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MedAccred joins The Irradiation Panel

NEWS RELEASE: MedAccred Program Joins Influential Irradiation Industry Association

MedAccred Sterilization Staff Engineer and Auditor Kim Patton [Photo courtesy of MedAccred]

The MedAccred program has become a member of The Irradiation Panel, a renowned not-for-profit industry association representing global and diverse interests in radiation processing.

The panel is comprised of suppliers and users of irradiated products and irradiation services, regulatory bodies, and consultants. Membership currently consists of 46 companies and nine individual members, including Steris, Sterigenics, BD, Smith & Nephew, NPL, Nelson, IBA, Mevex, and Astra Zeneca.

Established in 1966 and based in the UK, it has members from across Europe and beyond, and provides a forum for discussing the advancement, development, promotion, regulation and practice of radiation processing using electron beam, gamma, and X-ray techno…

BD expands availability of all-in-one flush pre-filled syringe

The PosiFlush SafeScrub syringe. [Image courtesy of BD]BD (NYSE:BDX) announced today that it expanded customer availability for its all-in-one pre-filled flush syringe.

Franklin Lakes, New Jersey-based BD designed its PosiFlush SafeScrub syringe with an integrated disinfection unit. It reinforces compliance to infection prevention guidelines, simplifying nursing workflow.

BD built the active disinfection unit right into the tip cap of the PosiFlush SafeScrub syringe. It demonstrated via in vitro testing a significant reduction in microbial growth associated with catheter-related bloodstream infections (CRBSIs).

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

FDA clears AI software for MRSA diagnostics from BD

The BD Kiestra MRSA imaging app powered by AI. [Image courtesy of BD]BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its new Kiestra imaging application that uses AI.

The Kiestra methicillin-resistant staphylococcus aureus (MRSA) imaging application uses AI to interpret bacterial growth and release negative specimens with minimal human interaction.

Franklin Lakes, New Jersey-based BD designed the Kiestra MRSA application to utilize AI to automate this inspection process. These traditionally require labor- and time-intensive inspections of Petri dishes to determine if bacterial growth occurred. With Kiestra’s automation capabilities, scientists and technicians can spend more time on higher-value analysis.

BD said in a news release that the application can evaluate single specimens or group together large volumes. That could help reduce the administrative burden on technicians, the company added.

The MRSA imaging applicati…

BD explores plastic blood tube recycling

Blood tube recycling could give new life to high-quality materials that are currently incinerated after use. [Photo via Adobe Stock]

Becton, Dickinson and Co. (NYSE:BDX) will explore blood tube recycling in a sustainability pilot program.

BD’s partners include Odense University Hospital, the Health Innovation Centre of Southern Denmark, Danish Technological Institute, and GMAF Circular Medico/EcoFitt.

These plastic blood collection tubes are made from high-quality raw materials, but are incinerated with other biohazardous waste after use. The blood tube recycling pilot program will investigate the steps for recycling the tubes, including an evaluation of the recycled plastic’s quality and safety and hygiene precautions.

BD is the world’s largest manufacturer of evacuated blood collection tubes, BD Sustainable Medical Technology Institute Amit Limaye said.

“As part of…

BD CEO Tom Polen discusses crises-revealing character during COVID-19 pandemic

BD CEO, President and Chair Tom Polen [Photo courtesy of BD]Tom Polen’s original “master plan” included going to medical school. While preparing for the MCAT out of undergrad, he instead joined a small startup based in California.

Ultimately, the startup grew and BD (NYSE:BDX) bought it. That was about 23 years ago. Polen is now chair, president and CEO of the medtech giant, having assumed the role in early 2020.

He noted that BD acquired nine companies in the last three years — much like his startup many years before.

“It’s a pleasure to be able to stand in front of those teams when we bring them in as part of our family and say, ‘I came to BD the same way that all of you came to BD,'” Polen says. “I remember exactly the way that that first day felt.”

Speaking in a keynote address at DeviceTalks Boston today, Polen outlined his career path and how he’s led BD for the past three years.

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BD reports strong Q2, raises back end of 2023 guidance

BD (NYSE: BDX) + shares dipped today despite second-quarter financial results that came in ahead of the consensus forecast.

Shares of BDX slid 3.3% at $255 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 Franklin Lakes, New Jersey–based company posted profits of $460 billion in the quarter. That translates to $1.54 per share on sales of $4.8 billion for the three months ended March 31, 2023.

BD recorded a 1.3% bottom-line gain on 1.5% sales growth in the quarter. The company’s medical segment reported 9.6% growth and its interventional business grew by 6.8%. Life sciences revenue offset that growth slightly, dropping by 14.2%. That segment’s performance reflects a decline in COVID-only diagnostic testing revenues.

Adjusted to exclude one-time items, earnings per share came i…

Is medtech the answer to healthcare challenges?

[Image from Unsplash]The aftermath of the COVID-19 pandemic has healthcare in the U.S. and elsewhere facing a host of challenges, but medtech could be part of the answer.

