Neo Medical SA received certification under the EU Medical Device Regulation for its entire portfolio of spine surgical technologies. The approval means that the company can continue selling its products, which helps with the surgical treatment of back pain, across markets in Europe as they are in compliance with the high-quality control standards required for medical devices. Read More
In breaking news, Wave Neuroscience LLC received breakthrough device designation from the U.S. FDA for its magnetic electroencephalogram resonance therapy for adjunctive treatment of post-traumatic stress disorder (PTSD), making its technology the first medical device approved to treat the debilitating condition, the company said. Read More
Mica AI Medical Ltd. is looking to transform the early diagnosis of breast cancer with its software which helps radiologists analyze mammograms more effectively. The company recently signed a collaboration and licensing agreement with Baptist Health South Florida in a bid to bring its technology to the U.S. market. Read More
A U.K. study has uncovered distinctive genetic drivers of type 2 diabetes in South Asians that lead to faster development of complications, the need for earlier insulin replacement therapy and a weaker response to some widely prescribed drugs. That points to the need to refine care pathways. But in addition, the research provides a potent illustration of how the under-representation in genomics databases of people who are not of white European origin can skew results and be a source of discrimination. Read More
New hires and promotions in the med-tech industry, including: Adapthealth, Delfi Diagnostics, Hyperfine, Second Heart Assist, Transmedics Group, Vitrolife. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Charité-University Hospital, Immunexpress, Lunit, Medtronic. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Avails, Distalmotion, Femasys, Glucotrack, GVS, Haemonetics, Inari Medical, Macnica, Reveal Genomics, Seno Medical, Sony Group, Vizient. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beacon Biosignals, GE Healthcare, Matortho, Nonin Medical, Screenpoint Medical, Wave Neuroscience. Read More
