Swift Biosciences Inc. released an S gene panel for SARS-CoV-2 that covers 100% of the gene even with minimal viral titers. The S gene controls the spike protein, which enables the virus to bind to cells and affects transmissibility, and has accumulated multiple mutations in the concerning variants recently discovered in the U.K., South Africa, Brazil, Denmark and the U.S. The panel is expected to enable rapid scaling of surveillance efforts of the new strains and can be run by any lab using the Illumina system. Read More
Hologic Inc. kicked off its fiscal year 2021 with gusto, reporting revenue of $1.61 billion – up 89.3% year over year, or 86.5% on a constant currency basis. Worldwide sales of molecular diagnostics exceeded expectations, jumping 457.6% to $995.3 million as the company ramped up production to meet growing demand for its two SARS-CoV-2 assays that run on the fully automated Panther and Panther Fusion systems. Read More
Stryker Corp. reported Jan. 27 that per-share earnings for the fourth quarter of 2020 reached $2.81, but organic sales fell roughly 1%, largely an artifact of the COVID-19 pandemic. The company’s acquisition of Wright Medical Group NV, of Amsterdam, is part of a source of optimism for the company, however, as is the fact that the company’s sales in emerging markets continue to buoy Stryker’s outlook for 2021. Read More
PARIS – Neos Surgery SL has been awarded funding under the leading European program for innovative SMEs, the EIC accelerator. (previously known as SME Instrument). This Spanish med-tech company was one of just 38 projects selected from among 4,200 applicants from 18 countries across Europe. Neos has been awarded a non-repayable grant of $2.3 million towards developing its groundbreaking Disc Care device, used in the treatment of herniated disc. Read More
For at least the past decade – under both the Obama and Trump administrations, and perhaps even in previous administrations – the U.S. Department of Health and Human Services has been using the “Bank of BARDA” to routinely cover millions of dollars of unrelated spending at the Office of Assistant Secretary for Preparedness and Response, the U.S. Office of Special Counsel said in letters yesterday to President Joe Biden and Congress. Read More
New hires and promotions in the med-tech industry, including: Abcam, Biofidelity, Cardiovascular Systems, Exactech, Guerbet, HD Medical, Novo Integrated Sciences, Worldwide Clinical Trials. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Genocea, Medalliance, Orthofix, Universal Diagnostics. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Medtech, DNA Genotekm, Global Instrumentation, Perspectum. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Krishnamoorthi eyes ventilator contract; TGA fines company for failure to provide masks; U.S. PPE hoarder indicted; CAP supports Defense Production Act; South African variant in U.S.; GAO: More needs to be done to respond to COVID-19; Biden orders review of scientific-integrity policies. Read More
Keeping you up to date on recent developments in diagnostics, including: Diagnosing myotonia; Lumbar spine MRI interpretation; Gray matter damage in MS starts at synapses. Read More
