The U.S. FDA drafted a guidance for clinical trials for evaluation of optical imaging (OI) agents. The policy may allow clinical studies to evaluate an OI agent by means of an intrasubject study design, which would save time and money for the sponsor.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aiforia, Atomic Alchemy, Hip Innovation, Oklo, Orion, Sanuwave.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Spark Biomedical.
The executive orders (EOs) pouring out of the Trump White House, and the resulting court challenges, continue to pile up, deepening the uncertainty hanging over the life sciences sector and the U.S. economy in general.
Sofinnova Partners raised a whopping €1.2 billion (US$1.26 billion) over the past year to invest in life sciences companies ranging from incubation to later-stage growth, and spanning biotech, med tech, industrial biotech and digital medicine.
In an advance that could significantly lighten the load for caretakers in the “sandwich generation” and reduce loneliness in elderly patients, Aspargo Labs Inc. developed a metered delivery device that optimizes absorption of pharmaceuticals and reminds users to take their medications.
The world of machine learning-enabled medical technology is advancing rapidly, and regulators are struggling to keep up, and Health Canada has joined the ranks of regulators who are tackling these technologies.
Royal Phillips NV opted to withdraw the Tack endovascular repair device only six years after the U.S. FDA’s approved it. Tack is designed to repair vascular dissection caused by angioplasty. The associated recall lists 20 injuries and no fatalities, but the device design might be a culprit in forcing the withdrawal of the Tack.
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