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FDA clears updated BD Alaris infusion system after long-term commercial hold

The Alaris infusion system. [Image courtesy of BD]BD (NYSE: BDX) + announced today that the FDA granted 510(k) clearance for its updated Alaris infusion system.

Shares of BDX closed out Friday evening priced at $264.84 each. They ticked up significantly after market close on the back of the Alaris news, rising 5.9% to $280.40 apiece.

Clearance enables both remediation and a return to full commercial operations for the previously maligned infusion system. It covers updated hardware features for the point-of-care unit (PCU), large-volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules.

The updated clearance also covers a new software version with enhanced cybersecurity, plus interoperability features. These enable smart, connected care with the most widely used electronic medical record (EMR) systems.

“The 510(k) clearance of the upda…

8 drug delivery innovations you should know

Innovations in drug delivery never stop and, over the past 12 months or so, a wide variety have come under the spotlight.

Constant progress continues in the diabetes space, both in the form of insulin delivery and other drug delivery methods. Elsewhere, we see implants, patches, syringes and more showcasing just how many ways we can deliver therapeutics.

About a year ago, we clued in readers to a list of six drug delivery innovations they should know. Here, we provide a couple of updates on those and try to introduce a few more developments that you should know:

The latest in automated insulin delivery tech

Automated insulin delivery represents one of the most high-profile markets in drug delivery, with the technology providing potentially life-saving therapy for people with diabetes.

The Mobi automated insulin pump with the accompanying mobile app. [Image courtesy of Tandem Diabetes Care]Last year’s roundup included the already FDA-cleared Omn…

BD discloses 8 cybersecurity vulnerabilities with Alaris infusion system

The Alaris system with Guardrails Suite MX. [Image courtesy of BD]BD (NYSE: BDX) + today voluntarily posted a product security bulletin for a number of vulnerabilities with its Alaris infusion system.

Franklin Lakes, New Jersey-based BD recently identified eight vulnerabilities. These vulnerabilities are associated with the BD Alaris system with Guardrails Suite MX, versions 12.1.3 and earlier.

The company discovered the vulnerabilities through routine internal security testing as part of its software development life cycle. This includes vulnerability scanning, code analysis, threat modeling and penetration testing.

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

BD is cutting 60 jobs at Ireland facility

BD (NYSE: BDX) + announced plans to eliminate 60 positions at its manufacturing facility based in Drogheda, Ireland.

A statement provided by a BD spokesperson confirmed a targeted reduction of 60 positions due to a combination of factors. These include the effects of the COVID-19 pandemic and the company’s spinoff of its diabetes business, Embecta.

The company announced the creation of 100 new jobs at the Drogheda facility, plus a €62 million investment there, in December 2021. This investment aimed to upgrade site equipment and expand production of its PosiFlush syringes.

BD plans for the reduction to take place over 15 months to right-size manufacturing operations with “today’s realities.”

Given the length of time, BD expects natural attrition and retirements to reduce the number of employees actually affected. For those affected, the company said it remains committed to treat eac…

Brooke Story to become president of Surgery business at BD

Brooke Story

BD (NYSE: BD) + announced today that it named Brooke Story president of its Surgery business unit.

Story’s responsibilities include driving the strategic, operational and commercial performance of the business unit. She reports to Rick Byrd, EVP and president of the Interventional segment at BD. The move for Story, who currently serves as president of the Integrated Diagnostic Solutions (IDS) unit, goes into effect on July 3.

“Brooke has spent more than two decades in this industry with proven leadership capabilities that help address unmet needs in health care,” said Byrd. “She led IDS with a relentless focus on the core business and transformative solutions, supporting growth along the diagnostic continuum from specimen management to molecular diagnostics and informatics to microbiology.

“As president of our fast-growing Surgery business, she will be uniquely positioned to expand our i…

BD sells surgical instrumentation assets to Steris for $540M

BD (NYSE: BD) + announced today that it signed a definitive agreement to sell its surgical instrumentation platform to Steris (NYSE:STE) for $540 million.

The divestiture includes V. Mueller, Snowden-Pencer and Genesis branded products. BD reports its surgical instrumentation platform as part of its Surgery unit within its Interventional segment.

In the deal, Steris also gets three manufacturing facilities in St. Louis, Cleveland, and Tuttlingen, Germany. Approximately 360 employees across the unit are set to transfer to Steris upon completion of the transaction.

BD and Steris expect the divestiture to close within the former’s fiscal year, ending Sept. 30, 2023. It remains subject to customary closing conditions and U.S. Federal Trade Commission (FTC) approval.

