Cardinal Health Archives - Medical Design Sourcing

FDA issues warning letter to Cardinal Health for adulterated and misbranded medical devices

The FDA recently issued a warning letter to Cardinal Health (NYSE: CAH) + following an inspection at one of its facilities.

The inspection revealed unapproved device violations pertaining to the Monoject Leur-lock tip syringes and the Monoject Enteral Feeding Syringes, as well as quality system regulation violations.

Dublin, Ohio-based Cardinal Health was found to be marketing convenience kits containing certain piston syringes manufactured by Jiangsu Shenli Medical Production Co. without appropriate FDA approvals. The FDA deemed the device adulterated and misbranded under various Federal Food, Drug, and Cosmetic Act sections.

According to the warning letter, syringes with different technological characteristics in the kits posed risks to patient safety, including dosing and device leakage.

Quality system regulation violations led to a recall

Cardinal Health’s quality system regulation violations inc…

The UK wants to deliver medical supplies via drone

[Photo by Jared Brashier on Unsplash]A new proposal from the U.K. Civil Aviation Authority (CAA) set out a plan for medical supply delivery through drone operations.

These proposals are part of the U.K. Future Flight Programme and seek to expand drone capabilities by permitting operations beyond remote pilots’ visual line of sight (BVLOS). The proposed measures involve drones operating at low altitudes and near buildings or infrastructure to minimize conflicts with manned aircraft.

Current drone piloting rules in the U.K require the pilot to have the drone within eyesight, and they are only permitted to fly BVLOS under certain strict restrictions.

“Our proposals are a positive step towards unlocking the next stage for drone flying in the U.K.,” Kevin Woolsey, head of remotely piloted aircraft systems at the U.K. Civil Aviation Authority, said in a news release. “Allowing drones to fly beyond the sight of the remote pilot, without placing r…

How GLP-1s tanked and reshaped the medtech stock market in 2023

Analysts weigh in on how the GLP-1 craze caused one of the biggest swings in the medtech stock market in recent years.

[Image courtesy of Nick Chong on Unsplash]In a tumultuous year for the medtech industry, promising clinical trial results on glucagon-like peptide 1 agonists (GLP-1s) created a seismic shift in the medtech stock market, triggering one of the largest dips in market value that analysts have seen in years.

While analysts said the medtech stock market performed well in 2023 – driven by strong market growth from the backlog of procedures that built up during the pandemic and more innovation and new product launches from companies – the fear of GLP-1s prevailed among investors, sending medtech stocks down significantly in the second half of the year, even as top executives sought to allay concerns.

The specter of GLP-1s such as Novo Nordisk’s Wegovy and Ozempic loomed large, casting doubt on medtech’s future trajectory at the end of the year. However, the stocks have almost fully recovered since then. Analysts predict a rebound in 2024, with diminishing head…

How does medtech CEO compensation compare?

[Image from Unsplash]Medtech CEO compensation averaged $10.5 million during the companies’ most recent fiscal years.

That number from our recent MassDevice analysis may seem like a lot to an average person — but not as much in the world of corporate CEOs.

In fact, the average compensation of S&P 500 company CEOs was $25.2 million in 2022, according to the Economic Policy Institute (EPI), a nonprofit research institute that studies the impact of economic trends and policies on working people in the U.S.

Geoff Martha, who, as CEO of Medtronic, runs the world’s largest medical device company, saw a total compensation of $15.4 million. But look over at the pharmaceutical industry, where revenue numbers are much higher, and the head of the world’s largest pharma company — Pfizer CEO Albert Bourla — brought in $33 million.

As businesses mature into publicly traded companies and revenue grows, it makes sense for CEO compensation to become larger.

BD recalls more Alaris pumps due to compatibility issues with Cardinal Health syringes

The Alaris infusion system. [Image courtesy of BD]The FDA determined that another recall of BD (NYSE:BDX) + Alaris infusion pumps is Class I, the most serious kind.

In the latest Alaris recall, the company cites compatibility issues with Cardinal Health Monoject syringes. The issue mainly relates to changes made to the products by Cardinal Health. It affects more than 1 million total devices.

BD’s Alaris system has been much maligned over the past few years, going back to a Class I recall in early 2020. The recall, which centered around multiple system errors, software errors, and use-related errors, led to a long-term shipping hold on the pumps.

However, the company resumed Alaris distribution after receiving updated FDA clearance in July, seemingly putting those issues in the past.

An FDA notice distributed last week says the company recalled more Alaris pumps this time due to the syringe compatibili…

FDA issues warning about over-the-counter eye drops

The FDA issued a notice warning consumers about 26 over-the-counter eye drop products that could result in eye infections.

In its notice, the FDA instructed consumers not to purchase and to immediately stop using these products. Using those eye drops could lead to the risk of infections that could result in partial vision loss or blindness.

Products included in this warning are marketed under brands such as CVS Health and Cardinal Health’s Leader and Rugby. Rite Aid, Target Up&Up and Velocity Pharma also market affected eye drop products.

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

Cardinal Health launches next-gen neonatal feeding device

Cardinal Health (NYSE: CAH) + announced today that it launched its next-generation NTrainer 2.0 device for neonatal feeding.

