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2024 年，多项重要活动和政策已经并将影响医疗器械开发领域。随着监管程序的简化，在 FDA 加速审批流程和医疗器械开发工具 (MDDT) 计划的帮助下，一个快速创新的新时代已经到来，尤其是在支持人工智能的设备和先进的成像技术方面。例如，FDA 的医疗器械开发工具 (MDDT) 计划通过纳入Apple Watch 的心房颤动 (AFib) 历史记录功能标志着一个重要里程碑。这是“数字健康技术”领域首次获得此类认证，它使 Apple Watch 能够为临床研究贡献宝贵的数据。

Several important activities and policies have and will influence the medical device development scene in 2024. A new era of rapid innovation, notably in AI-enabled devices and advanced imaging technologies, has been ushered in with the streamlining of regulatory procedures, aided by the FDA's accelerated approval processes and the Medical Device Development Tools (MDDT) program. For instance, the FDA's Medical Device Development Tools (MDDT) program marked a significant milestone with the inclusion of Apple Watch's atrial fibrillation (AFib) history feature. This qualification, a first of its kind for "digital health technology’, enables the Apple Watch to contribute invaluable data to clinical studies.

AdvaMed的政策议程继续强调强大的供应链和立法支持（如VALID 法案）对于保证精确诊断测试的重要性。此外，AdvaMed 通过提供研究资金和优惠税法来促进初创企业和小型企业的发展，从而推动行业创新。尽管存在宏观经济问题，但美国、中国和日本仍在行业增长方面处于领先地位。确保公平获得创新医疗技术和促进临床试验多样性的举措进一步加强了这一增长。

The policy agenda of AdvaMed continues to spotlight the significance of a robust supply chain and legislative support, like the VALID Act, in guaranteeing precise diagnostic tests. Additionally, AdvaMed promotes startups and small enterprises by providing money for research and advantageous tax laws, which advances industry innovation. The US, China, and Japan are leading the way in industry growth despite macroeconomic problems. This growth is strengthened by initiatives to ensure fair access to innovative medical technology and to promote diversity in clinical trials.

除了监管改革外，新政策还通过增加资金和公私合作来加强创新。美国政府已拨出大量资金和补助金来支持医疗器械行业的研发。生物医学高级研究与发展局 (BARDA) 和美国国立卫生研究院 (NIH) 等计划为早期创新提供了极大帮助。

Beyond regulatory reforms, new policies are strengthening innovation through increased funding and public-private collaborations. The US government has allocated significant funds and grants to support research and development within the medical device industry. Early-stage innovation is greatly aided by initiatives like the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health (NIH).

此外，政府机构、学术机构和私营公司之间的合作也越来越普遍。医疗器械市场预计将进一步发展，这表明在不断变化的医疗环境中迫切需要灵活的规则。这有几个令人信服的原因，包括患有慢性病的人数不断增加、人口老龄化以及对微创手术的需求不断增长。

Moreover, collaborations between government agencies, academic institutions, and private companies are becoming increasingly common. The medical device market is expected to develop even more, which indicates that flexible rules are desperately needed in the ever-changing healthcare environment. This is backed by several compelling reasons, including the growing number of people with chronic conditions, the ageing population, and the growing need for minimally invasive operations.

新冠肺炎疫情表明，只要制定正确的规则，医疗行业就能迅速发展，这也严肃地提醒我们强大医疗体系的重要性。

The COVID-19 pandemic showed that, with the right rules in place, the healthcare industry can develop swiftly and serve as a grim reminder of the importance of strong healthcare systems.

在立法者试图创建适应性强的法律结构的同时，美国通过优先改善患者治疗效果并降低医疗成本，成为医疗创新领域的领导者。该行业的预期增长取决于持续的立法支持，凸显了其在塑造医疗保健未来方面的关键作用。

While legislators try to create adaptable legal structures, the US becomes a leader in medical innovation by prioritising improving patient outcomes while reducing healthcare costs. The industry's anticipated growth is contingent upon continued legislative support, highlighting its critical role in shaping the future of healthcare.

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