PodParley PodParley
PodParley
EP223-WHOOP手環"血壓洞察"風波，到底是健康產品還是醫療器材? episode artwork

EPISODE · Aug 10, 2025 · 42 MIN

EP223-WHOOP手環"血壓洞察"風波，到底是健康產品還是醫療器材?

from 生醫人生旅歷 · host BioMeder

這集我們來看一則上個月出現在新聞上的案例。 US FDA對一間穿戴式科技產品的公司WHOOP發出警告信，原因是FDA認為WHOOP推出的Blood Pressure Insights(BPI,血壓洞察)功能，屬於醫療器材，應該要向FDA申請許可或批准才可以上市。Whoop在隔天隨即在網路上公開反擊，堅稱BPI是健康產品，不是醫療器材... 不得不說這樣的狀況真的很多.. 到底是不是"醫療器材"，還是要回歸產品的本質來討論。 然而你的行銷用語和產品設計，會直接影響這個產品的應用面和消費者的直覺感受.. 如果被認定是醫療器材，有免責聲明也沒用喔! FDA警告信: WHOOP, Inc. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/whoop-inc-709755-07142025 WHOOP公開回應:Why WHOOP Stands Behind Blood Pressure Insights https://www.whoop.com/us/en/thelocker/why-whoop-stands-behind-blood-pressure-insights/ 留言告訴我你對這一集的想法： https://open.firstory.me/user/ckssiau1vq5ic082295g8on9d/comments ✎ 留言: podcast.biomeder.com/contact-us 📧 Email: [email protected] 《生醫人生旅歷》podcast.biomeder.com   《BioMeder生醫人網摘》biomeder.com Powered by Firstory Hosting

Episode metadata supplied by the publisher feed · Published Aug 10, 2025

Embed this episode

Ready to play

EP223-WHOOP手環"血壓洞察"風波，到底是健康產品還是醫療器材?

0:00 42:31

No transcript for this episode yet

We transcribe on demand. Request one and we'll notify you when it's ready — usually under 10 minutes.

Share this episode

Similar Episodes

No similar episodes found.

Similar Podcasts

Crypto Education Cypher Funk Elevate your crypto game with the University's Audio Channel! Enjoy free education that uncovers the secrets of blockchain and investment strategies. Perfect for all levels – unlock your potential in the crypto world now!__00___¡Eleva tu juego cripto con el Canal de Audio de la Universidad! Disfruta de educación gratuita que revela los secretos de la cadena de bloques y las estrategias de inversión. Perfecto para todos los niveles – ¡desbloquea tu potencial en el mundo cripto ahora!__00___提升你的加密游戏，加入大学音频频道！享受免费教育，揭示区块链的秘密和投资策略。适合所有水平的人士——现在就在加密世界中释放你的潜力吧！ Albert英语研习社 Albert英语研习社 欢迎关注微信公众号「Albert英语研习社」获取节目文本和更多原创英语学习内容。 关于Albert ●没有名牌大学背景，没有英语专业背景 ●没有国外留学经历，没有英语生活环境 ●22岁成为500强公司英文讲师，录音素材全球员工使用 ●24岁自学成为同声传译 ●25岁为瑞士总统翻译

Frequently Asked Questions

How long is this episode of 生醫人生旅歷?

This episode is 42 minutes long.

When was this 生醫人生旅歷 episode published?

This episode was published on August 10, 2025.

Can I download this 生醫人生旅歷 episode?

Yes. Use the download control on the episode player to save the publisher-provided media file.
URL copied to clipboard!