The FDA expanded the indication for Abbott’s CardioMEMS HF wireless heart failure monitor to include patients who have never been hospitalized for heart failure before.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.
Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.
Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.