Japan approves IMCIVREE for acquired hypothalamic obesity, expanding Rhythm Pharmaceuticals’ global franchise. See what the approval means for growth.
Galderma’s Restylane Shaype gains EU MDR approval for chin augmentation, bringing its high-firmness NASHA HD filler into Europe.
Medtronic has secured an expanded European CE Mark indication for its Affera Mapping and Ablation System with the Sphere-9 catheter, allowing the platform to treat ventricular arrhythmias including ventricular tachycardia and premature ventricular complexes. The August 6, 2026 regulatory expansion moves Sphere-9 beyond the atrial arrhythmias for which the system was initially commercialized. Medtronic describes
FIZE Medical’s CE and UKCA milestones open Europe and Great Britain to FIZE kUO, shifting attention to ICU adoption and clinical evidence.
Sentante is using its CE-marked endovascular robot to capture force, motion and imaging data, but its clinical AI value still needs proof.
Science Corporation launches CE-marked PRIMA in Europe, but reimbursement, specialist training and real-world outcomes will determine access.
Crysvita wins European Union approval for infants from one month, widening early XLH treatment and strengthening Kyowa Kirin’s rare disease franchise.
Medicaroid Corporation has secured European CE marking under the Medical Device Regulation for its Hinotori surgical robot, clearing the Japanese system for commercialisation across European Union member states and certain other markets that recognise the certification. The decision opens another major geography for a platform that has already expanded from Japan into Singapore, Malaysia and
Natera’s Signatera gains European IVDR certification across multiple cancers, opening a new phase for personalized MRD testing and clinical adoption.
Cornerstone Robotics has cleared Europe’s MDR bar for Sentire. The real test is whether surgical robotics can scale beyond elite hospitals.