BD launches fully automated microbiology lab robotic track system

BD (NYSE:BDX) introduced its third-generation BD Kiestra total lab automation system.

The next-gen BD Kietstra system includes a new robotic track system that automates lab specimen processing. The result helps reduce manual labor and wait time for results, the company said in a news release yesterday.

Laboratories can create a custom and flexible total lab automation configuration, according to BD. In fact, they can connect multiple BD Kiestra modules, making the system scalable to fit their evolving needs. With multiple track options and a choice of instruments to employ, labs can choose their automation entry point. Then, they configure the system to fit their individual workflow and physical lab space.

“The track-based configuration options are designed to eliminate the manual sorting of plates and walking the specimen from module to module, which helps to ensure culture integrity and results in streamlined workflows,” said Cecilia Sorian…

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BD, CerTest win FDA EUA for monkeypox diagnostic

The BD Max system. [Image from BD]BD (NYSE:BDX) and CerTest Biotec announced today that their monkeypox diagnostic received FDA emergency use authorization (EUA).

Franklin Lakes, New Jersey-based BD and Zaragoza, Spain-based CerTest announced a partnership to develop the test in June. The Viasure monkeypox (Mpox) virus real-time PCR assay works with the BD Max system.

The automated platform, performs nucleic acid extraction and real-time PCR testing. It provides results for up to 24 samples across multiple syndromes in less than three hours, the company said.

The companies made the diagnostic available outside of the U.S. for use in research applications by laboratories in July. They went on to launch it for lab research in the U.S. in September.

“The Mpox outbreak continues to be designated as a global health emergency — the World Health Organization’s highest level of alert,” said Nikos Pavlidis, VP of molecular diagnostics at BD.…

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Michelle Quinn named acting general counsel for BD

Michelle Quinn. [Image courtesy of BD]BD (NYSE:BDX) announced today that it named Michelle Quinn as acting general counsel for the company.

Quinn succeeds Samrat (Sam) Khichi in the role. Khichi informed the company of his intent to depart for a new opportunity, effective Feb. 3, 2023.

Reporting to chair, president and CEO Tom Polen, Quinn holds responsibility for leading the law group at BD. She is also set to become a member of the company’s executive leadership team.

Quinn joined BD in 2019. She currently serves as SVP, deputy general counsel and chief ethics and compliance officer. Prior to that, she served as VP and general counsel of North America for Sandoz, a division of Novartis. Before that, she held the role of VP and associate general counsel at Catalent Pharma Solutions.

“Michelle brings more than two decades as a corporate leader and strategic business advisor, and in the four years since joining BD she has significantly ele…

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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 …

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The 10 biggest diabetes tech stories from 2022

Some of the biggest diabetes technology developments in 2022. These include the Dexcom G7 (top left), Insulet Omnipod 5 (bottom left), Senseonics Eversense E3 (top right) and Abbott FreeStyle Libre 3 (bottom right. 2022 represented a landmark year for next-generation diabetes technologies. Here are the biggest stories from the past year.

Some companies picked up major regulatory nods. Others experienced major regulatory setbacks.

Partnerships were formed and ended, while mergers and acquisitions came and went. There were many stories to choose from, but here are 10 big ones that stood out:

Dexcom G7 receives FDA clearance

The long-awaited regulatory nod for Dexcom’s next-generation continuous glucose monitor (CGM) finally came in December.

Some suggested that San Diego-based Dexcom may pick up clearance as soon as summer 2022. However, a software change recommended by the FDA, plus COVID-19-related backlog, delayed proceedings.

Dexcom COO Ja…

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Embecta stock slides on mixed Q4 results

Embecta (Nasdaq:EMBC) shares dipped before the market opened today on fourth-quarter results that came in mixed compared to the consensus forecast.

EMBC shares fell more than 12% to $29.73 apiece in morning trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 4%.

The Parsippany, New Jersey-based company posted losses of $17.2 million. That amounts to 30¢ per share on sales of $274.6 million for the three months ended Sept. 30, 2022.

Embecta registered a significant bottom-line skid into the red on a sales decline of 8.7%. This time last year — as the diabetes arm of BD — Embecta posted profits of $97.1 million for the quarter. However, Embecta noted that last year’s numbers do not purport to reflect its performance if it were a standalone company.

