Regulatory Approvals

The company recently concluded implantation of the Prima System in patients in the European PRIMAvera pivotal study. Bioelectronics company Pixium Vision has received breakthrough device designation...

FemDx Receives FDA Clearance for Its FalloView Falloposcope The device is the first totally disposable 1.2mm diameter falloposcope incorporating a CMOS chip endoscope. FemDx Medsystems, a...

Surmodics (Nasdaq:SRDX) announced that it received formal feedback from the FDA related to its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodics gave the FDA a...

Vaporox, a Denver based medical device company, has received clearance from the US Food and Drug Administration for its next generation VHT-200 medical device...

The AI-powered app allows for remote monitoring of common Parkinson's disease symptoms such as bradykinesia, tremor and dyskinesia via an Apple Watch. Digital health technology...

Also, Jolly Good has collaborated with Brigham and Women's Hospital to create medical education VR content. Lunit obtains new CE mark for AI DBT solution South...

New artificial intelligence algorithm flags and triages suspected abdominal aortic aneurysms Fourth paragraph, first sentence of release should read: Viz AAA uses artificial intelligence to...

SurgVision, a high-tech company developing pioneering solutions for fluorescence-guided surgical and interventional oncology, part of the Bracco Group, announces that it has received 510(k)...

Using BD's molecular diagnostic platform, the BD Vaginal Panel detects the three most common infectious causes of vaginitis. Becton, Dickinson and Company (BD) has secured 510(k) clearance...