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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Bracco's ACIST Pro Contrast Injection System for Cath Labs

The successor to the ACIST CVi delivers contrast and saline at fixed or variable rates during angiography and can time injections to the heart cycle, according to the FDA summary.

By News DeskMay 18, 20262 min read
Cardiac catheterization laboratory with C-arm X-ray system, procedure table and monitor bank
An empty cardiac catheterization lab with an X-ray C-arm, table and monitors. Not the ACIST Pro system described in this article. Inodayahospitals, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA cleared510(k) · K252653FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • The FDA cleared the ACIST Pro Diagnostic System under 510(k) K252653 on May 13, 2026; ACIST Medical Systems, a Bracco company, announced the clearance and a US launch on May 18.
  • The system is indicated for controlled administration of radiopaque contrast media and saline during angiographic procedures.
  • The 510(k) summary names the ACIST CVi as the predicate and says no clinical testing was required or performed.

The US Food and Drug Administration has cleared the ACIST Pro Diagnostic System, an automated injector that delivers contrast media during heart and vascular imaging procedures, and ACIST Medical Systems, a Bracco company, has begun selling it in the US, Imaging Technology News reported on May 18, citing the companies' announcement.

The FDA's 510(k) database lists the clearance as K252653, a traditional 510(k) from the Eden Prairie, Minnesota, company, received on August 22, 2025, with a substantially equivalent decision on May 13, 2026. The device is classified as an angiographic injector and syringe under product code DXT.

What the clearance covers

According to the clearance letter and 510(k) summary, the system "is indicated for controlled administration of radiopaque contrast media and saline to human subjects undergoing angiographic procedures," the same indication as its predicate, ACIST's own CVi Contrast Delivery System.

The summary describes an injector with two motor-driven pumps, a touchscreen and a processing unit that communicates with X-ray and hemodynamic systems. The pumps deliver contrast and saline through a catheter at a fixed or variable rate set by the user, from 0.1 to 25.0 mL per second and in volumes of 0.1 to 95.0 mL, with injection modes for cardiac, peripheral and structural heart procedures. An optional setting uses the ECG signal from a hemodynamic system to synchronize contrast injection with diastole, the resting phase of the heartbeat.

The system must be used with ACIST's VeraPro disposables, which are covered by a separate 510(k), K252638. Testing cited in the summary includes reprocessing and cleaning, and hardware and software verification and validation. "No clinical testing was required or performed to support this application," the summary states.

Launch and company claims

ACIST said ACIST Pro was first introduced in Japan in 2025 and launched in some European markets after receiving a CE mark under the EU Medical Device Regulation in February 2026.

The company cited published studies of the earlier CVi system that it said showed an average 45 ml reduction in contrast use, a 30 percent reduction in contrast-induced acute kidney injury and an average of five minutes saved per case compared with manual injection. Those figures concern the predicate, not ACIST Pro, and come from the company's announcement.

"Designed for precise delivery of contrast media in interventional cardiology, the system streamlines cath lab procedures with consistently clear images," said Brad Fox, chief executive of ACIST Medical Systems. Fulvio Renoldi Bracco, vice chairman and chief executive of Bracco Imaging, called US availability "an important milestone for our company and for the future of precision imaging in the cath-lab."

The announcement did not give pricing.

Sources

  1. Bracco, ACIST Medical Systems Receive FDA Clearance of ACIST Pro Diagnostic System, Imaging Technology News, May 18, 2026
  2. 510(k) K252653: ACIST Pro Diagnostic System (database record), US Food and Drug Administration, May 13, 2026
  3. K252653 clearance letter and 510(k) summary, US Food and Drug Administration, May 13, 2026