Regulatory Approvals

Pixium Vision obtains breakthrough device designation for Prima System

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 Medsystems, Inc. Receives FDA Clearance For Its FalloView™ Falloposcope

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 targets FDA premarket approval for drug-coated balloon in Q4

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 Announces FDA Clearance for Its Next Generation Wound Care Medical Device

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...

NeuroRPM obtains FDA 510(k) for Parkinson’s monitoring on Apple Watch

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...

Roundup: Lunit gets new CE mark for AI DBT solution and more briefs

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...

CORRECTING and REPLACING Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm

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 announces that it has received 510(k) clearance from the U.S. Food and Drug Administration for the EXPLORER AIR® II

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)...

BD’s diagnostic test for infectious vaginitis gets 510(k) clearance

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...
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