Keeping you up to date on recent developments in cardiology, including: TAVR patients at low surgical risk still ahead vs. SAVR, but thrombosis a concern; Heart failure numbers nearly doubled between 1990 and 2017; COVID exerting large effect on heart health.
The FDA issued an advisory about the use of thermal imaging systems as screening instruments for the COVID-19 pandemic landing the same day as a warning letter to Certify Global Inc. The agency’s concern is that these systems are being used without consideration for the limitations, including that they are not appropriate for mass screenings due to inaccurate findings that could elevate the risk of spread of the SARS-CoV-2 virus.
PARIS – Median Technologies SA has unveiled a new clinical development plan for its Ibiopsy platform to provide early diagnosis of lung cancer in at-risk populations using low dose CT scans. Median executives said they hope to demonstrate the potential of deep learning in identifying lung lesions and characterizing them as malignant or benign.
PERTH, Australia – Genetic Technologies Ltd. signed a co-exclusive licensing deal with U.S.-based central lab Infinity Biologix LLC (IBX) for the production, sale and distribution of Genetic Technology’s COVID-19 serious disease risk test in the U.S. Branded as Genetype, the genotyping test combines a patient’s clinical profile with their genetic information to compute a patient’s risk of developing severe disease from COVID-19.
HONG KONG – Rokit Healthcare Inc. is working toward its goal of listing on the Korean stock exchange by July or August 2021. The Seoul, South Korea-based company will issue 12 million shares and targets setting the price range as early as July 2021. KB Securities Co. Ltd. and Mirae Asset will serve as organizers for the IPO.
More than doubling the amount raised by this point last month, med-tech financings are coming out strong in 2021, beating by 67% the early months of last year. The full year of 2020 broke med-tech financings records, reaching $59.7 billion. With $10.63 billion already raised this year, 2021 is well on its way to at least match last year’s amount.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CDSCO eyes recognition of ASTM standards; Device makers, docs blast radiation oncology payment model.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Illumina, Second Sight.