Bioxcel Therapeutics
December 29, 2023Emerging Trends in Healthcare AI
December 30, 2023Women’s Healthcare
FDA Clearance for Scoliosis Correction System for Growing Patients, and FDA- Approved At-Home Spirometer: Aluna...
FDA - Approved At-Home Spirometer: Aluna
The FDA has granted clearance to Aluna, a portable spirometer designed to measure respiratory functions precisely and offer remote access to lung health data. Boasting hospital-level accuracy, Aluna incorporates machine-learning technology that simulates the presence of a respiratory therapist, fostering enhanced patient engagement throughout the process.
Individuals coping with chronic lung conditions, such as asthma and COPD, traditionally relied on in-person spirometry tests conducted by lung specialists. However, Aluna revolutionizes this approach by providing a convenient, at-home solution for monitoring lung health.
Similar to how individuals with diabetes employ blood glucose monitors for proactive health management, routine spirometry monitoring allows for early intervention and the optimization of treatment plans. Both patients and healthcare providers gain insights into the efficacy of current treatments, enabling timely adjustments based on a comprehensive understanding of lung health. Aluna’s mission is to modernize spirometry, expanding accessibility to a broader patient population and thereby reducing the incidence of attacks and hospitalizations.
Aluna’s mission is to modernize spirometry, making it accessible to a broader audience and minimizing the risk of attacks and hospitalizations. With FDA approval, Aluna stands as a reliable and user-friendly tool for individuals seeking an advanced, at-home solution for proactive respiratory health management.
FDA Clearance for Scoliosis Correction System for Growing Patients
The REFLECT Scoliosis Correction System developed by Globus Medical Inc. recently received FDA clearance as a non-fusion spinal device. Specifically designed to address idiopathic scoliosis, a condition with an unknown cause that commonly manifests in children and adolescents with incompletely matured bones, this innovative system offers a promising treatment avenue.
The device is utilized in orthopedic surgery and comprises bone screws, staples, a cord, and locking caps. During the procedure, staples and bone screws are strategically placed on the side of the spinal curve. The cord, connected to the bone screws through locking caps, allows surgeons to apply tension, partially straightening the curved spine. Post-surgery, the cord continues its corrective function, facilitating ongoing spinal straightening as the individual continues to grow.
Indicated for individuals whose bones are still in the growth phase, the REFLECT Scoliosis Correction System is recommended for those requiring surgical intervention to achieve and maintain correction for progressive idiopathic scoliosis. This becomes particularly crucial when using traditional braces has proven ineffective in correcting spinal curvature. By preventing the progression of spinal curves and offering an alternative to spinal fusion—the current standard-of-care treatment—the REFLECT system stands at the forefront of scoliosis management. Its FDA clearance underscores its safety and effectiveness, providing both patients and healthcare professionals with a cutting-edge solution for addressing this challenging condition.
