Femasys Inc. received CE mark for four women’s health products – Femaseed, Femvue, Femcerv and Femcath – after obtaining certification under the EU Medical Device Regulation. This allows the company to expand its market reach and it will now focus on delivering its innovative solutions for women’s reproductive health within the EU.
The problems with devices for low-volume conditions are well known, and regulatory agencies such as the European Union’s Medical Device Coordination Group are working to ease the regulatory hurdles for these products.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuray, Cranius, GE Healthcare, Ricoh, Stratasys, T2 Biosystems.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilemd, Alivecor, Clarius, Radical Imaging.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anumana, Digital Health Acquisition, Idoc Virtual Telehealth, Infobionic.Ai, Immunoprecise Antibodies, Metabolon, Neuroone, Nucleai, Pgxai, Proscia, VSee Lab.
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