Surgibox Inc. won a CE mark for two components of its Surgifield system, an ultraportable sterile system that enables safe surgery any place, any time. The five-year-old startup also landed a humanitarian use exemption for use of the system in war-torn Ukraine. Read More
Results from the largest trial yet in transcatheter valve replacement continues to demonstrate strong results for Edwards Lifesciences Corp.’s Evoque system. A late-breaking presentation at the PCR London Valves 2022 meeting provided one-year follow-up results from the Triscend study showing better than 90% survival and 99% freedom from heart failure hospitalization. Further, 97.6% of patients maintained mild or trace tricuspid regurgitation. Read More
A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands. Read More
Both the Hong Kong Stock Market and the Shanghai STAR Market have seen med-tech companies, namely Orbusneich Medical Group Holdings Ltd. and Shanghai Genext Medical Technology Co. Ltd., making a rush to be listed by the end of 2022. Read More
A team from the University of Geneva (UNIGE) in Switzerland and the Ludwig Maximilian University of Munich in Germany has succeeded in developing a fully biodegradable nanoparticle able to deliver a new anti-inflammatory drug directly into macrophages where an uncontrolled inflammatory response has been triggered. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Candesant Biomedical, Centinel Spine, Masimo, MTF Biologics, Renalytix. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Centaur Labs, Deepc, Caire, GEPA, Immunovia, Magcorp, MGC Diagnostics, Nanomix, Neovasc, Royal Philips, Segmed, Uromems. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Egg Medical, Electromed, Pulmonx, Surgibox, Treace Medical Concepts. Read More