FDA clears Medtronic’s AI algorithms for cardiac monitoring

Medtronic (NYSE:MDT) announced today that the FDA cleared two of its AccuRhythm AI algorithms for use with the Linq II ICM.

Fridley, Minn.-based Medtronic’s AccuRhythm AI applies artificial intelligence to heart rhythm event data collected by the Linq II insertable cardiac monitor (ICM) in an effort to improve the information provided to physicians for better diagnoses and treatments for abnormal heart rhythms, according to a news release.

The company will present data on the AccuRhythm algorithms for the Linq II ICM at Heart Rhythm 2021 this week.

Medtronic said the now-cleared, cloud-based AccuRhythm algorithms address the two most common ICM false alerts: Afib and asystole. The Afib algorithm reduced false alerts by 74.1% and preserved 99.3% of true Afib alerts, the company noted, while the “pause” algorithm for asystole reduced false pause alerts by 97.4% and preserved 100% of true pause alerts.

“Applying AccuRhythm AI …

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Medtronic launches Prevail drug-coated balloon catheter in Europe

Medtronic (NYSE:MDT) today announced that it has launched its Prevail drug-coated balloon catheter in Europe.

Dublin-based Medtronic designed the Prevail catheter for percutaneous coronary intervention procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease.

Get the full story on our sister site, Medical Tubing + Extrusion.

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How COVID-19 changed medical device clinical trials forever

The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials.

[Image from Unsplash]

DeviceTalks

Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on the quality, safety, and costs of clinical trials? What are the implications for the future?

A panel of experts from across the clinical trial ecosystem discussed these topics on a recent episode of DeviceTalks Tuesdays, sponsored by IMARC.

Panelists included Hamish Baird, clinical research president at Remington-Davis; Brandy Chittester, president of IMARC Research; Xavier Lefebvre, global VP of medical and regulatory operations at Medtronic; and Dr. Eric Kolodziej, corporate VP and global head of quality and regulator…

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Medtronic issues Class I recall of some angiographic guidewires

The FDA classified the recall of some angiographic guidewires made by Medtronic (NYSE:MDT) as Class I, the most serious kind.

Medtronic’s angiographic guidewire component affected by the recall helps place catheters into the vasculature during angiography or other interventional procedures.

According to an FDA notice, the recall occurred because devices were not sterilized before being shipped directly to hospitals. Should patients experience exposure to the non-sterile device, serious adverse events including infection, sepsis and death may occur.

No injuries or deaths have been reported in relation to the issue, which has been the subject of two complaints. The FDA notice says there is potential for underreporting as physicians may not have been aware that the devices were non-sterile.

Medtronic initiated the recall on May 4, 2021, and it encompasses guidewires distributed between Nov. 23, 2007, and March 29, 2021. In total, the company re…

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MedTech 100 roundup: New all-time best reached

Once again, the medtech industry has soared to new heights, eclipsing its all-time best performance by the tiniest of margins.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (July 2) at 114.59 points, coming in just 0.01 points ahead of the 114.58-point mark set in April — previously the industry’s all-time best performance.

The new high mark also represents a 1% rise from the 113.42-point total reached last week (June 25). The industry took a strong June into July, rising nearly 7% over the past four weeks.

Having overcome some recent setbacks, 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 24.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 84.4% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The positive movement in medtech …

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Medtronic announces executive leadership changes

Medtronic (NYSE:MDT) today confirmed two personnel moves within its executive leadership team, with one retirement and a new appointment.

Senior vice president, general counsel and corporate secretary Bradley E. Lerman will retire, having notified the board of directors on June 24 that he planned to step down effective Dec. 31, 2021, according to an SEC filing.

Lerman served on Medtronic’s executive committee for more than seven years and spent more than 40 years in the law field, both in the public sector and private practice. Medtronic said it initiated an internal and external candidate search to identify Lerman’s successor and ensure a smooth transition.

The Fridley, Minn.-based medtech giant also announced the appointment of Jennifer Kirk as its principal accounting officer, global controller and chief accounting officer.

