Abbott Laboratories saw improvement with its medical devices and diagnostics in the third quarter, which featured wins in the areas of COVID-19, diabetes, and structural heart. The company revealed its quarterly results on a Oct. 21 call, during which management said it was increasing its guidance for full-year adjusted earnings per share (EPS) to at least $3.55. Read More
Digital medicine startup Appliedvr Inc. has gained breakthrough device designation status from the U.S. FDA for its virtual reality (VR) platform for treating treatment-resistant fibromyalgia and chronic intractable lower back pain. The designation follows the completion of a clinical trial assessing VR-based therapy for self-management of chronic pain at home. Read More
Bluestar Genomics Inc. identified DNA-based epigenomic changes that could be used as new biomarkers that can detect pancreatic cancer before the malignancy, one of the deadliest of all cancers, becomes untreatable. The study was published in Nature Communications. Read More
The U.S. FDA’s recent decision to pass on any emergency use authorization (EUA) filings for tests for the COVID-19 pandemic is well known, but the agency had a chance to lend some additional information on that question in the Oct. 21 town hall. Despite the opportunity to clarify some of the underlying questions, Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said little more than that the change was made “largely because the FDA cannot require an EUA, according to the HHS statement.” Read More
While the FDA’s approach to evaluating safety and efficacy in the development and review of COVID-19 vaccines for the U.S. market will be at the center of its Oct. 22 advisory committee meeting, the panel also will be asked to discuss the practicalities, and ethics, of continuing to conduct trials once a candidate has been granted an emergency use authorization. Read More
A multi-institutional team of researchers has implicated lipid droplets, which are key energy storage units of individual cells, in innate immune defense. "Until now it was thought that [lipid droplets] were at the service of viruses or bacteria during infection," Albert Pol told BioWorld. The new study, which was published in the Oct. 16, 2020, issue of Science, demonstrated that cells also use the droplets to coordinate their defense. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advamed says shipped tests reach 200M mark; Brazil, U.S. expand on 2011 trade handshake; Federal Circuit reaches split decision in review of IPR. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akili, Apyx Medical, Day Zero Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acuitive, Appliedvr, Certest, Tyber, Venturemed. Read More
Keeping you up to date on recent developments in orthopedics, including: Magnetic field and hydrogels could be used to grow new cartilage; COVID-19 pandemic has dramatic impact on osteoporosis management, finds new global study; Casting call: Why immobilizing helps in healing; Osteoarthritis biomarker could help 300 million people worldwide. Read More
