Conavi’s IVUS-OCT System for Intravascular Imaging Cleared by FDA

April 21, 2026—Conavi Medical Corp., a developer of imaging technologies to guide common minimally invasive cardiovascular procedures, announced that it has received FDA 510(k) clearance for its next-generation hybrid imaging system.

Elucid Introduces Lesion Inspection Tool for Plaque-IQ Software Suite

April 20, 2026—Elucid announced the commercial availability of a new lesion inspection tool for coronary and carotid plaque analysis in its Plaque-IQ software suite.

Medtronic Completes Acquisition of CathWorks

April 20, 2026—Medtronic announced it has completed its acquisition of CathWorks, a privately held medical device company focused on the diagnosis and treatment of coronary artery disease with its fractional flow reserve (FFR) diagnostic technology.

Egg Medical Launches EggNest Complete Flex for Apron-Free Radiation Protection

April 9, 2026—Egg Medical announced the launch of EggNest Complete Flex radiation protection, which enables clinicians to safely work apron-free or with ultralight lead aprons.

Philips’ DeviceGuide Cleared for Image Guidance in M-TEER With Edwards’ Pascal Ace System

April 7, 2026—Royal Philips announced it has received FDA 510(k) clearance for EchoNavigator R5.0 with DeviceGuide, an artificial intelligence (AI)–powered software solution that assists interventionists in transcatheter repair procedures of mitral regurgitation.

ALL-RISE Compares CathWorks’ FFRangio to Invasive Pressure Wire Guidance

April 3, 2026—CathWorks announced 1-year clinical outcomes of the ALL-RISE trial.

IVUS-CHIP and OPTIMAL Studies Probe Role of IVUS in Complex PCI and Left Main Disease

March 30, 2026—Routine intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) did not improve clinical outcomes compared with angiography guidance in two contemporary randomized trials presented at ACC.26 and published in The New England Journal of Medicine.

vFFR Demonstrates Comparable Outcome to Standard FFR in FAST-III Trial

March 29, 2026—A novel, minimally invasive method for assessing coronary lesion physiology using vessel fractional flow reserve (vFFR) demonstrated outcomes comparable to conventional fractional flow reserve (FFR) in the randomized FAST-III trial, presented at the American College of Cardiology’s Annual Scientific Session (ACC.26), according to a company press release.

Philips Launches IntraSight Plus Interventional Guidance Platform 

March 30, 2026—Royal Philips announced the launch of the IntraSight Plus interventional guidance platform, which has received FDA 510(k) clearance in the United States and CE Mark approval Europe.

CathWorks’ FFRangio Compared With Invasive Pressure Wire-Guided PCI in Medicare Outcomes Data Through 2 Years

March 9, 2026—CathWorks announced the presentation of outcomes data from a cohort of more than 4,000 Medicare patients demonstrating that angiography-derived physiology (ADP) using CathWorks FFRangio resulted in similar clinical outcomes compared with invasive pressure wire-guided percutaneous coronary intervention (PCI) through 2 years.

Philips’ SmartHeart Planning Solution Gains FDA 510(k) Clearance

March 6, 2026—Philips announced that it has received FDA 510(k) clearance for its SmartHeart, an artificial intelligence- (AI-) powered cardiac MR planning solution that is designed to simplify technically demanding MRI exams.

Salus Scientific Appoints Michael Lankford as Vice President of Sales

March 6, 2026—Salus Scientific Corporation, a developer of radiation protection garments and clinical workflow solutions for fluoroscopy-guided environments, announced the appointment of Michael Lankford as Vice President of Sales.

Abbott’s CardioMEMS Hero PA Pressure Reader Approved by FDA for Remote HF Monitoring

March 2, 2026—Abbott announced FDA approval of the CardioMEMS Hero device, its next-generation pulmonary artery (PA) pressure reader to support the care of patients with heart failure (HF).

FDA Clears Cara Medical’s CTA-Based Platform for Cardiac Conduction System Visualization

February 27, 2026—Cara Medical Ltd. announced that the FDA has granted 510(k) clearance for the Cara system, a CTA-based platform that provides noninvasive, patient-specific three-dimensional (3D) visualization of the cardiac conduction system.

Gentuity Collaborates With GE HealthCare to Market Intravascular Imaging Solutions in the United States

February 27, 2026—Gentuity LLC announced a commercial collaboration with GE HealthCare to increase the availability of Gentuity’s high-frequency optical coherence tomography (HF-OCT) imaging system and Vis-Rx Prime micro-imaging catheter.

AccurKardia’s AK-AVS AI-Enabled ECG Model Detects Aortic Stenosis Years Before TAVR

February 20, 2026—AccurKardia announced results from a new validation study showing that its artificial intelligence (AI)–enabled electrocardiogram (ECG) model, AK-AVS, can identify aortic stenosis (AS) years before patients undergo valve replacement and improve prediction of postprocedural outcomes, according to the company’s press release.

Bracco, ACIST Medical Systems Launch Acist Pro Diagnostic System in Europe

February 12, 2026—ACIST Medical Systems, a Bracco Group company, announced the launch of its Acist Pro diagnostic system in selected European markets after receiving CE Mark under the European Medical Device Regulation.

Salus Scientific AeroShield Radiation Protection Used in First Clinical Case

February 10, 2026—Salus Scientific and Tallahassee Memorial HealthCare (TMH) announced the first clinical use of AeroShield, a table-mounted, inflatable enhanced radiation protection device (ERPD), marking what the organizations described as the first deployment of the technology in a live catheterization laboratory setting.

SCAI Expert Opinion Explores Angiography-Derived Physiology for Coronary Assessment

February 5, 2026—The Society for Cardiovascular Angiography & Interventions (SCAI) announced the publication of an expert opinion document that examines the evolving role of angiography-derived physiology (ADP) for the assessment and management of coronary artery disease.

Medtronic to Acquire CathWorks

February 5, 2026—Medtronic announced it will exercise its option to acquire CathWorks, a privately held medical device company focused on the diagnosis and treatment of coronary artery disease (CAD) with its fractional flow reserve (FFR) diagnostic technology.