iRhythm Technologies Archives - Page 3 of 4

FDA clears iRhythm’s ZEUS system for Zio Watch

iRhythm Technologies (Nasdaq:IRTC) announced today that it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system.

ZEUS, produced in partnership with Google’s Verily, combines deep-learned algorithms with iRhythm’s trusted cardiac arrhythmia service, providing the AI algorithm and solution component for the Zio Watch sensor-based wearable for non-invasive, clinical-grade, long-term continuous monitoring for AFib.

According to a news release, Verily also received FDA 510(k) clearance for the Zio Watch (study watch with irregular pulse monitor).

San Francisco-based iRhythm said that ZEUS provides an integrated, prescription-based solution that addresses clinician workflows, care pathways and the patient experience, while the wrist-worn Zio Watch not only detects AFib but also characterizes the amount of AFib over time.

Zio Watch uses a continuous photoplethysmography (PPG), AI-based algorithm to detect AFib and …

iRhythm brings another Dexcom veteran into its C-suite

iRhythm’s next CCO Chad Patterson [Image from Patterson’s LinkedIn page]iRhythm Technologies (Nasdaq:IRTC) announced today that it appointed Chad Patterson as its next chief commercial officer.

Patterson will join the wearable electrocardiogram monitors developer’s executive leadership team and, as CCO, he will oversee the company’s commercial strategy, operations and execution.

He most recently served as chief marketing officer at Dexcom. He will make the move from the continuous glucose monitor developer to iRhythm just as president and CEO Quentin Blackford did in September of 2021.

“As iRhythm expands within its core U.S. markets, into additional international geographies, and into adjacent markets, we are excited to welcome Chad to our executive team,” Blackford said in a news release. “Chad joins us at the perfect time to leverage his experience in driving significant growth in global markets as we look to execute a…

iRhythm brings another Dexcom veteran into its C-suite

iRhythm’s next CCO Chad Patterson [Image from Patterson’s LinkedIn page]iRhythm Technologies (Nasdaq:IRTC) announced today that it appointed Chad Patterson as its next chief commercial officer.

Patterson will join the wearable electrocardiogram monitors developer’s executive leadership team and, as CCO, he will oversee the company’s commercial strategy, operations and execution.

He most recently served as chief marketing officer at Dexcom. He will make the move from the continuous glucose monitor developer to iRhythm just as president and CEO Quentin Blackford did in September of 2021.

“As iRhythm expands within its core U.S. markets, into additional international geographies, and into adjacent markets, we are excited to welcome Chad to our executive team,” Blackford said in a news release. “Chad joins us at the perfect time to leverage his experience in driving significant growth in global markets as we look to execute a…

iRhythm stock up on positive news out of CMS

iRhythm Technologies (Nasdaq:IRTC) stock soared today on positive reimbursement news out of CMS as the agency makes 2023 fee schedule proposals.

Truist analysts yesterday evening pointed to CMS proposing a national coverage determination (NCD) of $229 for the ZioXT wearable cardiac monitor. When incorporating the geographic physician payment adjustments, the analysts thought the actual payment over time to reach over $280.

“We think investors in recent weeks were even potentially bracing for a rate lower than [around] $230, and thus this rate level should serve as a clearing event,” said Truist analysts David Rescott, Richard Newitter and Samuel Brodovsky.

A final CMS rule for fiscal year 2023 is expected around November, according to the analysts.

IRTC shares up more than 22% to $140.99 apiece in midday trading today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — …

iRhythm stays silent on federal grand jury subpoenas

More than one year after receiving the first of two federal grand jury subpoenas seeking information about its products and communications with the FDA, iRhythm Technologies has said little publicly about the matter.

It would have been easy to miss the San Francisco-based cardiac monitor maker’s initial disclosure last summer.

iRhythm (Nasdaq:IRTC) was without a permanent CEO due to Mike Coyle’s sudden resignation in June after four months on the job. IRTC shares seemed to be headed toward historic lows, falling nearly 80% from the start of 2021 as reimbursement rates for cardiac monitoring plunged and then bounced around in a way that one analyst called “beyond bizarre.”

“Investors had vertigo,” Oppenheimer analyst Suraj Kalia said of last year’s pricing drama. “The dizzying pace of what is going on was confusing everyone. And I can tell you, in my 18 years of doing sell-side, I’ve never seen anything like this. Never.”

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iRhythm stays silent on federal grand jury subpoenas

More than one year after receiving the first of two federal grand jury subpoenas seeking information about its products and communications with the FDA, iRhythm Technologies has said little publicly about the matter.

It would have been easy to miss the San Francisco-based cardiac monitor maker’s initial disclosure last summer.

iRhythm (Nasdaq:IRTC) was without a permanent CEO due to Mike Coyle’s sudden resignation in June after four months on the job. IRTC shares seemed to be headed toward historic lows, falling nearly 80% from the start of 2021 as reimbursement rates for cardiac monitoring plunged and then bounced around in a way that one analyst called “beyond bizarre.”

“Investors had vertigo,” Oppenheimer analyst Suraj Kalia said of last year’s pricing drama. “The dizzying pace of what is going on was confusing everyone. And I can tell you, in my 18 years of doing sell-side, I’ve never seen anythin…

iRhythm stock soars on Street-beating Q1; C-Suite changes continue

iRhythm Technologies (NSDQ:IRTC) posted first-quarter results today that beat the consensus forecast on Wall Street and increased its outlook for the rest of the year, sending the stock up nearly 30% in after-hours trading.

The San Francisco-based developer of remote external electrocardiogram monitors reported a net loss of $50.6 million, or -$1.71 per share, on sales of $92.4 million for the three months ended March 31, 2022.

That was a 24.3% increase in sales and a smaller loss than the -$27.8 million (or -$0.95 per share) reported in Q1 2021.

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

iRhythm stock soars on Street-beating Q1; C-Suite changes continue

iRhythm Technologies (NSDQ:IRTC) posted first-quarter results today that beat the consensus forecast on Wall Street and increased its outlook for the rest of the year, sending the stock up nearly 30% in after-hours trading.

The San Francisco-based developer of remote external electrocardiogram monitors reported a net loss of $50.6 million, or -$1.71 per share, on sales of $92.4 million for the three months ended March 31, 2022. That was a 24.3% increase in sales and a smaller loss than the -$27.8 million (or -$0.95 per share) reported in Q1 2021.

“Our strong first-quarter results are indicative of the momentum we carried into 2022 with an acceleration in daily registrations leading to record quarterly volumes,” President and CEO Quentin Blackford said in a news release. “New account openings were up 15% quarter-over-quarter, and we realized significant growth in our core U.S. market. Evidence supporting the clinical superiority of the Zio serv…

iRhythm brings Stanford professor into C-suite

iRhythm Technologies (Nasdaq:IRTC) this week announced it appointed Mintu Turakhia as chief medical officer and chief scientific officer.

Turakhia is a professor of medicine at the Stanford University School of Medicine and the director and cofounder of the Stanford Center for Digital Health. He is also a cardiac electrophysiologist with more than 20 years of experience in patient care, outcomes research and trials, data science and artificial intelligence, medical device regulation and the create and commercialization of digital health products.

According to the company, Turakhia performed the first study of silent atrial fibrillation with iRhythm’s original Zio patch, which helped the company perform large atrial fibrillation studies at scale.

“As healthcare continues to evolve at a rapid pace, we are very excited to add Dr. Turakhia to our executive team,” CEO Quentin Blackford said in a news release. “Mintu is a prolific scientist, respected cl…

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.

Get the full story at our sister site, MassDevice.

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…