The BD view

BD said this divestiture “advances the ‘Simplify’ pillar of the BD 2025 strategy.” It marks an importan…

Artificial intelligence: What medtech’s top influencers think

Artificial intelligence’s effect on medtech was a question that came up continually during our DeviceTalks Boston show in early May.

Here is what some of the top influencers in the industry had to say:

Boston Scientific CEO Mike Mahoney [Photo courtesy of Boston Scientific]

Boston Scientific CEO Mike Mahoney on artificial intelligence and medtech

“I’ll give you some practical applications. … We have manufacturing plants around the world, and we have great quality systems, and we have great quality engineers who inspect everything, and we have a zillion microscopes looking at every little product that we have all over the world. Our team is leveraging AI capabilities for visualization inspection rather than the human eye constantly doing that with the mistakes that are inherent and scrapping products and so forth. … We’re seeing cost productivity and better quality by just leveraging AI in our…

The top IVD innovation news stories of 2023 — so far

[Image courtesy of the National Cancer Institute via Unsplash]This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space.

According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using tiny sensors stuck under to skin to measure blood glucose — and much more.

Here are five IVD innovation stories that have caught our attention so far this year:

5. Hologic wins FDA clearance for COVID-flu-RSV assay

Last winter, the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. So it was welcome news in May when Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Read the full story a…

BD wants to increase education on sexually transmitted infections

[Image courtesy of BD]Earlier this year, BD (NYSE: BDX) + shared results from a survey of more than 1,000 U.S. women found significant discrepancies in education around sexually transmitted infections (STIs).

Of these women, over 18 years old, 77% identified as knowledgeable about vaginal infections, including yeast infections. However, only 60% said they felt knowledgeable about treatment options for these infections and STIs. The study also found that, among women who have seen a healthcare provider for routine gynecological care, they found the provider was lacking in education around these issues.

In total, 82% felt they could receive more education from providers about STIs, and treatment options for them, plus vaginal infections. Additionally, 79% found they stood to learn more from providers about testing for STIs and vaginal infections.

BD shared the results from the Harris Poll in an effort to demonstrate t…

BD continues to expand in Ireland

[Image courtesy of BD]BD (NYSE:BDX) announced that it opened a new facility in Ireland and committed a further investment within the country.

Last week, the company held a grand opening ceremony for a new $4.3 million (€4 million) R&D facility in Blackrock, Dublin. BD also announced an additional $32.1 million (€30 million) investment to expand its Enniscorthy, Wexford manufacturing facility.

According to a news release, the two investments should create more than 85 new jobs in Ireland.

BD plans for its new 10,600-square-foot, purpose-built R&D facility in Blackrock to house 35 high-tech workers. It complements the company’s existing Limerick R&D facility, which employs more than 300 people.

The Blackrock facility’s focus centers around the commercialization of BD’s first on-body injector device, the Evolve. It also serves as the regional base of operations for sales, technical service and corporate functional support t…

Design firm Delve makes first acquisition under new owner

Delve developed a prototype of the SC360 proton-beam therapy system for ProNova. [Photo courtesy of Delve]

Delve announced its acquisition of Boston-based digital innovation and design firm Altr this week.

Madison, Wisconsin–based Delve said Altr is its first acquisition under the ownership of private equity firm Trinity Hunt Partners, which purchased Delve in May 2021 and merged it with product design consultancy firm Bresslergroup.

“Almost two years ago to the day, we announced our intention to build a company that could be considered the world’s best end-to-end product innovation firm,” Delve President Andrew Weiman said in a news release yesterday. “With Altr, we take another giant step forward. Much more to come.”

The deal comes as medical device developers are increasingly integrating digital offerings into their devices. Delve said the Altr deal “strength…

They said it at DeviceTalks Boston 2023

Medical device industry leaders from Boston Scientific, Abbott, ZimVie, Medtronic, Stryker and more met at DeviceTalks Boston to share lessons learned and their perspectives on industry trends, device design and medtech innovation.

BD Chair, CEO and President Tom Polen (right) at DeviceTalks Boston with DeviceTalks Editorial Director Tom Salemi [Photo by Jeff Pinette for Medical Design & Outsourcing]

Bidding farewell to DeviceTalks Boston 2023, we look back at an exceptional two-day medical device conference teeming with insights from over 100 top industry leaders.

These experts unfolded many complexities of the medtech industry in more than 35 sessions, walking attendees from the medical device product development continuum through the latest medical innovations and strategies to tackle regulatory challenges, prototyping, manufacturing, product launches and more.

Between the high-profile keynote int…