Dublin, Ohio-based Cardinal Health designed the NTrainer 2.0 to help premature and newborn infants develop oral coordination skills. These skills — important for a speedy transition to independent feeding — helps to reduce NICU length of stay.

Through real-time assessment technology, NTrainer 2.0 offers clinicians with objective data to track an infant’s progress. It provides parents with confidence on the progress and the potential to thrive after discharge, according to a news release.

Cardinal Health says the system provides key pre-feeding skills in newborns and preterm infants known as non-nutritive suck (NNS). Its design supports proper suck-swallow-breathe coordination in premature infants to reduce time to achieve full oral feeding.

NNS is critical for the safe transit…

What are the largest medical device companies?

Medtronic, Johnson & Johnson MedTech and Siemens Healthineers again lead the Medtech Big 100 list of largest medical device companies.

However, there is so much more to Medical Design & Outsourcing and MassDevice‘s 2023 edition of the Medtech Big 100 report. We pulled thousands of data points to provide information on annual revenue, R&D spending, headcount, CEOs and key leaders, headquarters locations and descriptions of each of the 100 largest medical device companies.

Senior Editor Danielle Kirsh’s analysis shows that even as the largest medtech companies engaged in layoffs over the past year, they also made a bet on innovation to boost future growth: R&D spending increased nearly 13% to $26.4 billion. (Read the full story on MDO.)

In addition, the full Medtech Big 100 list includes already completed medtech company spinoffs such as Embecta , GE HealthCare and ZimVie.

Read the full Medtech Big 100 report to find out …

Cardinal Health sales grow 12.7% in Q3 despite Medical segment declines

Cardinal Health (NYSE:CAH) + shares ticked up today on third-quarter results that beat the consensus forecast.

Shares of CAH rose 1.5% at $82.06 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.5%.

The Dublin, Ohio–based company posted profits of $345 million in the quarter. That amounts to $1.34 per share on sales of $50.5 billion for the three months ended March 31, 2023.

Cardinal Health recorded a massive bottom-line gain from losses of nearly $1.4 billion this time last year. The company posted sales growth of 12.7%. Pharmaceutical sales represented the main growth driver there, rising by 14% year over year. That offset dips in the medical segment, as sales fell by 5% there. Profits in the medical segment slid 66%.

Adjusted to exclude one-time items, earnings per share totaled $1.74. That la…

Cardinal Health says Medical segment profits and sales down in Q2

Cardinal Health (NYSE: CAH) today posted second-quarter results that beat the overall consensus on Wall Street.

The Dublin, Ohio-based company reported losses of $130 million, or 50¢ per share, on sales of $51.5 billion for the three months ended December 31, 2022. Cardinal Health’s results swung to a loss versus the same quarter a year ago. During Q2 2022, it earned $49 million, or 17¢ per share.

Sales in the most recent quarter were up 13%.

Adjusted to exclude one-time items, earnings per share were $1.32, 18¢ ahead of The Street, where analysts were looking for sales of $50.74 billion.

“Our second quarter results demonstrate continued momentum against our plans, led by better-than-expected performance in the Pharmaceutical segment and Medical results in-line with our prior commentary,” CEO Jason Hollar said in a news release. “With the first half of fiscal year 2023 behind us, we are pleased to raise our full-year non-GAAP EPS…

The biggest medtech stock gainers, losers in 2022

(From Ishant Mishra on Unsplash) In another roller coaster year for medtech, these are the companies that saw their stock rise and fall the most drastically.

The MassDevice MedTech 100 Index, which includes stocks of the world’s largest medical device companies, reflects the performance of many in the medtech space.

In a tough year for a lot of businesses, the Index wasn’t immune to struggles. Overall, it dropped 27.3% from this time last year. That compares to a 19.7% drop for the S&P 500 and an 8.9% dip for the Dow Jones Industrial Average.

Some businesses, though, powered through the supply chain- and inflation-related woes to see their stock rise from this time last year. Others weren’t so lucky. Here are some of the biggest gainers and losers — selected from the MedTech 100 Index — of 2022.

Biggest gainers BD — $245.27 to $254.97 — Up 4%

While BD (NYSE:BDX) didn’t have the most significant growth, its stock remains in a …

Cardinal Health names new CFO

Aaron Alt. [Image courtesy of Cardinal Health]Cardinal Health (NYSE:CAH) announced today that it appointed Aaron Alt as its new chief financial officer (CFO).

Alt succeeds interim CEO Trish English, reporting to CEO Jason Hollar. He also joins Cardinal Health’s executive committee, effective Feb. 10, 2023.

Hollar previously served as CFO before taking over the corner office at Cardinal Health in September. English, the company’s chief accounting officer, held the interim role over the past few months.

In the position of CFO, Alt’s responsibilities include leading financial activities across the enterprise. That includes financial strategy, capital deployment, treasury tax, investor relations, accounting and reporting. Additionally, Cardinal Health said he will lead the corporate development team.

Alt most recently served as EVP and CFO for Sysco Corporation. Before that, he was SVP and CFO for Sally Beauty Holdings. Other roles incl…