Abbott Laboratories has seen the launch of the IonicRF Generator, which delivers a nonsurgical, minimally invasive treatment for the management of pain in the nervous system. The generator is a radiofrequency (RF) ablation device that uses heat to target specific nerves and block pain signals from reaching the brain. The launch of Abbott's IonicRF Generator looks to help the estimated 50 million people in the U.S. currently living with chronic pain. Read More
Varian Medical Systems Inc. has invested $10 million in and inked a collaboration agreement with Cota Inc., a Boston-based curator of oncology clinical data. The radiation oncology company will now offer its customers access to Cota’s oncology real-world analytics and data curation services, which aggregate electronic health record (EHR) data to yield meaningful insights. Read More
As cases skyrocket and more questions arise about the high rate of false negatives returned by rapid testing in COVID-19 cases, a simple, new diagnostic test offers far greater accuracy. Researchers around the globe have found that artificial intelligence can detect coronavirus infections in recorded forced coughs, with nearly 100% accuracy in asymptomatic or presymptomatic cases, making it an ideal quick screening test. Forced cough or voice analysis shows strong results in other conditions, too, including pulmonary hypertension and, surprisingly, Alzheimer's disease. Read More
The U.S. FDA final guidance for microneedling devices is a product-specific guidance, but it raises questions about the agency’s perspective on how a manufacturer’s intended use is inferred. Despite concerns voiced by industry, the microneedling devices final guidance retains a feature of the draft that allows the agency to infer intended use from the manufacturer’s “expressions,” a provision that raises yet again the long-standing commercial speech problem. Read More
HONG KONG – Los Angeles-based medical device accelerator Medtech Innovator and Asia Pacific Medical Technology Association (APACMed) have picked five finalists to compete for the title of the 2020 Asia Pacific Grand Prize winner, out of more than 170 applicants. Cartosense, Healthy Networks, Remidio, Sporogenics, and X-Zell were selected for the Medtech Innovator Asia Pacific competition, now in its second year. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDC updates vaccine guidance; Russia launches doctor-driven shortage reporting service. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allurion Technologies, Axonics, Surmodics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocartis, Icotec, Materialise, Medcad. Read More
Keeping you up to date on recent developments in oncology, including: Blood test does well in distinguishing between malignant, benign growths; PARP inhibition can assist tumor cells; CDK 4/6 inhibitors affect transcriptional landscape. Read More
