A Regulatory Affairs Specialist has pleaded guilty to forging FDA documents and leading his bosses to believe they had a green light to put their medical devices on the market
Wearable ultrasound can detect tumors, cysts in breasts: A wearable ultrasound patch that can conform to the breast has been developed by researchers to detect abnormalities, such as tumors and cysts. The patch was able to scan for cysts as small as three millimeters during a study
FDA issues warning on unauthorized ultrasound devices: The FDA has warned consumers not to buy or use unauthorized ultrasound medical devices manufactured and sold by Well-Being Reality, CellQuicken, and RoyalVibe Health as these devices have not been reviewed, cleared, or approved by the FDA. People who use the ultrasound devices may experience adverse events such as muscle weakness, nerve damage, pain, scarring, burns and bruising, the Agency said.
Artificial Intelligence (AI) may predict if new drugs can cause birth defects: Artificial intelligence identified approved drugs most likely to cause birth defects and might be able to predict teratogenicity of preclinical compounds, researchers reported in the journal Communications Medicine. The model uses semi-supervised learning to integrate data on drugs, genes and birth defects, creating “knowledge graphs” that could help predict the likelihood that certain genes, drugs or molecules would cause birth defects.
Wearable monitors lactate for muscle fatigue prediction: A wearable sweat sensor that has a bigger sweat reservoir and continuously monitors lactate to help predict muscle fatigue has been designed by Tokyo University of Science researchers. A study found the wearable sustained a stable response for two hours, and sweat flow rate did not impact its measurement of lactate.
Lower dementia risk seen with hearing-aid use in high-risk individuals: A study found that the use of hearing aids among older adults at higher risk of developing dementia was associated with 48% less cognitive change over three years.
Deep learning may guide Crohn’s Disease (CD) treatment: A deep learning model that analyzes capsule endoscopy videos identified patients newly diagnosed with Crohn’s disease who might benefit from biologic therapy, according to a study published in Therapeutic Advances in Gastroenterology. The model detected and accurately graded inflammation indicators in CE images and outperformed a standard scoring system when predicting the need for biologic therapy.
Implantable heart valve grows with a child thanks to new manufacturing method: A research team at the Wyss Institute and Harvard’s John A. Paulson School of Engineering and Applied Sciences has developed a nanofiber fabrication technique to rapidly manufacture heart valves with regenerative and growth potential. This new manufacturing method will likely be useful for other medical devices, they said.
Test could diagnose cancer in patients with non-specific symptoms: A study in the journal The Lancet Oncology found that a methylation-based multicancer early detection test demonstrated a 98.4% specificity and 66.3% sensitivity, with its sensitivity increasing with the increase of cancer stage and age. “MCED test results can help assess the risk that a symptom is due to cancer, providing a means for primary care physicians to decide whom to urgently investigate,” researchers wrote.
FDA released draft guidance will also focus on digital health technologies