MicroPort Cardio’s Alwide Plus balloon catheter wins CE mark
September 16, 2025
MicroPort CardioFlow said its Alwide Plus balloon catheter has received CE mark approval, clearing the company to market the device in Europe.
MicroPort CardioFlow said its Alwide Plus balloon catheter has received CE mark approval, clearing the company to market the device in Europe.
Roche announced today that it received CE mark for the integration of its Accu-Chek SmartGuide CGM with the mySugr app.
Expanded indication provides patients with knee osteoarthritis with the benefits of Embosphere’s consistent, predictable, and effective clinical results
Novocure (Nasdaq:NVCR) announced today that it received regulatory approval in Japan for its Optune Lua wearable device.
Pulnovo Medical announced today that it received two FDA investigational device exemption (IDE) approvals for its technology.
Breakthrough approval supports home-based testing and strengthens access to care
NAPLES, Fla., Sept. 10, 2025 /PRNewswire/ — Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials.
The trial will evaluate the effectiveness of the nsPFA cardiac surgical system during concurrent surgical procedures.
Neurescue’s device is claimed to be the first catheter to have received a CE mark for addressing non-shockable cardiac arrest.
The company has completed registration and certification for its total disc replacement products, which are now CE-marked.