FDA expects longer AED shortage, reports plans for Abbott HeartMate II discontinuation

The FDA now expects shortages of automated external defibrillators (AEDs) to persist longer than previously estimated, but removed four other product types from its list of medical device shortages.

The agency also added to its list of discontinued devices, including plans by Abbott to stop manufacturing its HeartMate II Left Ventricular Assist System (LVAS) in 2026.

AED shortage update

The FDA said shortages of wearable and non-wearable AEDs (product codes MVK and MKJ, respectively) will likely last through summer 2024. The federal agency updated its forecast last month after saying as recently as October that the shortage would last through 2023.

The FDA said the shortages are due to an increase in demand for the devices as well as a shortage or discontinuance of a component, part or accessory. Those devices have been on the shortage list since July 2022 as the agency required manufacturers to file for premarket approval (PMA) for previously cleared ac…

Read more
  • 0

ICU Medical stock falls on Q3 revenue miss

ICU Medical (Nasdaq: ICUI) + stock is down today after a third-quarter earnings report that included a revenue miss. 

ICUI shares were down more than 15% to $86.68 apiece by midday trading today. MassDevice‘s MedTech 100 Index was down slightly.

San Clemente, California–based ICU Medical — maker of infusion systems, infusion consumables and critical care products — announced yesterday evening that it earned $7.2 million, or 30¢ per share, off of $553.3 million in revenue for the quarter that ended Sept. 30, 2023. The bottom line swung to the black compared with a loss of $13.2 million in Q3 2022. However, revenue was down more than 7%.

Adjusted to exclude one-time items, ICU Medical saw an EPS of $1.57. The result was 19¢ ahead of The Street, where the analyst consensus expected EPS of $1.38 on sales of $565.75.

ICU Medical CEO Vivek Jain said in a news release: “Third quarter results were generally…

Read more
  • 0

FDA clears new infusion pump and software from ICU Medical

The Plum Duo infusion pump with LifeShield infusion safety software. [Image courtesy of ICU Medical]ICU Medical (Nasdaq: ICUI) + announced today that the FDA granted 510(k) clearance to its Plum Duo infusion pump with LifeShield infusion safety software.

The San Clemente, California-based company plans to make the pump and software available to U.S. customers in early 2024.

Plum Duo, the latest addition to the ICU Medical infusion device portfolio, builds on the cassette technology in the Plum 360 system. It features a large color touch screen with a highly intuitive user interface. With two channels, the system can deliver up to four compatible intravenous (IV) medications.

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

Read more
  • 0

ICU Medical to close Minnesota facility, cut 81 jobs

ICU Medical (Nasdaq: ICUI) + filed with the state of Minnesota to confirm a facility closure and some layoffs.

Layoffs continue to impact the medtech industry as companies battle ongoing economic challenges. Over the past year or so, MassDevice has reported on around 18,000 job cuts across the industry.

Minnesota’s State Rapid Response Team received a Worker Adjustment and Retraining Notification (WARN) letter from ICU Medical dated Aug. 17. It informed the state of the permanent closure of a plant and layoff of approximately 81 employees. The manufacturing facility is located in Oakdale, just east of St. Paul.

Due to changes in manufacturing operations at the Oakdale facility, plus other U.S. operations, ICU Medical plans for layoffs to begin on Oct. 29, 2023. It plans for a full business closure on Dec. 31, 2024.

According to the ICU Medical letter, employees are not repr…

Read more
  • 0

ICU Medical recalls certain infusion pump replacement batteries

The Plum 360 infusion system. [Image from ICU Medical]The FDA issued a notice determining that the recall of ICU Medical (Nasdaq:ICUI) infusion pump batteries is Class I, the most serious kind.

ICU Medical initiated a recall of replacement batteries for certain infusion systems on March 22, 2023. The recall affects its Plum 360, Plum A+ and Plum A+3 infusion systems.

The infusion systems provide fluid to patients in precisely controlled infusion amounts and rates. They deliver blood or blood products, drugs and other fluid mixtures through subcutaneous, intramuscular, intravenous, and intrathecal administration. Their batteries and replacement batteries are used when the pump is not plugged into AC power. An example of this occurs during patient transport.

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

Read more
  • 0

Medtech jobs: The world’s largest medical device companies are hiring

Medical device companies are trying to fill thousand of medtech jobs. [Photo by ijeab – stock.adobe.com]

The world’s largest medical device companies are still hiring for medtech jobs despite layoffs in tech and other industries.