Join industry leaders at DeviceTalks Boston, May 10–11, 2023, to find out more about the opportunities. (Register here!)

Here are some of the topics to explore at the event:

Healthcare challenges: Worker shortages

Hospitals and other healthcare settings are facing shortages of physicians, nurses and other critical staff — but one of many healthcare challenges.

BD CEO, President and Chair Tom Polen [Photo courtesy of BD]Opportunity: In a keynote interview, Becton Dickinson CEO Tom Polen will lay out a plan for growth building off a sequence of acquisitions over the past two years that has the company loaded with tech — including digital and robotics tools. In a DeviceTalks Weekly interview, Polen saw automation of pharmacies and lab testing as a sizable growth opportunity for BD.

BD wins FDA clearance for high-throughput infectious vaginitis diagnostic

The BD COR system. [Image from BD]BD (NYSE:BDX) announced today that it received FDA 510(k) clearance for its Vaginal Panel diagnostic on the COR system.

The comprehensive diagnostic test directly detects the three most common infectious causes of vaginitis. It uses the BD COR, the company’s high-throughput molecular diagnostic platform for large laboratories.

Franklin Lakes, New Jersey-based BD originally received marketing authorization for the panel for its BD MAX system. It’s the first microbiome-based polymerase chain reaction (PCR) assay that uses a single swab and test to simultaneously detect organisms with the three common causes: bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and Trichomonas vaginalis (TV).

The panel reports a clear positive or negative result for each condition separately. Clearance marks the first authorization for a high-throughput version of the test, BD said in a news release.

How the BD diagnostics business is driving greater access to care

The BD Max system. [Image courtesy of BD] It’s been a busy time for BD, with recent approvals further driving the company’s diagnostics business forward.

Dave Hickey and BD (NYSE:BDX) have their sights on what they call “transformative forces.” These forces could change the delivery of healthcare going forward.

Hickey, EVP and president of the Life Sciences segment at BD, said these forces include smart connected care, migration to new care settings and improving chronic disease outcomes.

Digitization and automation, plus point-of-care and at-home testing, comprise these areas. That’s where BD’s focus lies.

“Our innovation strategy and our investment dollars are going into those areas,” Hickey told MassDevice.

Recent news along these lines includes the February FDA emergency use authorization (EUA) for BD’s COVID-19, flu and RSV combination diagnostic. Just weeks later, the company received app…

FDA approves BD HPV assay for use with Hologic ThinPrep Pap test

The Onclarity HPV assay. [Image courtesy of BD]BD (NYSE:BDX) announced today that it received FDA approval for its Onclarity HPV assay for use with the ThinPrep Pap test.

The ThinPrep Pap test, developed by Hologic (Nasaq:HOLX), offers Pap and HPV testing from one vial. It accompanies the BD SurePath liquid-based Pap test vial as the most commonly used vials by labs in the U.S.

BD said in a news release that including ThinPrep in its testing offerings improves access to the benefits of its human papillomavirus virus (HPV) assay. That assay has approval for an extended set of HPV types. This includes HPV31, which poses a high risk for causing cervical cancer. In total, it detects and identifies 14 high-risk HPV types in a single analysis.

“Most tests report multiple HPV types in a single pooled result, which can mask the true risk of developing cervical cancer,” said Brooke Story, worldwide president of integrated diagnostics solutions for BD. &#…

BD issues vulnerability warning for Alaris infusion monitoring software

BD’s Alaris infusion pump and vital signs monitoring system is designed to deliver controlled amounts of fluid, medication, blood and blood products. [Photo courtesy of BD]BD (NYSE:BDX) today issued a voluntary notification regarding cybersecurity vulnerabilities with its Alaris Infusion Central software.

Alaris Infusion Central, a standalone software — separate from pumps — provides data from the Alaris pumps. It allows healthcare providers to monitor infusion data sent from Alaris Plus and Alaris neXus pumps on a computer. Alaris Infusion Central is not sold in the U.S. Despite similar product family names, the vulnerability does not impact users of the Alaris PCU 8015 or Alaris Systems Manager.

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

New medtech to watch for in 2023: boosting health outcomes

[Image from Pixabay]As earnings season is upon us, we’re receiving a clearer view of what new medtech could be launching this year in the medical device space.

Companies still feel hamstrung by macroeconomic pressures, supply chain issues and more. However, many pointed out that 2023 has plenty to look forward to. Several quarterly reports and earnings calls included positive outlooks for the year ahead, with plenty of companies banking on significant revenue growth and other successes.

For many, that comes down to some new medtech product launches. Here are a few picked out from earnings calls and other announcements that you might want to look out for:

Abbott

On Abbott’s earnings call last month, CEO Robert Ford pointed to product launches as a major part of its outlook for 2023.

Abbott said it expects to log adjusted EPS of between $4.30 and $4.50. Excluding COVID-19-related sales, the company expects high-single-digit revenue growth.<…