total Product Life Cycle Advisory Program (TAP)" pilot to accelerate the development of innovative medical devices and technologies critical to public health. TAP facilitates "early, frequent, and strategic communication" with the FDA to enhance collaboration with manufacturers and third parties, speeding up patient access to innovative medical devices.
The European Society of Cardiology and the European Association of Percutaneous Cardiovascular Interventions issued a consensus statement in March 2023 stating that renal sympathetic denervation can be used as adjunctive therapy for patients with uncontrolled hypertension who have had inadequate responses to medications and lifestyle changes.
In 2013, Stryker acquired Mako Surgical and has since maintained a leading position in the robotics field. In 2019, Zimmer Biomet's Rosa knee system received 510(k) clearance, entering the market. J&J took longer to enter the market, with its Velys product first receiving FDA clearance in 2021. Recently, the company has expanded the system's scope of use.
Truist analyst Richard Newitter indicates that feedback from the Heart Rhythm Society (HRS) meeting suggests 50% to 70% of doctors will "immediately" adopt the technology.
An increasing number of medical devices are incorporating artificial intelligence or machine learning (AI/ML) functionalities. The FDA updated its list of AI/ML-enabled devices on May 13, 2024, adding 191 newly approved devices, bringing the total to 882.
