Getinge anesthesia systems recall is Class I

[Image from Getinge]The FDA today issued a notice confirming that Getinge’s recall of certain anesthesia systems is Class I, the most serious kind.

Getinge initiated the recall of its Flow-c and Flow-e anesthesia systems (product codes 6887700 and 6887900) due to cracked or broken suction system power switches on May 2, 2022. The systems provide inhalation anesthesia and control the ventilation of patients who have no ability to breathe and can also support the breathing of people with limited ability to do so themselves.

Affected products were distributed between June 2, 2020, and Feb. 15, 2022, according to a news release. To date, the recall has affected 64 devices in the U.S., with a total of 21 complaints, no injuries and no deaths associated with the use of the affected device, according to the notice.

The company received reports of cracked or broken on/of switches on the Flow-c and Flow-e systems’ suction unit. If the on/off switch break…

Read more
  • 0

Getinge wins new infection control contract with HealthTrust

Getinge announced today that national group purchasing organization HealthTrust awarded it an infection control contract.

According to a news release, the HealthTrust contract allows the organization’s members to have access to Getinge’s infection control product portfolio for the first time in more than a decade.

“We are proud that HealthTrust has awarded their respected infection control contract to Getinge,” Getinge North America President Patricia Fitch said in the release. “This will give HealthTrust members easier access to our full breadth of infection control solutions that can help to improve the safety and efficiency of sterile processing departments.”

Getinge’s infection control products, including sterilizers, washers and more solutions, will be offered to HealthTrust members at a contract rate. Such devices are designed to optimize the sterile processing department and improve the speed, efficiency and reliability of the de…

Read more
  • 0

Getinge appoints three new executives

Getinge announced that it appointed three new executives, including a new president of its business for the North America region.

Gothenburg, Sweden-based Getinge confirmed that Patricia Fitch will succeed Eric Honroth as president of the North America region. Honroth has been appointed as president of life science at Getinge.

Additionally, Elin Frostehav, who had been serving as VP of critical care within the acute care therapies business, has been appointed as president of acute care therapies.

Fitch holds more than 30 years of medical device experience, having served in leadership roles in sales, marketing and operations at companies including Johnson & Johnson, Abiomed, St. Jude Medical and 3M.

Honroth joined Getinge in 2018 and has more than 20 years of experience in medical device leadership, with previous positions held at BD, CareFusion and Abbott. He succeeds Harald Castler, who is retiring.

Frostehav joined Getinge in 2019, ha…

Read more
  • 0

Recall of Datascope/Getinge/Maquet intra-aortic balloon pump is Class I

[Image from FDA]The FDA determined that the recall of the Datascope/Getinge/Maquet Cardiosave Hybrid and CardioSave Rescue devices is Class I, the most serious kind.

Datascope/Getinge/Maquet designed the CardioSave Hybrid and CardioSave Rescue intra-aortic balloon pumps (IABP) as cardiac assist devices for patients undergoing cardiac and non-cardiac surgery. They are used in adults who have acute coronary syndrome or complications of heart failure.

Get the full story at our sister site, Medical Tubing & Extrusion.

Read more
  • 0

How medtech fared in the first waves of the pandemic

[Photo by Martin Sanchez on Unsplash]Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data.

Total sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying the ongoing pandemic’s initial toll on the industry.

To compare performance before and during the pandemic, MDO used the financial data that we’ve historically gathered to rank our Big 100 companies in the last three years. The majority of these companies reported full-year results for 2020; others operate on a fiscal year and reported annual results in the first half of 2021.

Some companies are not in this year’s Big 100 but were included in the analysis because they were ranked in pre-pandemic years. The handful of companies that joined this yea…

Read more
  • 0

How medtech fared in the first waves of the pandemic

[Photo by Martin Sanchez on Unsplash]

Medtech industry revenue, research spending and employment declined in the first year of the COVID-19 pandemic, according to a Medical Design & Outsourcing analysis of financial data.

