New Zealand-based medical device company Toku has secured the CE and UKCA marks for its patented CLAiR technology to evaluate cardiovascular disease (CVD) risk.
The...
The US Food and Drug Administration (FDA) has granted clearance for Hologic’s new Genius Digital Diagnostics System with the Genius Cervical AI algorithm for...
Endogenex has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to commence a pivotal clinical study of the...
NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir...
Tyber Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for an extension to its Mini-Frag System.
The approval introduces additional...
Magstim, the global leader in neuroscience research and treatment for mental health, has been awarded FDA clearance for the Horizon 3.0 with StimGuide Pro....
Element Science, an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients, announced that it has received the European Union’s...
Absolutions Med has received breakthrough designation for an abdominal wall closure device that is intended to reduce the risk of hernia.The Food and Drug...
