The road to a robot: Medtronic’s development process for Hugo RAS system

[Image from Medtronic]Elephants are the perfect analogy for surgical robotics, Medtronic (NYSE:MDT) VP of Marketing for Surgical Robotics Mike Stow says.

Speaking on the “Road to a robot: Designing technology to address unmet needs & barriers” panel at DeviceTalks Boston last week, Stow explained that elephants are big, taking up a lot of space and that they eat a lot, making them expensive to maintain.

When customers came to Medtronic 10 years ago asking them to consider building a surgical robot, the excessive size and price of maintenance applied to those systems, too.

“We looked at the current state of robotics going back 10-plus years and we realized there was an opportunity for us to come in,” Stow said. “Customers were saying, ‘hey, could you make something more flexible that fits better into our rooms and into our hospital setting?'”

The third comparison of surgical robots and elephants was slight…

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Medtronic’s recall of HawkOne system is Class I

The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind.

So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial software receiving the same classification earlier this month. All recalls confirmed by the FDA this month were initiated by Medtronic in 2021.

The latest recall covers 95,110 HawkOne directional atherectomy systems in the U.S. that were distributed between Jan. 22, 2018, and Oct. 4, 2021. Medtronic initiated the recall on Dec. 6, 2021, having received 163 complaints and 55 reports of injuries with no deaths reported related to the issue.

Medtronic designed HawkOne with a catheter and a cutter driver for use during procedures intended to remove blockage from peripheral arteries and improve blood flow. The rec…

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Medtronic’s Covidien recall of some Puritan Bennett ventilators is Class I

The Puritan Bennett 980 ventilator [Image from Medtronic]The FDA confirmed that the recall of Medtronic’s (NYSE:MDT) Covidien unit’s Puritan Bennett ventilator is Class I, the most serious kind.

Class I designations, the FDA’s most serious classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.

Medtronic’s North Haven, Connecticut-based Covidien unit initiated the recall for the Puritan Bennett 980 Series Ventilator (980A1ENNISB) on Nov. 4, 2021. There were a total of 278 devices in commerce.

The reason for the recall was a manufacturing assembly error in which a capacitor within the ventilator was assembled incorrectly, which could cause the device to become inoperable during use, according to an FDA database.

In response to the issue, the firm began to notify customers of the device defect on Nov. 4. Medtronic said users should remove the affected v…

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DTW Podcast: Zimmer Biomet slims, Corza Medical grows in pursuit of grabbing market share

In this week’s DeviceTalks Weekly Podcast, Rich Newitter, managing director at SVB Leerink, says Zimmer Biomet’s decision to spin out its spinal and dental business will accelerate its already impressive market share grab in its core orthopedics industry.

Dewitter says CEO Bryan Hanson brings a tried-and-true diversification model used by companies like his former employer, Covidien. The spinout of the spinal and dental businesses into a NewCo will allows the company to focus more resources on selling knee and hip implants as well as building out an impressive robotics franchise and a potentially sector-leading line of digital tools and sensors.

“Zimmer has effectively gone from a share loser for almost a decade leading up to when Bryan Hanson took over to a share-taking position,” he said in an interview with Chris Newmarker, executive editor of life sciences. “This most recent quarter, their share gains have widened quite dramatically.”

In …

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