Medtech developers — and medtech jobs — are resilient, with the industry’s COVID-19 pandemic performance only bolstering its recession-proof reputation.

That’s not to say there haven’t been job cuts in medtech, led by thousands of layoffs at Philips as it struggles with a massive recall of deadly respiratory devices. But most medical device manufacturers are still hiring, and in some cases they can’t attract enough candidates to fill every vacancy in a tight labor market.

Stryker, for example, grew to approximately 51,000 employees as of the end of 2022, increasing its headcount by nearly 11 percent last year. Boston Scientific reported nearl…

Read more
  • 0

ICU Medical stock slides on mixed Q4, projected 2023 losses

ICU Medical (Nasdaq:ICUI) shares took a hit today on fourth-quarter results that came in mixed compared to the consensus forecast.

Shares of ICUI fell 6.2% at $166.70 apiece just after the market opened today.

The San Clemente, California-based company posted losses of $15.5 million in the quarter. That amounts to 65¢ per share on sales of $578 million for the three months ended Dec. 31, 2022.

ICU Medical recorded a large bottom-line slide into the red, having posted profits of nearly $20 million this time last year. However, fourth-quarter sales massively improved year-over-year, growing by 69.7%.

Adjusted to exclude one-time items, earnings per share totaled $1.60. That landed 4¢ ahead of projections on Wall Street. Despite the earnings beat, sales fell just short of expectations, as analysts forecast $582.9 million in revenue.

“Legacy ICU Medical revenues were in line with expectations and results from the acquired Smiths Medical busines…

Read more
  • 0

Smiths Medical issues urgent device correction for some CADD infusion pumps

Smiths Medical today issued an urgent medical device correction letter to inform customers of potential issues with its CADD infusion system.

The company — which ICU Medical acquired in January for $2.35 billion — identified two potential issues with the infusion sets. They relate to the potential lack of delivery or underdelivery and false no disposable attached (NDA) alarms.

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

Read more
  • 0

10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

Read more
  • 0

ICU Medical stock sinks on Q2 misses, slashed 2022 guidance

ICU Medical (Nasdaq:ICUI) shares took a hit on second-quarter results that came up shy of the consensus forecast.

Shares of ICUI were down 6.4% at $176 per share before the market opened today. They had closed yesterday up 4.7% at $188.10 per share.

The San Clemente, California-based company posted losses of $7.5 million, or 31¢ per share, on sales of $561 million for the three months ended June 30, 2022, for a sizeable bottom-line slide into the red despite sales growth of 74.4%.

Adjusted to exclude one-time items, earnings per share were $1.37, 49¢ behind Wall Street, where analysts were looking for sales of $565.1 million.

“Legacy ICU Medical revenues were in line with expectations and results from the acquired Smiths Medical business reflect improvement over the course of the second quarter,” ICU Medical CEO Vivek Jain said in a news release.

ICU Medical made large cuts on in its 2022 full-year guidance, reducing adjusted EBITDA p…

Read more
  • 0

ICU Medical beats The Street in Q1

ICU Medical (Nasdaq:ICUI) reported first-quarter results that came in ahead of the consensus earnings per share forecast.

The San Clemente, California-based company posted losses of $38.1 million, or $1.61 per share, on sales of $543.1 million for the three months ended March 31, 2022, for a bottom-line slide into the red on sales growth of 70.8%.

Adjusted to exclude one-time items, earnings per share were $1.82, 4¢ ahead of projections on Wall Street, where analysts were looking for sales of $543.1 million.

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

Read more
  • 0

These 10 medtech companies’ stocks performed best in 2021

(From Ishant Mishra on Unsplash)

Following a year like no other in 2020, 2021 was when many looked to rebound — including the medtech industry.

A number of medtech companies followed up a challenging, pandemic-enveloped year with impressive performances. Plenty of them had already proven in 2020 that they were capable of a quick bounce-back.

Here are 10 medtech companies that saw their stocks soar even higher in 2021:

(This list includes members of the MassDevice MedTech 100 Index of the world’s largest medical device companies. Performance is measured in stock price change from Dec. 31, 2020, to Dec. 31, 2021.)

Get the full story at our sister site, MassDevice.

Read more
  • 0