The nationwide study will assess the safety and efficacy of the technology that combines standard balloon dilation to open the respiratory tract with drug delivery designed to maintain symptom relief.
The AMStent System leverages a decellularized human amniotic membrane (DCAM). New pre-clinical outcomes demonstrating superior results compared to a commercially available synthetic polymer-covered stent were presented at the 2025 American Association for Bronchology and Interventional Pulmonology (AABIP) Annual Meeting.
The company initiated trials for AGENT DCB, a drug-coated coronary balloon approved for use in the U.S. and currently indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
Lab IoT adoption is growing, and recent innovations make it more promising than ever. See how IoT advances can unlock new standards of equipment uptime.
On February 15, numerous probationary staff at FDA began receiving emails notifying them they had been fired. “Unfortunately, the Agency finds that you are not fit for continued employment because your ability, knowledge and skills do not fit the Agency’s current needs, and your performance has not been adequate to justify further employment at the Agency,” said the letters.
Collaboration tackles complex challenges using data science to improve decision-making in cancer care.
To streamline processes, enhance transparency, and improve the overall efficiency of conducting clinical trials in the EU/EEA, the 3-year transition period from the CTD to the CTR requirements was established. With the end of the transition period approaching, all ongoing clinical trials that were approved under the CTD will have to be fully be transitioned to comply with the CTR. Failure to comply by 2025 will bring serious consequences.
Following a “alarming” increase in medical device submissions containing unreliable data, the FDA is reminding manufacturers and study sponsors that they are responsible for qualifying third-party test labs and closely scrutinizing all testing data.
The National Institute of Standards and Technology (NIST) has developed a system that mimics humanlike models for studying cardiovascular disease to reduce the reliance on animal testing and shorten drug development timelines.
Genomics data scientist Harsha Rajasimha, Ph.D., Founder and Executive Chairman of IndoUSrare, highlights the risks of developing AI/ML algorithms based on biased data, as well as efforts underway to improve global collaboration on the collection and sharing of health data that may help us realize the potential of AI in diagnoses and treatment of rare diseases.
