Aptar Pharma has obtained European CE marking for LuerVax and its optional Spray Divider, establishing a medical device compliance framework for intranasal vaccine administration. The milestone builds on clinical development use of the platform but does not constitute approval of any vaccine delivered through it.
Teleflex completes BIOMAG-LL enrollment in 102 patients, testing longer Freesolve magnesium scaffolds ahead of European regulatory expansion.
Ascensia backs Sava's $36M glucose microsensor push, but clinical validation and CE marking remain critical before its planned European launch.
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.