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FDA Approves First OTC Glucose Monitor, Dexcom’s Stelo System – and it can Pair with your Smartphone

Anubhav — Wed, 06 Mar 2024 16:14:22 +0000

A breakthrough for diabetes management arrived on March 6th with the FDA‘s approval of Dexcom’s Stelo glucose biosensor system. This revolutionary device, the first of its kind, allows for over-the-counter, prescription-free blood sugar monitoring for individuals with non-insulin-dependent diabetes or those at risk of developing the condition.

The glucose monitor displays readings every 15 minutes

Unlike traditional methods, Stelo utilizes a wearable sensor and smartphone app to continuously monitor glucose levels, displaying readings every 15 minutes. Each sensor lasts up to 15 days before needing replacement, offering a convenient and long-lasting solution.

The FDA highlighted the significance of this approval, emphasizing its potential to increase accessibility to blood sugar monitoring and empower individuals to manage their health from the comfort of their homes.

While Stelo represents a major step forward, the ultimate goal in diabetes management remains non-invasive blood glucose monitoring. This technology, though initially planned for the Apple Watch, has yet to be realized due to current limitations. The FDA also cautions against unapproved non-invasive alternatives, stressing their unreliability.

Despite the current absence of non-invasive options, Dexcom’s Stelo marks a significant advancement in diabetes management, offering a convenient and accessible solution for many people. The future of blood sugar monitoring, however, holds the promise of even more innovative and non-invasive approaches.

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Neuralink Receives Approval from FDA for Human Testing

Anubhav — Fri, 26 May 2023 06:37:22 +0000

Neuralink, the brain-chip firm founded by Elon Musk, has just received approval from the US Food and Drugs Administration (FDA) to conduct its first tests on humans. This groundbreaking development brings Musk’s vision of connecting brains with computers one step closer to reality.

The Neuralink Chips have undergone successful testing in Monkeys

Neuralink aims to leverage microchips to restore vision and mobility in people, while also assisting individuals with disabilities in using computers and mobile technology. The chips, which have undergone successful testing in monkeys, have the capability to interpret brain signals and transmit information to devices via Bluetooth.

Previously, Neuralink’s bid for FDA approval was rejected due to safety concerns. However, the company has made significant progress since then, and the recent approval is a testament to the hard work and collaboration between Neuralink and the FDA.

While Neuralink has not yet announced plans to recruit participants for the trials, the company is eager to make its technology accessible to a wide range of individuals in the future. The focus on safety, accessibility, and reliability is a top priority during the engineering process.

However, experts have warned that extensive testing is necessary to address both technical and ethical challenges before Neuralink’s brain implants can be widely available. These tests will ensure the reliability and efficacy of the technology while addressing any potential concerns.

Neuralink’s announcement comes in the wake of an exciting breakthrough by Swiss researchers who developed a system of brain implants enabling a paralyzed man to walk simply by thinking about it. This achievement demonstrates the incredible potential of brain-computer interfaces in transforming the lives of individuals with disabilities.

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Neuralink Human Trials Request for Brain Implant Denied by FDA: Report

Sean — Fri, 03 Mar 2023 10:49:54 +0000

Elon Musk‘s Neuralink has apparently been denied human trials for its brain implants by the FDA. The company has been working in the field of brain computer interface but was denied the trials back in 2022. So here are all the details.

According to a new report, former and current employees of the startup have revealed that “The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue.” The FDA has expressed concerns regarding the battery system and its novel transdermal charging capabilities.

The issue is related to the device’s chance of failing after being implanted. The new report added that the agency is looking for reassurances that the battery is “very unlikely to fail”. In other words, the FDA would only approve of the trials once Neuralink proves safety of the implant since the discharge of electrical current or heat energy from a ruptured pack can possibly lead to burning of the surrounding tissue.

The FDA also stated that there were potential risks if the device would be needed to be removed for upgrades or replacements since the small size of the electrical leads that extend into the patient’s brain. One Starlink employee stated that “He can’t appreciate that this is not a car. This is a person’s brain. This is not a toy.”

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