Although U.S. President Joe Biden has yet to nominate his choice to lead the FDA, his nomination of Xavier Becerra as the next Health and Human Services (HHS) secretary – and Becerra’s Senate confirmation March 18 – could signal a shift to a more conservative approach at the FDA when it comes to approving new drugs and devices. Read More
A U.S. Senate committee met March 18 to review the federal government’s response to the COVID-19 pandemic, during which former FDA commissioner David Kessler said the Trump administration’s vaccine contracts were expensive, but effective in ensuring a robust supply. Nonetheless, Sen. Chris Murphy (D-Conn.) said one vaccine manufacturer had recently voiced an interest in charging more on a per-dose basis for its vaccine, and suggested that the cost of booster shots should perhaps be examined anew by the Biden administration. Read More
COVID-19 continues to dramatically reconfigure medicine as an ever-broadening array of digital therapies rolls out and telemedicine tackles increasingly complex applications. Abbott Laboratories’ newly launched Neurosphere Virtual Clinic exploits both trends to make management of chronic pain and movement disorders easier for patients. Read More
HONG KONG – SK Bioscience Ltd.’s shares soared as much as 30% in their KOSPI board debut on Thursday. The 22.95 million shares on offer opened at ₩130,000 (US$115.08) and were trading at ₩169,000 by the close of the trading day, raising ₩1.5 trillion, or $1.33 billion. SK Bioscience had priced the shares at the top of the ₩49,000 to ₩65,000 range. Read More
TORONTO – The University of Toronto (U of T) is collaborating with Kawasaki, Japan’s Fujitsu Laboratories Ltd. to dramatically streamline radiation treatment plans for Gamma Knife brain tumor radiosurgery. Together, they are leveraging Fujitsu's Digital Annealer described as quantum-inspired computing technology to create treatment plans for complex surgical procedures in minutes, while maintaining accuracy and minimizing dosage to surrounding healthy tissue. Read More
Combining research on emerging technologies with an accelerator program and a dedicated equity fund, the European Commission (EC) launched the European Innovation Council March 18 to invest in promising research and to scale up innovative startups and small- and medium-size businesses. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Geneseeq Technology, Illumina, Penumbra. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Boston Scientific, Braintale, Catalyst, Life Spine, Stimdia. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House. Read More
Keeping you up to date on recent developments in diagnostics, including: Data flaws sink current AI models for COVID-19 diagnosis; Smartphone-based gaze may provide a scalable, digital biomarker of mental fatigue; AI developed to predict disease based on genetic mutations; High blood fats, sugars alter antigen processing. Read More
