Apple Wins Legal Battle for Blood Oxygen Tracking on Smartwatch

## Overview Apple Inc. is a global technology leader renowned for its innovative hardware, software, and services. Headquartered in Cupertino, California, Apple designs, manufactures, and markets smartphones (iPhone), personal computers (Mac), tablets (iPad), smartwatches (Apple Watch), digital media players, and a suite of accessories and wearables[2]. The company also operates a vast ecosystem of services, including Apple Music, iCloud, Apple Pay, and the App Store, which collectively form a significant and growing portion of its revenue[3]. ## History and Key Achievements Apple was founded in 1976 by Steve Jobs and Steve Wozniak, quickly making history with the Apple II, one of the first mass-produced personal computers[2]. The company pioneered the graphical user interface (GUI) with the Macintosh in 1984, setting new standards for user experience. After a period of decline, Apple’s resurgence in the late 1990s and 2000s was marked by groundbreaking products like the iPod (2001), iPhone (2007), and iPad (2010), which redefined entire industries. Apple’s integration of hardware, software, and services created a seamless ecosystem that fostered customer loyalty and drove industry transformation[2]. Apple became the first publicly traded U.S. company to reach a $1 trillion valuation in 2018, a milestone reflecting its dominant market position[1]. The company’s emphasis on design, privacy, and user experience has consistently set it apart from competitors. ## Current Status As of October 2025, Apple is valued at over $4 trillion, with annual revenue exceeding $400 billion and a share price around $270[1][2]. Despite a record year for services revenue and the launch of new products like the iPhone 16e and M4 MacBook Air, Apple faces challenges: a 19% year-to-date stock decline, heightened antitrust scrutiny, and intensifying competition in artificial

## Overview The **U.S. Food and Drug Administration (FDA)** is a federal agency within the Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of a wide range of products, including human and veterinary drugs, biologics, medical devices, food, cosmetics, and products that emit radiation[1][2][3]. Its mission is to advance public health by helping to speed innovations that make medical products safer, more effective, and more affordable, while providing the public with accurate, science-based information about these products[1]. ## Functions and Regulatory Scope The FDA’s regulatory authority is expansive. It oversees the approval, manufacturing, marketing, and distribution of prescription and over-the-counter drugs, vaccines, blood products, medical devices (from simple tongue depressors to complex pacemakers), dietary supplements, most foods (except some meat, poultry, and egg products regulated by the USDA), cosmetics, and tobacco products[1][2][5]. The agency also regulates electronic products that emit radiation, such as X-ray machines and microwave ovens[2][5]. Importantly, the FDA does not regulate the practice of medicine, medical services, product pricing, or health insurance reimbursement[2]. The FDA achieves its goals through a combination of **premarket reviews**, **post-market surveillance**, **facility inspections**, **enforcement actions**, and **public education**[3][4]. It maintains several adverse event reporting systems—such as MedWatch and VAERS—to monitor product safety after they reach the market[4]. The agency also plays a key role in the nation’s counterterrorism efforts by ensuring food supply security and fostering the development of medical countermeasures[1]. ## History and Key Achievements Established in 1906 with the passage of the Pure Food and Drugs Act, the FDA’s origins trace back to efforts to combat adulterated and misbranded food and drugs. Its regulatory powers expanded significantly with the