iRhythm Technologies Archives - Medical Design Sourcing

New data from iRhythm back the use of long-term ambulatory cardiac monitoring

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]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 and improved diagnostic accuracy of ventricular arrhythmias across a variety of patient populations.

“These studies thematically showcase the value of iRhythm’s Zio products and services — in particular for identifying ventricular arrhythmias for risk stratification and disease management,” said Dr. Mintu Turakhia, iRhythm chief medical officer, chief scientific officer and EVP, product innovation. “The findings have important clinical and scientific implications, and they further demonstrate the strength of our technolo…

iRhythm faces another subpoena from the DOJ

Wearable cardiac monitor developer iRhythm (Nasdaq: IRTC) + 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 Civil Division’s Consumer Protection Branch. Company officials told analysts that they were fully cooperating. They said it was too early to speculate on the nature or timing of the inquiry.

Analysts noted that Boston Scientific said in its most recent quarterly report that it received a subpoena from the DOJ on April 5 seeking documents and information relating to its ambulatory electrocardiography monitoring (AECG) business. Boston Scientific is also cooperating.

BTIG analysts stuck with their Buy r…

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 with the transition of his role and consult as an executive advisor through July 3, 2024.

Devine and iRhythm also entered into a resignation and release of claims agreement. Pursuant to these terms, he shall receive his base salary and continued standard benefits through the separation date. Devine also received cash severance payments equivalent to his base salary on the separation date for 12 months following that date. He also receives premium payments for continued healthcare coverage for 12 months following separation. iRhythm said it intends to ma…

The medtech companies potentially affected by Silicon Valley Bank’s closure

The California Department of Financial Protection and Innovation today closed Silicon Valley Bank, which could expose medtech companies with relations to the bank.

According to SVB’s website, half of all U.S. VC-backed tech and life science companies used the Santa Clara, California–based bank.

The FDIC — appointed as receiver in the closing — created the Deposit Insurance National Bank of Santa Clara (DINB). This protects insured depositors, the FDIC said in a news release. At the time of closing, the FDIC immediately transferred to the DINB all insured deposits of Silicon Valley Bank.

Silicon Valley Bank’s reach extends to medtech

BTIG analysts issued a list of companies that could be exposed to Silicon Valley Bank. This includes exposure through loan agreements, revolving credit facilities, and more.

The analysts stressed that the list is only based on these companies’ most recent filings. It lacks full additional detail that …

The biggest cardiology tech stories from ACC.23

Medtronic, Abbott, iRhythm and more presented new data at a major cardiology conference, ACC.23. [Images courtesy of Medtronic, Abbott and iRhythm] 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 implants, monitors and imaging technology represented a handful of the technologies on display. Medtronic, Abbott, Boston Scientific, Edwards and more offered new data on their innovative technologies in these areas.

Here are some of the biggest stories that came out of the cardiology conference.

Excitement builds around using pulsed-field ablation to treat AFib

Medtronic, Boston Scientific and Johnson & Johnson MedTech’s Biosense Webster all released new…

Real-world study backs iRhythm Zio XT

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]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 with iRhythm Zio XT is associated with the highest diagnostic yield and fastest time to clinical diagnosis compared to all other ambulatory cardiac monitors (ACMs) when looking at specified arrhythmias.

Additionally, Zio XT demonstrated the lowest likelihood of retesting compared to all other ACMs. It also recorded the lowest acute healthcare resource utilization compared to all other ACMs.

Camelot used real-world Medicare data. It sought to evaluate the yi…

iRhythm sees headwinds easing as it enters 2023

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]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% compared to the same quarter a year ago. Losses were down by more than a third.

Wall Street analysts expected a loss of 62¢ and $110.26 million in revenue.

“We recognized more than 27% revenue growth for the full year, driven by strong volume contributions in addition to pricing tailwinds,” iRhythm CEO Quentin Blackford said in a news release.

“We are also beginning to realize value from our increased focus on operational discipline, achieving positive adjusted EBITDA in the fourth quarter and more than 800-basis points of improvement in adjusted E…

iRhythm sees years of sustainable growth

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]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 iRhythm reported a record number of new account openings for Zio XT heart monitoring patch in the fourth quarter. In addition, the company saw patient registration growth of more than 20% compared to Q4 2021.

CEO Quentin Blackford also pointed to the company successfully working with CMS to secure a national Medicare rate that “positions us well to focus on further market penetration and providing our technology to all patients who may benefit.”

“Despite challenges during 2022, we have made significant progress to advance our mission …

iRhythm sees years of sustainable growth

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]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 iRhythm reported a record number of new account openings for Zio XT heart monitoring patch in the fourth quarter. In addition, the company saw patient registration growth of more than 20% compared to Q4 2021.

CEO Quentin Blackford also pointed to the company successfully working with CMS to secure a national Medicare rate that “positions us well to focus on further market penetration and providing our technology to all patients who may benefit.”

“Despite challenges during 2022, we have made significant progress to advance our mission …

The top 10 cardiac device stories of 2022

[Image from Pixabay]From pulsed-field ablation to non-invasive 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 Medtronic for $50 million.

9. Abbott confirms first implants of its dual-chamber leadless pacemaker system

The company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium.

8. Boston Scientific completes $1.75B Baylis Medical acquisition

The deal expanded Boston Scientific’s electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross transseptal platforms. It also gained a family of guidewires, sheaths an…

iRhythm comments on new national pricing from CMS

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]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 national pricing for Current Procedural Terminology (“CPT”) codes 93241, 93243, 93245, and 93247. It also features an updated price of $260.35 for the extended external ECG patch, medical magnetic tape recorder (SD339) supply item. That benefits the San Francisco-based wearable heart monitor maker.

“The SD339 supply item price of $260.35 in the Final Rule is a positive improvement from the $245.69 price that CMS included in their Proposed Rule issued in July 2022,” the company said. “iRhythm is waiting for the Final Rule and ac…

iRhythm stock dives on reduced full-year guidance

iRhythm Technologies (Nasdaq:IRTC) shares took a hit after hours today on mixed third-quarter results that compared to the consensus forecast.

Shares of IRTC nosedived 17.1% to $105.09 apiece after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 2.1%. (UPDATE: After markets opened, IRTC shares were trading around $117 by mid-day, down about 7%. This may relate to a positive CMS ruling announced today.)

The San Francisco-based developer of wearable heart monitors posted losses of $21.5 million for the quarter. That comes to 71¢ per share on sales of $103.9 million for the three months ended Sept. 30, 2022.

iRhythm recorded a 9.2% bottom-line gain while remaining in the red on sales growth of 21.6%. Staffing and capacity challenges contributed to the company’s results.

Adjusted to exclude one-time items, losses per share totaled 63¢. Tha…