DTW Podcast: How Josh Makower wrote the book(s) on medtech innovation

Josh Makower, MD, quite possibly invented modern day medtech innovation.

In this interview, Makower shares his earliest inventions – kind of mind-blowing – and how his early work at Pfizer helped him create the innovation process used today by biodesign programs across the world, including Stanford Biodesign where Dr. Makower will take over as director this fall.

This interview is essential for any individual or organization that wants to innovate. Dr. Makower will share his thoughts on how innovation in any industry should be approached.

This week we’ll explore innovation and social equity. We’ll hear a portion of an interview with Martha Ha, chief privacy officer and chief counsel of corporate governance, and Jon de Csepel, CMO, vice president, medical affairs of the Americas. The pair will explain how the company is reaching out to employees of Asia and Pacific Island and helping them to understand how to better work within the corporate culture. The …

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iRhythm CEO Mike Coyle steps down for personal reasons, shares slide after hours

iRhythm Technologies (NSDQ:IRTC) announced today that president & CEO Mike Coyle resigned effective today due to personal matters.

San Francisco-based iRhythm said in a news release that CFO Douglas Devine will take over as interim CEO while the search for a permanent replacement for Coyle is conducted. The company’s board of directors formed a CEO search committee and retained a search firm to assist in the process.

Coyle agreed to support a well-ordered transition of his responsibilities to Devine and will provide consulting services to the company, centered around reimbursement matters, until a permanent CEO is named. Coyle left Medtronic in December 2020 to take over as CEO of the AI-powered heart monitor developer in January of this year.

Shares of IRTC closed the day up 1.1% at $76.25 per share but, following the news release regarding Coyle’s departure, were down -11% at $67.90 apiece after hours.

iRhythm chairm…

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iRhythm wins FDA clearances for cardiac monitoring devices

iRhythm Technologies (NSDQ:IRTC) announced that it received FDA 510(k) clearances for to updates to its technologies.

San Francisco-based iRhythm’s first clearance came for a new and improved design of its flagship Zio monitor and the second covered updated artificial intelligence (AI) capabilities, according to a news release.

The new monitor for the Zio ambulatory cardiac monitoring patch for detecting Afib offers increased adherence and better patient comfort, the company said. Its size allows for patients to forget they are wearing it during exercise, showering and sleeping, while the design is 50% lighter than the current generation with a breathable and waterproof outer layer.

Additionally, the monitor includes a “stay-put” adhesive and a flexible design for secure attachment, allowing for a more comfortable wear and more accurate diagnostic data, iRhythm said.

“iRhythm started with the patient in mind first,” iRhythm chief…

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MedTech 100 roundup: Largest slide for industry in 2021

The medtech industry’s 2021 performance has been all over the place and the past weekend highlighted its topsy-turvy nature.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been on the rise since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index topped itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week.

After a -1.6% decrease over the week ending on April 30, there was little indication of in which direction the index would head next. The industry’s response to the slight dip was an even sharper downturn with a 4.49-point loss.

On May 6, the index finished the day at 108.21, representing a -4% slide from the previous week’s mark and a -5.6% fall from the high-point set the previous week. Th…

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iRhythm Technologies ticks up before hours on mixed-bag Q1 results

iRhythm Technologies (NASDAQ: IRTC) posted first-quarter results yesterday that missed the earnings consensus on Wall Street but beat the revenue projections.

The San Francisco-based company reported losses of -$27.8 million, or -95¢ per share, on sales of $74.3 million for the three months ended March 31, for a sales growth of 16.96% compared with Q1 2020.

Earnings per share were -95¢, 12¢ behind The Street, where analysts were looking for sales of $70.3 million.

“The clinical and economic value of our Zio service continues to drive strong demand and generated record volumes in the first quarter. Volumes were 31% above pre-COVID levels seen in the first quarter of 2020, powered primarily by Zio XT in the U.S., while Zio AT in the U.S. and Zio XT in the UK outpaced overall company growth on a percentage basis,” president and CEO Mike Coyle said in a news release. “As we look forward, our differentiated technology and the enthusiasm we are seeing from bot…

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DeviceTalks Weekly Podcast – iRhythm CEO Mike Coyle, New Podcast!

In this podcast, iRhythm CEO Mike Coyle discusses his decision to join the digital health leader in January.

Coyle’s had to hit the ground running as iRhythm manages some challenging decisions from regional Medicare payors but he also sees great opportunity for the company’s ZIO platform across the healthcare spectrum.

In this conversation, Coyle discusses

How he came to join the Medtech industry. The potential for its ZIO cardiac monitoring technology How the company is dealing with a disappointing reimbursement How the company will pursue the large asymptomatic market What’s expected to come from the company’s partnership with Verily

We also introduce the newest member of our DeviceTalks Podcast family! Catch an excerpt of the first episode in this week’s podcast. Subscribe to hear future episodes.

Caffeine-fueled Chris Newmarker, executive editor of life sciences at Mass Device, takes a break from earnings week to roll out a powerful #newmark…

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MedTech 100 Roundup: Small slide continues

On the back of several weeks of new records and strong performances, the medtech industry has finally hit a snag in its recent ascent.

