Australia’s TGA Clears Corindus’ Robotic System
The system enables speedy navigation to a targeted lesion. Read More
BD Recalls Infusion Pumps
The FDA advised users to disconnect the device if infusion occurs at an unexpected rate. Read More
CVS Health Launches Trial of Home Hemodialysis Device
The system makes home dialysis simpler. Read More
FDA Clears Abbott’s Fourth-Generation Valve Repair Device
The device is used in treating mitral valve regurgitation in patients with normal heart valves. Read More
Devices News
FDA Issues Draft Guidance on Labeling of Combination Products
The FDA released draft guidance on the content and formatting of Instructions for Use (IFU) for prescription drugs, biologics, and drug- or biologic-device combinations. Read More
Canada Establishes New Premarket Requirements for Device Cybersecurity
Health Canada issued new guidance on its premarket requirements for medical device cybersecurity. Read More
MedTech Europe Lays Out Plan to Help EU Member States With New MDR
Device association MedTech Europe released a seven-point plan to help EU member states tackle the looming MDR/IVDR implementation deadlines. Read More
483 Roundup: FDA Cites Three Firms for Complaints, Validations
The FDA rapped three devicemakers for a variety of violations including complaint handling, validations and failure to establish procedures for process changes. Read More