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

 

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Analysts remain neutral on Embecta, await insulin patch pump developments

BTIG analysts maintained their neutral rating for Embecta (Nasdaq:EMBC) ahead of the company’s fourth-quarter earnings report next week.

Embecta, the BD diabetes spinoff, reports its fourth-quarter earnings on Tuesday, Dec. 20. Analysts Marie Thibault and Sam Eiber also expect 2023 guidance to come from management then.

The analysts mainly expect the patch pump market to dominate discussions, given recent developments in the market. That includes Insulet’s November announcement that it developed a basal-only patch pump for type 2 diabetes. It expects to submit for FDA 510(k) clearance for that technology “soon,” according to company officials.

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

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BD opens $38.6M medication management manufacturing plant in Mexico

BD (NYSE:BD) announced recently that it inaugurated a new $38.6 million manufacturing facility in Tijuana, Mexico.

Government officials from Mexico and Baja, California joined in the opening of the medication management plant. BD plans for the facility to produce devices and technologies that improve medications safety within healthcare settings.

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

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CISA warns on cybersecurity risk with BD BodyGuard infusion pumps

The BodyGuard infusion pump system. [Image from BD]The U.S. Cybersecurity and Infrastructure Security Agency (CISA) today issued an advisory regarding infusion pumps from BD (NYSE:BD).

CISA’s advisory concerns the BD BodyGuard infusion pumps. They may contain a vulnerability in the form of a missing protection mechanism for an alternate hardware interface.

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

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BD beats The Street in Q4 as Medical revenue grows nearly 6%

BD (NYSE: BDX) today reported fourth-quarter results that beat Wall Street expectations. However, its 2023 guidance is less than expected.

The Franklin Lakes, N.J.–based medtech giant earned $287 million, or 92¢ per share, off $4.76 billion in revenue during the quarter ended Sept. 30, 2022. The results represent a bottom-line gain of 8.6% on a top-line cut of 1.8%.

Adjusted to exclude one-time items, BD had an EPS of $2.75. That’s a penny ahead of The Street, where analysts expected EPS of $2.74 on revenue of $4.72 billion.

BD Life Sciences revenue was down 15.9% year-over-year to $1.29 billion in Q4 amid declines in COVID-19 testing revenue. BD Medical, however, was up 5.8% to $2.38 billion amid strong worldwide growth in catheters and vascular care sales.

BD Interventional was up 2.4% to $1.10 billion.

“Fiscal 2022 was another outstanding year with impactful results that confirm the effectiveness of our BD 2025 strategy,̶…

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BD secures ISO certification for its information security management system

BD announced today that it has secured ISO certification for its enterprise-level Information Security Management System.

The Franklin Lakes, New Jersey–based company said the ISMS meets a rigorous set of independently audited international standards. BD says the ISO/IEC 27001:2022 certification demonstrates its commitment to protecting the company, customers and patients from cybersecurity threats.

The International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) established the global ISO/IEC 27001:2022 standard. Certification means an organization is establishing, maintaining and continually improving on its information security systems.

“Cybersecurity continues to be a top priority for Merck and all of health care,” said Michael Harrison, associate director of supplier risk management for Merck.

Harrison added in the BD news release: “As an important supplier to Merck, BD’s ISO 27001 certification demonstra…

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BD secures ISO certification for its information security management system

BD announced today that it has secured ISO certification for its enterprise-level Information Security Management System.

The Franklin Lakes, New Jersey–based company said the ISMS meets a rigorous set of independently audited international standards. BD says the ISO/IEC 27001:2022 certification demonstrates its commitment to protecting the company, customers and patients from cybersecurity threats.

The International Standards Organization (ISO) and the International Electrotechnical Commission (IEC) established the global ISO/IEC 27001:2022 standard. Certification means an organization is establishing, maintaining and continually improving on its information security systems.

“Cybersecurity continues to be a top priority for Merck and all of health care,” said Michael Harrison, associate director of supplier risk management for Merck.

Harrison added in the BD news release: “As an important supplier to Merck, BD’s ISO 27001 certification demonstra…

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