iRhythm Technologies Inc. Archives - Medical Design Sourcing

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…

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 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 …

iRhythm wants to be a $1 billion a year company in 5 years

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]iRhythm Technologies (Nasdaq:IRTC) officials think their company’s wearable heart monitoring tech could serve millions more patients, tripling company revenue to more than $1 billion by 2027.

That was a big takeaway from the company’s 2022 Analyst & Investor Day news release today.

“Our technology platform is well suited to meet the needs of an evolving healthcare landscape while transforming a market that has not been disrupted in the last ten years,” said iRhythm CEO Quentin Blackford.

iRhythm today reaffirmed its 2022 guidance, predicting top-line growth of 29–30% to reach $415–420 million. Analysts polled on Yahoo! Finance predicted $418.64 million.

Investors appear to have been looking for more. IRTC shares were down more than 10% to $139.09 apiece in morning trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical d…

iRhythm Technologies stock jumps on Q2 earnings beat

iRhythm Technologies (Nasdaq:IRTC) posted second-quarter results that beat the consensus forecast on Wall Street.

The San Francisco–based developer of the Zio ambulatory cardiac monitor reported a loss of $23.9 million, or $0.80 per share, on sales of $102.1 million for the quarter ended June 30, 2022. Revenue was up 25.6% year-over-year, primarily driven by volume growth of the Zio XT and AT single-use monitors and increases in Medicare pricing.

Adjusted to exclude one-time items, earnings per share were $0.79, $0.12 ahead of The Street, where analysts expected a loss of $0.92 per share on sales of $100.12 million.

“New account openings were up 22% quarter-over-quarter and revenue volumes increased 10% sequentially, underscoring our solid performance amidst a difficult market environment,” iRhythm CEO and President Quentin Blackford said in a news release. “With business highlights regarding reimbursement and our Zio Watch clearance al…

Studies show that iRhythm’s Zio detects AFib early, prevents hospital admissions

iRhythm’s Zio cardiac monitoring device [Image courtesy of iRhythm]iRhythm Technologies (Nasdaq:IRTC) announced results of multiple studies supporting the use of its Zio technology in detecting AFib.

San Francisco-based iRhythm presented the results of three clinical research studies at The American College of Cardiology’s 71st Annual Scientific Session & Expo.

According to a news release, the studies further validate Zio as an option for early AFib detection while also showing that the Zio service can positively impact hospital resources and support the need for monitoring post-transcatheter aortic valve replacement (TAVR) discharge in high-risk patient populations.

The company’s Syncope study found that Zio AT monitored and aided in the diagnosis of qualified syncope patient candidates in an outpatient setting, safely monitoring patients upon discharge to avoid a potential 24-48-hour hospital stay. According to iRhtyhm, 8.2% of patients had an a…

Former CEO Kevin King to retire from iRhythm’s board of directors

iRhythm’s Zio cardiac monitoring device [Image courtesy of iRhythm]iRhythm Technologies (Nasdaq:IRTC) announced today that Kevin King will retire from the company’s board of directors.

King joined San Francisco-based iRhythm’s board in July 2012 and served as the company’s president and CEO from then until January 2021.

“On behalf of the entire iRhythm team, I would like to thank Kevin for his contributions over the last several years,” iRhythm President and CEO Quentin Blackford said in a news release. “iRhythm would not be the company that it is today without Kevin’s leadership and we thank him for the many achievements during his tenure. I am personally grateful to Kevin for him welcoming me into the company and ensuring a smooth transition.”

King led the company, which develops the Zio XT ambulatory cardiac monitor, a wearable ECG device meant to be smaller and more comfortable than a traditional Holter monitor while still offering acc…

iRhythm plans silent AFib screening pilots, high-level hires and Zio Watch evaluations

Verily’s Study Watch will serve as iRhythm’s Zio Watch. [Photo courtesy of Verily]iRhythm Technologies (NSDQ:IRTC) has big plans for 2022 and its remote external electrocardiogram monitors as the medical device developer gears up for growth.

President and CEO Quentin Blackford is looking to hire an international general manager among other roles in the coming months, he told Medical Design & Outsourcing after presenting at this month’s 2022 J.P. Morgan Healthcare Conference, where he laid out his vision for profitably scaling the company.

Blackford also previewed plans to roll out asymptomatic atrial fibrillation (AFib) screening pilots with payors in 2022. Screening for “silent” AFib can detect problems before an event like a stroke or heart failure, giving doctors more time for treatment at a lower cost.

Get the full story at our sister site, Medical Design & Outsourcing.

12 of medtech’s biggest personnel changes in 2021

As medtech companies continued to drive innovation throughout the past 12 months, a number of high-level executives led the way.

Some of those companies and those executives opted for major changes over the course of 2021, though, with some high-profile moves from medtech giant to medtech giant.

Here are some of the biggest personnel moves in the medtech space in 2021:

Get the full story at our sister site, Medical Design & Outsourcing.

iRhythm slides after hours on lowered sales guidance

iRhythm’s Zio XT cardiac monitor [Image from iRhythm]iRhythm Technologies (NSDQ:IRTC) shares took a hit today after the company reported third-quarter results and lowered its 2021 guidance.

The San Francisco-based wearable electrocardiograph patch maker lowered its revenue guidance for 2021 due to unforeseen impacts related to the COVID-19 Delta variant, customer staffing challenges and delayed account launches and expansion. The company’s new range of $317 million to $319 million dropped from a previous estimate of between $320 million and $325 million.

IRTC shares were down 9.4% at $104 per share in after-hours trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — closed the day down 0.2%.

iRhythm posted losses of $23.7 million, or 81¢ per share, on sales of $85.4 million for the three months ended Sept. 30, 2021, for a large bottom-line slide from losses of 4.1 million th…

iRhythm ‘disappointed’ with CMS final rule on wearable ECG patches

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm]iRhythm Technologies (NSDQ:IRTC) issued a comment on the CMS Calendar Year 2022 Medicare Physician Fee Schedule (MPFS) Final Rule.

In the Final Rule, CMS (Centers for Medicare and Medicaid Services) did not issue national pricing and continued carrier pricing for the 2022 calendar year on Category I CPT codes 93241, 93243, 93245 and 93247 for extended external ECG (electrocardiograph) monitoring, the relevant codes for the Company’s Zio XT service.

CMS recommended a $200.15 price (the average of the 10 invoices received by CMS) for such wearable ECG patches but did not set that as the reimbursement level for 2022 as the agency awaits more stockholder feedback.

The company and other industry participants have been working with Medicare Administrative Contractors (MACs) to establish pricing for the codes. iRhythm said in a news release that it remains engaged with all parties to submit additional cost data…