A research team from the National University Health System (NUHS) was awarded a translational grant of S$4.9 million (US$3.6 million) from the National Research Foundation Singapore Central Gap Fund to further develop its personalized mitral valve bioprosthesis. Currently, around 500 patients in Singapore and more than 1 million around the world require mitral valve surgery annually.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endologix, Nevro.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aquarius Surgical Technologies, Bioivt, BIRD Foundation, Carmat, Flywheel, Rochal Industries, Sanara Medtech, Siemens Healthineers, Tissue Solutions.
Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.
SD Biosensor Inc. made a splash in its KOSPI board debut on July 16, raising a total ₩776.4 billion (US$679.26 million). The company will now use the funds to mass-produce and promote the company’s diagnostic machines for various indications, including COVID-19.
The COVID-19 pandemic brought in-person inspections of device manufacturing sites to a near halt, but that has left the agency with a significant backlog in these inspections. The FDA’s Associate Commissioner for Regulatory Affairs Judith McMeekin said recently that the FDA is intent on prodding Congress to provide the Office of Regulatory Affairs (ORA) with more monies, particularly given the meager increases in funding for oversight of the med-tech industry in the past few years.
The U.S. Patent and Trademark Office (PTO) has responded to the Supreme Court ruling in the so-called Arthrex case, which affects how the agency will handle inter partes reviews (IPR) decided by administrative patent judges (APJs). PTO said litigants to IPRs can request a review by the director of the agency only in limited circumstances, however, potentially limiting litigants to one administrative path following an unfavorable IPR outcome.
PARIS – Aleva Neurotherapeutics SA reported the first successful implantation of its Directstim directional deep brain stimulation (DBS) system into a patient suffering from Parkinson’s disease. The procedure involving this new generation of active brain device was performed by neurosurgeon Stephan Sobottka, from the Clinic for Neurosurgery at the University Hospital Carl Gustav Carus in Dresden, Germany.
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