REGULATORY NEWS

ZEISS MEL 90 excimer laser receives U.S. FDA approval

ZEISS Medical Technology has announced that its MEL 90 device has received approval from the FDA, giving the excimer laser technology simultaneous approval for all three major indications, including myopia, hyperopia and mixed astigmatism. Read more

Medtronic achieves CE Mark approval for BrainSense Adaptive deep brain stimulation and Electrode Identifier

Medtronic has announced CE Mark approval in the European Union and the United Kingdom for its BrainSense Adaptive deep brain stimulation (aDBS) and BrainSense Electrode Identifier (EI). Read more

Sequana Medical announces US FDA approval of alfapump

Sequana Medical NV, a specialist in the treatment of drug-resistant fluid overload in liver disease, heart failure and cancer, today announces that it has received Premarket Approval (PMA) from the FDA to market alfapump. Read more

AccurKardia receives FDA breakthrough device designation for AI-powered hyperkalemia detection solution

AccurKardia, an innovator in ECG-based diagnostics technology, has announced that it has received Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its ECG-based, AI-powered AK+ Guard hyperkalemia detection software. Read more

Medtronic receives CE Mark for Endoflip system

Medtronic plc, a global leader in healthcare technology, has announced it has received CE Mark approval for its next generation Endoflip 300 system to measure pressure and dimensions in the oesophagus and pylorus in adults. Read more

Urgent revision of European medical device regulations is ‘positive, timely step’, says expert

The European Parliament has adopted a resolution calling for swift revision of both the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) in response to “the most pressing challenges and bottlenecks”. Read more

Revolutionising High-End Medical Imaging with Advantech SQR-SD5N Integration