FDA clears Boston's heart rate variability test:

Boston Medical Technologies has received US FDA 510(k) clearance to expand the use of its heart rate variability test to detect autonomic nervous system dysfunction, a condition prevalent in patients with chronic diseases, such as diabetes. The Anscore health management system, which assesses and documents a patient's heart rate variability in response to paced respiration and other controlled exercises, was originally cleared for heart rate variability testing in 1999, said the Wakefield, Massachusetts company.

Boston Medical Technologies has received US FDA 510(k) clearance to expand the use of its heart rate variability test to detect autonomic nervous system dysfunction, a condition prevalent in patients with chronic diseases, such as diabetes. The Anscore health management system, which assesses and documents a patient's heart rate variability in response to paced respiration and other controlled exercises, was originally cleared for heart rate variability testing in 1999, said the Wakefield, Massachusetts company.

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 Archive

More from Medtech Insight

EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By 

The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

European Medtechs Reiterate Opposition To Reciprocal Tariffs On US Imports

 
• By 

EU countermeasures against US tariffs suggest medtech categories exported to the EU could be targeted for tariffs. MedTech Europe and the German IVDs industry have stressed the negative effects this would have on patient care.

Ceryx Medical Amasses £11M To Develop Adaptive Cardiac Pacing Technology

 

The Development Bank of Wales and London-based Parkwalk Advisors led an investment round of £5m, almost doubling Ceryx Medical's total investment to date.