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…

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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…

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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.

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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.

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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…

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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…

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iRhythm picks former Dexcom COO Quentin Blackford as new CEO

iRhythm Technologies (NSDQ:IRTC) announced today that it appointed Quentin Blackford as its new president & CEO.

Blackford will assume the role of president & CEO and become a member of the company’s board of directors effective Oct. 4, 2021. The company had been searching for a CEO since June when Mike Coyle announced that he would step down for personal reasons. CFO Douglas Devine has served as interim CEO since Coyle’s departure and will continue to do so until Blackford’s position is made effective next month.

Blackford joins as a veteran of more than 20 years in the medical device and digital health space, most recently serving as COO at Dexcom, having initially joined the diabetes technology developer as CFO in 2017.

Before Dexcom, Blackford served as NuVasive’s EVP, CFO, and head of strategy and corporate integrity. Before that, he held multiple roles at Zimmer Holdings. Blackford is currently an independent member …

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MedTech 100 roundup: Industry reaches another high point

The medtech industry is continuing its massive 2021 boom, with the past week marking yet another record in the markets.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 27) at 121.05 points, representing a 1.2% rise from the 119.63-point mark set a week before. Following a slight dip earlier this month, the industry continues to tick up to new heights.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry remains well above the marks set around the height of the pandemic, having registered a 31.1% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 94.8% ascent above that point.

The industry’s performance fell in line with the overall markets this past week as the S&P 500 I…

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How iRhythm sought to outdo the old-school Holter monitor

iRhythm’s Zio XT cardiac monitor. [Image from iRhythm] iRhythm is changing the game in a heart rhythm monitoring space that has been dominated for years by the Holter Monitor. Here’s how.

About 14 years ago, when Mark Day was interviewing at iRhythm, he could see the unmet needs that a project out of Stanford’s Biodesign program addressed.

While that was a start, there was still a way to go for what would become a massive disruptor in electrocardiograph monitoring and AFib detection.

“While the design and idea was very compelling — and even 14 years later we’re doing very much what that idea was and have brought it to life and are changing the standard of care as a result — the reality was that it was a hockey puck that never would have adhered very long to the chest. It was very much a concept,” Day, who is now iRhythm’s EVP of R&D, told Medical Design & Outsourcing. “Our challenge as medical device professionals was to figure out how to take this conc…

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MedTech 100 roundup: Industry ticks up again

The medtech industry has been rising for weeks and the latest seven-day stretch was no exception as stocks ticked up again.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 6) at 119.41 points, marking a 0.5% rise from the previous week’s tally of 118.86 points (July 30). Not including the  the week in which the index shot up to 145.88 points and quickly tumbled down, the latest marks would represent the index’s all-time best.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 29.3% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 92.2% ascent above that point.

The industry’s performance did not correlate with the overall markets this past week as t…

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iRhythm beats The Street in Q2, expects up to 23% revenue growth this year

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

The San Francisco–based company — maker of the Zio Patch for ambulatory cardiac monitoring — reported a loss of –$17.4 million, or –59¢ per share, on sales of $81.3 million for the quarter ended June 30, 2021. Revenue was up 59.8% year-over-year.

The EPS were 35¢ ahead of The Street, where analysts expected a loss of –94¢ per share on sales of $72.69 million.

“Our second-quarter results reflected continued strong demand for our Zio platform, as well as solid execution on our operating goals. We were pleased to see growth in both total revenues and unit volumes in the quarter, with Zio AT surpassing 10% of our total revenue for the first time,” Doug Devine, iRhythm’s interim CEO and CFO, said in a news release out yesterday evening.

“We also made significant advancements to our technology platform in the second quarter with two n…

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MedTech 100 roundup: Rebound hits a snag

Two weeks ago, medtech was on the rise following a rough stretch, but the past week brought the industry slightly back down to earth.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 4) at 106.96 points, producing a -1.4% dip from the 108.5-point mark set one week prior (May 28). It halts the progress made over a couple of weeks in which the industry produced an uptick, following its 1.4% rise from May 14 to May 21.

Having endured its largest slide of 2021 in recent weeks, the index is still in a better position to produce another upswing after demonstrating signs of picking up again when April brought the industry’s all-time best performance.

Even with setbacks that slowed the industry this past week, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 15.9% rise from the pre…

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