Singulex’ Cardiac Troponin Test Predicts Cardiac Risk In Stable Patients

Results of from a new analysis of plasma samples from an old statin trial suggest that Singulex’ high-sensitivity cardiac troponin test can track the cardiovascular risk in stable patients with ischemic heart disease.

Singulex Inc.’s SMC(Single Molecule Counting) cardiac troponin test can successfully track the risk of worsening cardiovascular disease in stable patients with recent acute coronary syndrome, results of a new study show.

Marc Bonaca of Harvard Medical School, and colleagues in the TIMI Study Group at Brigham And Women’s Hospital in Boston...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Cardiology

Corify Care, Mayo Clinic Join Forces To Advance AI-Driven Global Cardiac Mapping Platform

 
• By 

Corify Care’s CEO said the company aims to submit its 510(k) application to the US FDA by year-end, targeting market clearance in 2026. The company hopes its collaboration with the Mayo Clinic will help speed adoption of ACORYS, a noninvasive mapping technology for use in complex cardiac ablations.

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

Fallouh Healthcare Receives Grant Funding From Innovate UK

 

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

Volta Files For US FDA Approval Of Next-Gen Cardio Mapping Software After Winning Labeling Expansion

 
• By 

Volta Medical received a labeling expansion for its AF-Xplorer mapping software to treat A-fib, which provides the clinical evidence needed to broaden US access. The company hopes for FDA clearance for its improved second-gen AF-Xplorer II software.

More from Device Area

Deaths And Serious Injuries Linked To A Pair Of Heart Device Recalls

 

Two recent recalls from the US FDA involve three deaths linked to an issue with an Abiomed heart pump — as well as three serious injuries related to angiographic catheters from Cook Medical.

‘Be Quick, But Don’t Hurry’: Dexcom CEO Talks CGM Market Success

 
• By 

Dexcom’s CEO Kevin Sayer discusses this fall’s planned launch of the 15-day G7 CGM, downplays Abbott’s dual-sensor while focusing on development of multi-analyte G8, making OTC Stelo app more “consumerish” for Europeans, and more.

New Draft Guidance Clarifies FDA’s UDI Rules For Combination Products

 
• By 

The FDA has released draft guidance clarifying UDI rules for drug- and device-led combination products. The document specifies labeling requirements and makes recommendations to reduce confusion between UDIs and NDCs. Comments are being accepted until Sept. 24.