Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Carlsmed, Rhein Laser, Zimmer Biomet.
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.
New hires and promotions in the med-tech industry, including: Adapthealth, Delfi Diagnostics, Hyperfine, Second Heart Assist, Transmedics Group, Vitrolife.
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.
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.
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.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Charité-University Hospital, Immunexpress, Lunit, Medtronic.
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