Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels. Read More
The Office of the National Coordinator (ONC) and CMS both posted their final rules for electronic health records (EHRs), and analysts with Cowen Washington Research Group said both rules essentially replicate the draft versions. The provisions dealing with data blocking and interoperability are expected to benefit developers of HER systems in the near term, and telehealth should also benefit, albeit over a longer scale of time. Read More
Swiss researchers set out to identify and analyze vital sign data that could offer a window into predicting circulatory failure, which could enable more effective prevention of catastrophic events in the ICU. Read More
Avellino Lab USA Inc. has developed a diagnostic test for the novel coronavirus SARS-CoV-2, which has been validated in keeping with the U.S. Food and Drug Administration (FDA)'s Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. Physicians can order the assay now, while the company continues testing. Read More
Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Delphinus, Nuvasive, Sight Sciences, Sinusonic. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Assure Holdings, BD, Certest Biotec, Change Healthcare, Clearwave, Curetis, Imprivata, Masimo, Mckesson, Microsoft, National Comprehensive Cancer Network, Nemaura Medical, Opgen, Prevencio, Unlimited Systems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dianosic, Keystone Heart. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Applied Biosystems, Cardinal Health, Qiagen, Roche. Read More
Keeping you up to date on recent developments in oncology, including: Cost effectiveness of biomarker testing for lung cancer screening eligibility still iffy; Unexpected mechanism, combination possibilities for CDK 4/6 inhibitors; Protons pushing into Peoria; BWXT on the move in Tc-99 production. Read More