MassDevice‘s MedTech 100 index ended the week (Feb. 26) at 106.65 points, marking a 1.9% dip from the 108.72-point mark set one week before (Feb. 19). This highlights a similar drop from the week prior, when the index slid -1.7% from 110.63 points on Feb. 12.

The slide for the index was inevitable, given the heights to which it had been rising, but it is stark after exactly two weeks ago, on Monday, Feb. 15, the index hit its highest mark ever, though, rising to 110.96 points. That mark set an all-time best for the index, which had previously been rising for practically all of 2021. The index had never reached even the 100-point mark before November 2020.

Still, the industry is in much better condition than it was around this time last year. Medtech’s latest mark means the index has risen 15.5% from the pre-COVID-19 pande…

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iRhythm’s revenue jumps 33% in Q4

iRhythm Technologies (NASDAQ: IRTC) today reported mixed Q4 results but predicted strong sales growth in 2021.

The San Francisco–based company — maker of the Zio ambulatory cardiac monitoring patch — reported a loss of –$9.7 million, or –33¢ per share, on sales of $78.8 million for the three months ended Dec. 31, 2020, nearly halving its losses on 33% sales growth compared with Q4 2019.

The earnings were 2 pennies behind The Street, where the analyst consensus was a loss of –31¢ per share on sales of $76.57 million.

“Once again, fourth-quarter results were driven by further penetration of Zio XT in both existing and new accounts, continued ramp of Zio AT and continued utilization of our Home Enrollment service in telemedicine settings,” said iRhythm CEO Mike Coyle.

Due to continuing uncertainties in reimbursement, the company isn’t able to provide revenue or margin guidance, but Coyle in this evening’s news release mentioned cont…

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iRhythm Zio 10 times more effective in identifying Afib, study says

iRhythm Technologies (NSDQ:IRTC) today touted study results that found its Zio device was more effective in detecting Afib than standard care.

Published in JAMA Cardiology, the SCREEN-AF study showed that the use of Zio by iRhythm led to a tenfold increase in the detection of Afib when compared to patients receiving standard clinical care. One of every 20 patients in the heart monitoring group was found to have a new diagnosis of Afib and, as a result, 75% of such patients were subsequently prescribed blood thinner medication to prevent against strokes, according to a news release.

San Francisco-based iRhythm said the study supports the use of Zio as a screening tool for the early detection of Afib, as the system was well-tolerated and effective while enabling some patients to receive anticoagulant therapy.

News of the system’s effectiveness in the study is another boost for the company, which, in December 2020, announced that the Zio XT ambulatory…

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MedTech 100 roundup: Rise to new heights continues

The medtech industry hit another high as 2021 continues to bring strong performances out of some of the biggest companies around.

MassDevice‘s MedTech 100 index ended the week (Feb. 12) at 110.63 points, marking a 2.2% rise from the 108.23-point mark set at the end of the previous week (Feb. 5).

The final mark for the week sets an all-time best for the index, which had previously reached 106.81 points on Jan. 8, then 107.4 points on Jan. 20 before besting itself again with last week’s finish. The rise has been considerably impressive given that the index had never reached even the 100-point mark before November 2020.

Medtech’s latest rise means the index has risen 19.8% from the pre-COVID-19 pandemic high of 92.32, set on Feb. 19, 2020. Additionally, the industry has very much rebounded from its lowest place, a 62.13-point mark at the start of the pandemic on March 23, 2020. Since that point, the industry has jumped 78.1%.

Medtech’s performa…

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DTW #45: Kamen talks 3D organs; Todd Pope returns as CEO; Joe Mulling says Medtech’s time is now

Please lift this jam-packed episode with your legs, not your back.

We’ll hear inspirational words from the legendary Dean Kamen who is shifting his life’s focus into medtech. WellAir’s Todd Pope takes the CEO seat at a new company built to tackle hospital-acquired-infections and COVID Joe Mullings of the Mullings Group explains why now is the best time to be in the Medtech industry.

Chris Newmarker, executive editor of life sciences, delivers a murderers row of #newmarkersnewsmakers with Philips, Medtronic, iRyhthm, Canary Medical and Apollo Endosurgery.

To hear Dean Kamen’s entire interview with Design World’s Paul Heney go here.

Don’t miss a future episode! Subcribe now!

DeviceTalks by MassDevice · Dean Kamen eyeing 3D organs; Todd Pope talks clean air; Joe Mullings says Medtech’s time is now
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How new CEO Mike Coyle plans to lead iRhythm forward

Image from iRhythm

Taking over as CEO of a medtech company in the midst of a pandemic doesn’t seem ideal, but former Medtronic executive Mike Coyle was thrilled to take the helm of iRhythm Technologies (NSDQ:IRTC) in January 2021. The company had had a banner year in 2020, and Coyle believes it has a bright future in a space that continues to grow.

“I always had an ambition to be a CEO of a public company and, when this opportunity came along, I was really impressed with the team that’s here,” Coyle told Medical Design & Outsourcing recently. “This just seemed like the right time to make the move and I couldn’t be more excited about what’s ahead, especially the fact that, despite the strong growth the company’s had over the last several years, I think it’s just on the front end of continuing to drive disruption in the U.S. market.”

iRhythm’s strength in the cardiac arrhythmia detection and treatment space was on display in 2020, as the company’s stock nearl…

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