Regulatory Approvals

Onward Medical announced today that it received FDA 510(k) clearance to expand the ARC-EX system’s indication for home use. ARC-EX spinal cord stimulation (SCS)...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Augmedics’ new augmented reality (AR) headset, X2, designed for use with the...

ViTAA Medical’s aortic surgery planning tool has gained clearance from the US Food and Drug Administration (FDA), representing the first milestone in the company’s...

Zap Surgical’s ZAP Axon radiosurgery planning system has received 510(k) clearance from the US Food and Drug Administration (FDA), as well as gaining the...

Nitinotes, a medical device company transforming the treatment of obesity, today announced it has received CE Mark approval for the EndoZip System, the first...

Medical Microinstruments (MMI) announced it received FDA investigational device exemption (IDE) to study its microsurgery platform. The FDA granted the IDE for a clinical study...

RevealDx, a leader in the characterization of lung nodules, announces MDR Certification of RevealAI-Lung. The RevealDX product, RevealAI-Lung, characterizes nodules by producing a score called...

Aqua Medical has received investigational device exemption (IDE) from the FDA for its ablation device aimed at treating diabetes. The IDE gives the device...

Pulsenmore’s at-home ultrasound platform, Pulsenmore ES, has received de novo authorisation from the US Food and Drug Administration (FDA). Pulsenmore ES enables pregnant women to...