…the programmed death ligand-1 (PD-L1) protein in formalin- fixed, paraffin -embedded tissue sections. Add to the identification of patients treated with TECENTRIQ® (atentilizumab) for non -small cell lung cancer (NSCLC)…
…the programmed death ligand-1 (PD-L1) protein in formalin- fixed, paraffin -embedded tissue sections. Add to the identification of patients treated with TECENTRIQ® (atentilizumab) for non -small cell lung cancer (NSCLC)…
…How much time do companies have left to recertify their devices? Badwal: Companies that already have an MDD certification, as long as they launch an application with the notified body…
…How much time do companies have left to recertify their devices? Badwal: Companies that already have an MDD certification, as long as they launch an application with the notified body…
…Medcrypt noted new regulatory actions including FDA’s announcement that is refusing to accept any medical devices that fail to comply with its mandatory pre- and post-market guidelines. “The urgency for…
…Medcrypt noted new regulatory actions including FDA’s announcement that is refusing to accept any medical devices that fail to comply with its mandatory pre- and post-market guidelines. “The urgency for…
…researchers should implement strategies such as compliance monitoring and robust data analysis. Continuous or real-time data monitoring is more commonly used in a healthcare setting, especially in acute situations that…
…researchers should implement strategies such as compliance monitoring and robust data analysis. Continuous or real-time data monitoring is more commonly used in a healthcare setting, especially in acute situations that…
With a growing focus on climate commitment, MedTech companies are examining how their products are repaired, refurbished and recycled. The Health Solutions team at Flex is partnering with them on…
With a growing focus on climate commitment, MedTech companies are examining how their products are repaired, refurbished and recycled. The Health Solutions team at Flex is partnering with them on…
…on the management committee. Development of documents is driven by regulators. There is a clear and consistent public consultation process to allow for stakeholder engagement. On September 18, 2023, the…
…on the management committee. Development of documents is driven by regulators. There is a clear and consistent public consultation process to allow for stakeholder engagement. On September 18, 2023, the…
The FDA has granted NeuroAccess from Cordance Medical, a medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, Breakthrough Device Designation. The NeuroAccess device is…
The FDA has granted NeuroAccess from Cordance Medical, a medical device company focused on opening the Blood-Brain Barrier (BBB) to facilitate liquid biopsy, Breakthrough Device Designation. The NeuroAccess device is…
The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to…
The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to…
…usher in a new paradigm of empowerment and compassion in mental healthcare. References: [1] https://www.forbes.com/sites/otsuka/2023/06/26/prescription-digital-therapeutics-are-expanding-what-it-means-to-treat-mental-health/?sh=6372cffd4bcf&gclid=Cj0KCQjwy4KqBhD0ARIsAEbCt6igw5Yxv94PQCfr9OfLSqYBQL_TvrFqsRe_Ci4UxkmKLzJaXxRMs2IaAkztEALw_wcB [2] “‘Why AI-Powered Mental Health Solutions Are Vital.”, Intelliverse.ai, September 28, 2023, https://www.linkedin.com/pulse/why-ai-powered-mental-health-solutions-vital-intelliverse-ai-lab/ …
…usher in a new paradigm of empowerment and compassion in mental healthcare. References: [1] https://www.forbes.com/sites/otsuka/2023/06/26/prescription-digital-therapeutics-are-expanding-what-it-means-to-treat-mental-health/?sh=6372cffd4bcf&gclid=Cj0KCQjwy4KqBhD0ARIsAEbCt6igw5Yxv94PQCfr9OfLSqYBQL_TvrFqsRe_Ci4UxkmKLzJaXxRMs2IaAkztEALw_wcB [2] “‘Why AI-Powered Mental Health Solutions Are Vital.”, Intelliverse.ai, September 28, 2023, https://www.linkedin.com/pulse/why-ai-powered-mental-health-solutions-vital-intelliverse-ai-lab/ …
