The European Chemicals Agency (ECHA) and authorities from Denmark, Germany, the Netherlands, Norway and Sweden have released a progress update on the process to restrict per- and polyfluoroalkyl substances (PFAS) in Europe. Helsinki, 20 November 2024 – The five authorities (Dossier Submitters) and ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) continue to […]

Fourth Frontier, a med-tech firm from New York and Bangalore, announced that their continuous ECG monitor, Frontier X Plus, received U.S. FDA’s 510(k) clearance. The device, worn around the chest, wirelessly relays ECG data to remote dashboards, accurately identifying cardiac rhythms such as Bradycardia, Tachycardia, Normal Sinus Rhythm, and Atrial Fibrillation. Demonstrating high signal quality

Read more at:https://health.economictimes.indiatimes.com/news/medical-devices/us-fda-approves-johnson-johnsons-device-for-heart-condition/115072267 The U.S. FDA has approved Johnson & Johnson’s Varipulse device for treating abnormal heart rhythms. Varipulse uses pulsed field ablation to create small scars inside the heart, disrupting electrical signals causing irregular heartbeats. It joins devices from Boston Scientific and Medtronic approved for atrial fibrillation, a condition characterized by an irregular heart

The Acclaim CI was granted the breakthrough device designation by the FDA in 2019. Envoy Medical received FDA approval for an investigational study of the Acclaim cochlear implant for adults with severe to profound sensorineural hearing loss. This allows them to collect initial clinical data before expanding to more patients. The Acclaim CI uses an