Medtronic’s previous controller recently retired, as did its chief accounting officer, which led the com…

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Medtronic launches its first app-based research study

Medtronic (NYSE:MDT) today announced that it has initiated a Define AFib app-based research study.

The Dublin, Ireland-based company will conduct the atrial fibrillation (AFib) study remotely using data collected from its Linq family of insertable cardiac monitors (ICM) on its Medtronic Discovery App to address questions around AFib burden and its impact on patient outcomes, quality of life and healthcare utilization.

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

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Medtronic launches its first app-based research study

Medtronic (NYSE:MDT) today announced that it has initiated a Define AFib app-based research study.

The Dublin, Ireland-based company will conduct the atrial fibrillation (AFib) study remotely using data collected from its Linq family of insertable cardiac monitors (ICM) on its Medtronic Discovery App to address questions around AFib burden and its impact on patient outcomes, quality of life and healthcare utilization.

Medtronic plans to enroll approximately 5,000 patients who are 22 years or older and have a history of AFib, have an iPhone and one of the Linq ICMs. It will incorporate both device data and patient-reported data from scheduled patient surveys and the HealthKit along with electronic health record information about medications and cardiac procedures. Study data will be used to enable improved AFib management in the future.

“When it comes to managing atrial fibrillation, there is not a one-size-fits-all approach, and the hope is that De…

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Medtronic breaks ground on new campus in Colorado

Medtronic’s new Lafayette, Colo. campus will include two connected five-story buildings. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) broke ground today on a new 400,000 ft2 innovation campus in Lafayette, Colo.

The plan is for roughly 1,100 R&D and administrative employees at the medtech giant’s Boulder and Louisville facilities to move in by the end of next year. Manufacturing will stay in Boulder and Louisville. Medtronic businesses with operations in Colorado include Surgical Innovations, Respiratory Interventions, Patient Monitoring, and Cranial and Spinal Technologies.

Ryan Cos. US will build the Layafette campus on 42 acres — 23 of them developable — constructing two connected five-story buildings.

“Medtronic medical technology developed and manufactured in Colorado transforms patient care globally, and we anticipate continued innovation at our new Lafayette campus,” Medtronic CEO Geoff Martha said in a news release. “We look for…

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DTW Weekly Podcast – Digging Deeper into Cleerly Health $43 million round

In this week’s DeviceTalks Weekly Podcast, we talk with Dr. James Min, the founder and CEO of Cleerly Health, a potentially disruptive diagnostics company that raised $43 million last week. Dr. Min explains how Cleerly Health formed from his work at Weill Cornell Medicine. But, more importantly for entrepreneurs and executives, he walks listeners through the steps he took to prepare for the fund-raising. In our next episode we’ll talk with two VCs who invested in the company to hear why Cleerly’s pitch worked.

We also talk with Jeremy Maniak, the CEO of Minnetronix, which is celebrating its 25th year in business. Maniak shares why medtech is such a draw for quality engineers who want to work for a purpose and work with the top technology. He also takes us through the process that led to Minnetronix creating its own medical device. Maniak, an electrical engineer himself, says Minnetronix will partner with OEMs to sell the device.

Chris Newmarke…

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Medtronic touts trial results for InPen smart insulin pen, extended infusion system

Medtronic (NYSE:MDT) today presented study results for its InPen smart insulin pen and its extended-wear infusion set.

Fridley, Minn.-based Medtronic touted real-world clinical results comparing glycemic outcomes for 1,736 individuals before and after using the InPen smart insulin pen for 90 days with a continuous glucose monitor (CGM).

Get the full story at our sister site, Drug Delivery Business News.

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MedTech 100 roundup: Nearing new highs once again

Having hit a downturn as the summer neared, the medtech industry is now consistently on the rise as June comes to a close.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 25) at 113.42 points, producing a 2.5% rise from the 110.64-point mark set one week prior (June 18). In all, the industry has risen 5.9% over the past three weeks.

The recent upswing shows no signs of slowing after the industry’s progress came to a halt with a -1.4% dip earlier this month. The index looks set to close in on the 114.58-point mark set in April, marking the industry’s all-time best performance.

Even with some recent setbacks, 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 22.9% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 82.6% increase from the mid-pandemic low …

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