Medical Device Regulatory | SCIENCE ARENA

Medical Device Regulatory | SCIENCE ARENA

5/14/2025, 6:50:46 PM

US FDA Data 2012 Onwards-

Medical Device Regulatory | SCIENCE ARENA

5/17/2025, 1:58:45 AM

*FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease* The U.S. Food and Drug Administration today cleared for marketing the first in vitro diagnostic device that tests blood to aid in diagnosing Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio measures two proteins, pTau217 and β-amyloid 1-42, found in human plasma, a component of blood, and calculates the numerical ratio of the levels of the two proteins. This ratio is correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan. Similar FDA-authorized/cleared tests, one from the same company as this new test, are used with cerebrospinal fluid (CSF) samples, which are collected through an invasive lumbar puncture, also called a spinal tap. This new Lumipulse test only requires a simple blood draw, making it less invasive and much easier for patients to access. During review of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the FDA evaluated data from a multi-center clinical study of 499 individual plasma samples from adults who were cognitively impaired. The samples were tested by the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio and compared with amyloid PET scan or CSF test results. In this clinical study, 91.7% of individuals with Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio positive results had the presence of amyloid plaques by PET scan or CSF test result, and 97.3 % of individuals with negative results had a negative amyloid PET scan or CSF test result. Less than 20% of the 499 patients tested received an indeterminate Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio result. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The risks associated with the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio are mainly the possibility of false positive and false negative test results.

Medical Device Regulatory | SCIENCE ARENA

5/14/2025, 7:02:08 PM

*US FDA Recall data 2012 Onwards till date* - a Detailed Analysis is Ongoing to strengthen the Quality and applicable standard requirements. Soon Will be Published by Regulators and other statuary bodies. * So Far Medical Device Sector faced Lot of Quality Issues due to clarity and negligence. Since these data are managed by Only US, so Other Regulators are being intersted in evaluation to trace in thier jurisdiction. * Since India does not have trace mechanism for such data and issues so any quantiative analysis is not available till date.

Medical Device Regulatory | SCIENCE ARENA

5/16/2025, 10:23:28 AM

First Session by EPCMD with CDSCO for guidance on Medical and IVD devices

Medical Device Regulatory | SCIENCE ARENA

5/20/2025, 5:57:15 PM

https://www.regulatorymedicaldevice.com/2024/10/biological-risk-assessment-and-report.html

Medical Device Regulatory | SCIENCE ARENA

5/18/2025, 3:35:10 AM

🔍 *Verify Before You Submit!* ✅ As part of the *global harmonisation of medical device regulations* , many regulatory authorities are working closely with third-party service providers to streamline device approvals and market placement. 🌍 These collaborative systems aim to simplify international compliance—but many of these frameworks are still in development. Meanwhile, alternative platforms or services claiming full compliance are already operating, yet they are not officially licensed nor do they share their compliance status with national regulators. 🚨 Before you submit any regulatory documentation, always verify the licensing and authorization status of the service provider with your national regulatory authority. This step is critical to: * Avoid non-compliant submissions ❌ * Prevent costly delays 🕒 * Ensure successful market access for your device ✅ 👉 Stay informed. Stay compliant. Always verify. https://www.regulatorymedicaldevice.com/