Vivasure Medical Ltd. has designed a sutureless and absorbable venous vessel closure for use following percutaneous cardiovascular procedures, such as transcatheter mitral valve or tricuspid valve repair or replacement. The Perqseal Blue technology builds on the Galway, Ireland-based company’s Perqseal, which received the CE mark for vascular closure of femoral arteries in 2016.
The FDA granted breakthrough device designation to Royal Philips NV for its laser-assisted inferior vena cava (IVC) filter removal device. The Amsterdam-based company designed the device to ablate tissue for removing an IVC filter when previous methods of removal have already failed.
The medical device development tool (MDDT) may come across as so much regulatory esoterica of little utility to most device makers, but that perspective might be unduly pessimistic. The FDA’s Edward Margerrison, director of the Office of Science and Engineering Laboratories, said the agency is intent on making MDDTs as ordinary as possible to allow device makers to do what they do best, which is to focus on making the best device they can.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has embarked on wide-ranging reforms that are designed to make the most of post-Brexit regulatory flexibility while capitalizing on the ‘spirit of the pandemic,’ which has seen it rise to the occasion in supporting rapid set up of large-scale randomized clinical trials and approvals of COVID-19 vaccines.
The Hong Kong Polytechnic University (PolyU) has developed new side-hole polymer optical fiber sensors, which can be used in multiple medical treatments without the drawbacks of other optical fibers used in the past. The biocompatible plastic sensors are humidity insensitive, supple and shatter-resistant. This means they can be used in various medical settings, ranging from surgical instrumentation, diagnostics to imaging equipment and sensor-based medical devices.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alayacare, Align Technology, B-Secur, Biocept, Biostrap, Blackrock Neurotech, C2i Genomics, Canon Medical Systems, Céleri Health, Ciba Health, Clearpoint Neuro, Codex DNA, Full Body Insight, GE Healthcare, Honeywell, Hydrix, Ibex Medical Analytics, Imeka, Inmune Bio, Interaxon, Joimax, Maravai Lifesciences, Microsoft, New Harmony, North American Science Associates, Oncovision, Option Care Health, Premier, Quibim, Raisonance, Safeguard Medical, Terasaki Institute for Biomedical Innovation, Tetratherix, Trilink Biotechnologies, Unilabs, Vetrun, Vital Images.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Boston Scientific, Kurin, Lumithera, Smith+Nephew.
While regulators and policymakers across the world are stressing the need for equitable access to COVID-19 vaccines, therapies and devices, their own policies and regulations may be getting in the way of that goal. The World Trade Organization (WTO) released a list of trade-related bottlenecks July 20 that are hindering access to pandemic-related medical products.
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