iRhythm Archives - Page 2 of 2 - Medical Design Sourcing

iRhythm has an FDA warning letter over Zio AT quality systems

The Zio AT mobile cardiac telemetry device [Image courtesy of iRhythm]iRhythm (Nasdaq: IRTC) + stock is down today on news of an FDA warning letter involving its Zio AT mobile cardiac telemetry device.

In a Form 8-K filed with the SEC yesterday, iRhythm said it received the warning letter on May 25. The warning letter resulted from an FDA inspection at the company’s Cypress, California facility that concluded on August 2022.

The warning letter alleged that iRhythm was not conforming to medical device reporting requirements related to its Zio AT and medical device quality system requirements, according to the company’s SEC filing. (The actual letter is not yet available on the FDA’s website.)

Said iRhythm: “The company takes these matters very seriously. The company intends to respond within the specified time period and work diligently to address the FDA’s concerns.”

IRTC share…

The top cardiac care innovation news at Heart Rhythm 2023

The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting.

Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide.

Boston Scientific, Abbott, Medtronic, Philips, and iRhythm unveiled advances that have the potential to revolutionize the field of cardiology and improve patient outcomes.

The cardiology devices showcased at the Heart Rhythm 2023 hold promise for the future of cardiovascular care. As these innovations continue to advance, they have the potential to significantly improve the lives of patients worldwide. Stay tuned as we delve deeper into the details of these groundbreaking technologies and their impact on the field of cardiology.

Get the full story on o…

The top cardiac care innovation news at Heart Rhythm 2023

The future of cardiac care was on display at the Heart Rhythm Society’s 2023 annual meeting.

Medical device companies showcased groundbreaking technologies at Heart Rhythm 2023, May 19-21 in New Orleans. The innovations presented during the event offer new avenues for diagnosis, treatment, and monitoring of cardiovascular conditions, providing hope for patients worldwide.

Boston Scientific, Abbott, Medtronic, Philips, and iRhythm unveiled advances that have the potential to revolutionize the field of cardiology and improve patient outcomes.

The cardiology devices showcased at the Heart Rhythm 2023 hold promise for the future of cardiovascular care. As these innovations continue to advance, they have the potential to significantly improve the lives of patients worldwide. Stay tuned as we delve deeper into the details of these groundbreaking technologies and their impact on the field of cardiology.

Here’s a roundup of Associate Editor Se…

Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…