iRhythm 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 […]
iRhythm Technologies
New data from iRhythm back the use of long-term ambulatory cardiac monitoring
iRhythm (Nasdaq:IRTC) today announced the presentation of four studies reinforcing evidence behind its long-term cardiac monitoring. San Francisco-based iRhythm presented the data at the Heart Rhythm Society’s annual meeting, Heart Rhythm 2023, in New Orleans. Data supports ambulatory cardiac monitoring of up to 14 days with the company’s Zio XT. It demonstrated increased diagnostic yield […]
iRhythm faces another subpoena from the DOJ
Wearable cardiac monitor developer iRhythm disclosed its third subpoena in more than two years from federal investigators. The news raised some questions from analysts, who were otherwise positive about iRhythm’s first-quarter earnings report yesterday evening. San Francisco–based iRhythm said that on April 4, it received a subpoena duces tecum from the U.S. Department of Justice […]
iRhythm COO resigns amid business transformation
iRhythm Technologies (Nasdaq:IRTC) announced that chief operating officer (COO) Douglas Devine resigned from his position. In an SEC filing, iRhythm attributed Devine’s resignation to its ongoing “business transformation.” His resignation is dated March 10, 2023. In connection with his resignation, Devine entered into a consulting agreement with the company. Under this agreement, he will assist […]
The medtech companies potentially affected by Silicon Valley Bank’s closure
U.S. banking regulators’ latest moves may provide some reassurance for medtech and other companies exposed to Silicon Valley Bank‘s closure. The California Department of Financial Protection and Innovation shuttered SVB on March 10 to stave off what was turning into an old-fashioned bank run. Silicon Valley Bank has been a huge name in the tech […]
The biggest cardiology tech stories from ACC.23
Major medtech players presented a range of intriguing studies at a gathering of some of the biggest names in the cardiology tech space. Some of the hottest topics were covered this past week at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC) in New Orleans. Ablation, cardiac […]
Real-world study backs iRhythm Zio XT
iRhythm Technologies (Nasdaq:IRTC) today announced findings supporting its Zio XT wearable heart monitoring technology. San Francisco-based iRhythm presented multiple new studies at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology (ACC.23/WCC). The Camelot study compared effectiveness of ambulatory monitors for arrhythmia diagnosis. It demonstrated that long-term continuous monitoring […]
iRhythm sees headwinds easing as it enters 2023
iRhythm Technologies (NASDAQ: IRTC) beat The Street on revenue during Q4 amid strong sales and pricing tailwinds for its wearable cardiac monitors. The San Francisco–based company reported yesterday evening that it lost $20.2 million, or 67¢ per share, off of $112.6 million in revenue for the quarter ended Dec. 31, 2022. Revenue was up 37.7% […]
iRhythm sees years of sustainable growth
Wearable cardiac monitor developer iRhythm (NASDAQ:IRTC) saw its stock shoot up today, a day after reporting positive Q4 2022 news. IRTC shares were up more than 10% at $97.26 apiece by midday trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 8%. San Francisco–based […]
The top 10 cardiac device stories of 2022
From pulsed-field ablation to noninvasive monitoring, this was an exciting year for cardiac device tech. Here are the top 10 cardiac device stories from MassDevice and its sister sites: 10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio Earlier this year, Acutus agreed to sell its left-heart access portfolio to […]
iRhythm comments on new national pricing from CMS
iRhythm Technologies (Nasdaq:IRTC) today commented on a recent announcement from the Centers for Medicare and Medicaid Services (CMS). CMS issued its Medicare Physician Fee Schedule (MPFS) Final Rule for Calendar Year 2023. The final rule covers payment policies, payment rates and other provisions for services furnished on or after Jan. 1, 2023. The rule includes […]
