WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

510(k)

Evident Vascular clears its IVUS guidance system for peripheral procedures

MedDevice Startups Staff · 23 hrs ago · 2 min read · Via AuntMinnie

Evident Vascular won FDA 510(k) clearance for its guidance system and the Evident peripheral imaging catheters. The indication covers ultrasound examination of intravascular pathology during peripheral vascular interventions. The San Jose company announced the clearance on November 4.

The catheters are flushless and plug and play. The console runs dynamic frequency control and real time image processing on Nvidia accelerated computing, with an onboard AI workstation. Evident exited stealth in October 2023 with a $35 million Series A led by Vensana Capital, then closed an undisclosed Series B in March 2025.

Founder and board director Justin Klein said the clearance lays a foundation for further FDA submissions. Coronary is where the IVUS volume sits, and a peripheral clearance is the usual way in: same console, same algorithms, a narrower first indication to argue substantial equivalence against.

Questions & Answers

What did Evident Vascular receive FDA clearance for?

Evident Vascular received FDA 510(k) clearance for the Evident Vascular Guidance System and its Evident peripheral imaging catheters, announced November 4, 2026. The system is indicated for ultrasound examination of intravascular pathology during peripheral vascular interventions.

How much funding has Evident Vascular raised?

Evident Vascular exited stealth in October 2023 with a $35 million Series A led by Vensana Capital. It closed a Series B of undisclosed size in March 2025, joined by Shangbay Capital and two undisclosed strategic investors.

Where is Evident Vascular based?

Evident Vascular is based in San Jose, California. Howard Rosen is chief executive and co-founder, and Vensana Capital managing partner Justin Klein is a founder and board director.

← Back to Newly Cleared