Total sales, R&D spending and employment for the world’s largest medical device companies declined in 2020 and early 2021, according to a Medical Design & Outsourcing analysis tallying the ongoing pandemic’s initial toll on the industry.

To compare performance before and during the pandemic, MDO used the financial data that we’ve historically gathered to rank our Big 100 companies in the last three years. The majority of these companies reported full-year results for 2020; others operate on a fiscal year and reported annual results in the first half of 2021.

Some companies are not in this year’s Big 100 but were included in the analysis because they were ranked in pre…

Read more
  • 0

Getinge adds AI to its OR management software

Getinge announced today that it launched the Torin AI-based operation room management system in the U.S.

Sweden-based Getinge’s Torin software uses AI to quickly and seamlessly improve the speed and efficiency of scheduling surgical procedures. The platform launched in 2020.

The company today introduced a new suite of advanced functions for the platform, expanding its capabilities in key areas, including predicting surgery times, managing waitlists and data security, according to a news release.

“The new capabilities now available with Torin are specifically designed to help hospitals and surgery centers address many areas that are major challenges, including accurate assessments of surgery times, scheduling and waitlist management, applications of mobile devices and data security requirements based on their specific pre-requisites,” Getinge VP of integrated workflow solutions Charlotte Enlund said in the release. “For long-term a…

Read more
  • 0

MedTech 100 roundup: Return to normal following recent spike

After back-to-back all-time best performances, the medtech industry had a slight regression over the course of the last week.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been continuously ticking up 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. However, things have settled down and the industry responded in kind, dipping -1.6% to 112.7 to end last week (April 30).

In spite of the slight decrease over the past week, the industry continues to reflect a bounceback from the struggles brought on by the COVID-19 pandemic.

Overall, has produced a 22.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 81.4% increase from…

Read more
  • 0

DTW Podcast: Can Proximie bring safer surgery to the wider world? How is Getinge answering call for ventilators?

How did Getinge and Proximie respond to the challenges of the pandemic?

In this week’s podcast senior executives from Getinge and Proximie – two very different sized companies – explain how the COVID-19 pandemic accelerated their business.

In the opening keynote conversation, Eric Honroth, president, Getinge North America, explained how the company more than doubled its production of ventilators in 2020. He also discusses recent FDA clearances for two lines of critical devices.

In our closing keynote, Dr. Nadine Hachach-Haram, CEO and founder of Proximie, says the start-up reached its 2023-24 projected size in just a few months as hospitals and medical device companies sought the ability to collect surgeons to the outside world.

Dr. Hachach-Haram, a reconstructive surgeon, gives a detailed account of how a growing shortage of surgeons convinced her to start a technology company.

She also shares how the technology ultimately restored the life of so…

Read more
  • 0

Getinge wins 3 FDA clearances for ventilators

Getinge announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators.

Gothenburg, Sweden-based Getinge’s latest clearances are for new software options for the Servo-u and Servo-n ventilators, as well as clearance for use of the new Servo-u MR ventilator in the MRI room, according to a news release. The three newly cleared products are expected to be made available in the U.S. in July 2021.

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

Read more
  • 0

Getinge wins 3 FDA clearances for ventilators

Getinge announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators.

Gothenburg, Sweden-based Getinge’s latest clearances are for new software options for the Servo-u and Servo-n ventilators, as well as clearance for use of the new Servo-u MR ventilator in the MRI room, according to a news release. The three newly cleared products are expected to be made available in the U.S. in July 2021.

The software upgrades for Servo-u and Servo-n include the automatic stepwise recruitment maneuver, a standardized and automated workflow designed to guide lung recruitment and help clinicians identify a personalized PEEP that provides the lowest driving pressure.

Additionally, the upgrades offer stress index and transpulmonary pressure monitoring, including key parameters for the assessment of lung stress during controlled and spontaneous ventilation, which compliments the lung-protective toolkit that divid…

Read more
  • 0