When Wellness Runs Ahead of Science, Pg13

Key Highlights:

• Entrepreneur Deepinder Goyal launched "Temple," a wearable device priced at ₹85,000, claiming to track brain blood flow patterns and function.
• Public health expert Dr. Cyriac Abby Philips, "The Liver Doc," and other medical professionals have questioned Temple's scientific claims due to a lack of peer-reviewed studies.
• Goyal maintains that Temple is a fitness and Artificial Intelligence (AI) product, not a medical device, and therefore does not require medical validation.
• The controversy highlights concerns about India's booming wellness economy, which largely operates outside the purview of regulated medical markets.
• The device uses photoplethysmography (PPG) technology, similar to smartwatches, to measure blood flow, but its ability to accurately measure cerebral blood flow is debated.

Detailed Insights:

• Temple is designed to stick to the forehead and track metrics like "BrainFlow" and "Entropy," which are claimed to indicate cerebral circulation and the body's effort to sustain itself.
• Critics argue that the device likely measures blood flow in the superficial temporal artery (supplying the scalp and face) rather than the internal carotid or vertebral arteries that supply the brain.
• Existing studies cited by Temple are primarily company-funded, involve small sample sizes, and have not undergone independent peer review, raising questions about their scientific rigor.
• India's Medical Device Rules, 2017, regulate medical devices based on risk classification (Class A to D) under the Central Drugs Standard Control Organisation (CDSCO).
• Products not classified as medical devices, such as general wellness or fitness trackers, often face less stringent regulatory oversight regarding scientific claims.
• The debate underscores the need for clear regulatory boundaries and scientific accountability for products making health-related claims, especially in the rapidly growing wellness sector.

Key Concepts Involved:

• Wellness Economy: An industry sector focused on products and services promoting health and well-being, often distinct from traditional medical care.
• Peer-reviewed studies: Research evaluated by independent experts in the same field to ensure quality, validity, and originality before publication.
• Medical Device Rules, 2017: Indian regulations governing the manufacture, import, sale, and distribution of medical devices, classifying them by risk.