People use apps and smart devices from big tech companies every day, but have you ever wondered what these giants have accomplished in the medical field? How many medical devices from big tech have actually received FDA approval?
Let's explore the surprising extent of their healthcare innovation.
Apple: Leading the Consumer Health Revolution
Apple stands out as one of the most active players in securing FDA approvals for consumer health devices. The company has achieved an impressive regulatory track record with three De Novo approvals and eight 510(K) clearances.
Apple made history in 2018 with the ECG App, becoming the first company to receive FDA approval in this category. The FDA even created a new product code (QDA) specifically for this innovation, which has since been used as a predicate by competitors like Fitbit and Samsung.
That same year, Apple secured another groundbreaking De Novo approval for the Irregular Rhythm Notification Feature in Apple Watch. Once again, the FDA established a new product code (QDB) for this category, highlighting the novel nature of Apple's approach to consumer health monitoring.
Fitbit (Google): Building on a Decade of FDA Experience
Fitbit has been working with the FDA since 2013, demonstrating a long-term commitment to regulatory compliance. In 2014, they achieved their first 510(K) clearance for the Aria Wifi Smart Scale.
A significant milestone came in 2023 when Fitbit received their first De Novo approval for Body Temperature Software (BTS). Notably, they remain the only company operating under product code QZA, indicating their unique position in this specific category of health monitoring.
Amazon: Pandemic Response through STS Lab Holdco
Amazon's FDA involvement took a different path, focusing on pandemic response. In 2021, the company obtained four Emergency Use Authorization (EUA) devices through its STS Lab Holdco subsidiary. All four approvals were specifically for SARS-CoV-2 testing, demonstrating Amazon's rapid pivot to address urgent public health needs during the COVID-19 pandemic.
Microsoft: Software-focused Healthcare Solutions
Microsoft's approach differs significantly from other big tech companies, concentrating on software rather than hardware solutions. The company has secured two 510(K) clearances for radiological image processing, one in 2017 and another in 2012. Both approvals fall under product code LLZ, reflecting Microsoft's expertise in medical imaging software.
This software-centric strategy aligns with Microsoft's broader business model and showcases how different tech giants leverage their core competencies in the healthcare space.
The Bigger Picture
The regulatory journey of these tech giants reveals distinct strategies: Apple focuses on consumer wearables and direct health monitoring, Fitbit emphasizes comprehensive wellness tracking, Amazon leveraged its logistics capabilities for pandemic testing, and Microsoft applies its software expertise to medical imaging.
As healthcare continues to digitize, these FDA approvals represent just the beginning of big tech's transformation of medical care and health monitoring.