Abbott imaging catheter recall flagged as Class I by FDA

Abbott’s Dragonfly OpStar Imaging Catheter [Photo courtesy of Abbott]The FDA has identified the Abbott (NYSE:ABT) recall of its Dragonfly OpStar Imaging Catheter as a Class I recall.

That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11.

The recall affects 4,800 devices in the U.S. from certain lots. Abbott is asking health care providers to stop using the devices.

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Will Johnson & Johnson buy Boston Scientific?

Needham & Co. analyst Mike Matson today upgraded his rating of Boston Scientific (NYSE:BSX) shares to Buy, partly because he thinks it’s an acquisition target for Johnson & Johnson (NYSE:JNJ).

Said Matson: “If JNJ decides to acquire a large medtech company, we believe that BSX could be a good fit.”

BSX shares were up more than 2% to $41.19 apiece by midday trading today, while JNJ shares were down slightly. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up slightly.

Boston Scientific spokesperson Kate Haranis said the company doesn’t comment on speculation and rumors. A J&J spokesperson couldn’t immediately be reached for comment.

Johnson & Johnson remains on track to spin off its consumer health business in 2023, fueling conjecture that it may want to buy a medical device company to make the size of its MedTech business more on par in revenue…

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Needham & Co. downgrades Medtronic, Zimmer Biomet shares

[Image from Unsplash]Needham & Co. senior research analyst Mike Matson today downgraded his rating of Medtronic (NYSE: MDT) and Zimmer Biomet (NYSE: ZBH) shares to Hold, while Boston Scientific (NYSE:BSX) got an upgrade to Buy.

MDT shares were down more than 1% to $97.98 apiece in morning trading, a day after Q4 earnings that missed The Street sent the medtech giant’s stock down more than 5%. ZBH shares were down slightly at $119.87 apiece, while BSX shares were up more than 2% at $41.15 apiece. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 1%.

When it came to Medtronic, Matson said: “The more things change, the more they stay the same.”

“MDT seems to have returned to its old pattern of poor execution and inconsistent results, and this is its third strike in our view, with the first being pipeline challenges (RDN and robotics) and the second bei…

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DoMore Diagnostics wins CE mark for AI algorithm that predicts colorectal cancer outcomes

DoMore Diagnostics announced that it received CE mark approval in Europe for its Histotype Px Colorectal deep learning algorithm.

Oslo, Norway-based DoMore designed its Histotype Px Colorectal deep learning algorithm to predict colorectal cancer patient outcomes based on analysis of digital histology images.

The company said in a news release that the algorithm, which builds on research led by the Institute for Cancer Genetics and Informatics at Oslo University Hospital, represents the first CE-marked product to utilize artificial intelligence (AI) to predict patient outcomes based on advanced image analysis.

Analysis with the Histotype Px Colorectal deep learning algorithm is conducted on high-resolution scans from standard H&E stained slides to provide shorter turnaround times, DoMore Diagnostics said.

Results from an early version of the algorithm were published in The Lancet, while the company has spent the last year applying improvements …

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Quidel, Ortho Clinical Diagnostics combine to form in vitro diagnostics company

Quidel (Nasdaq:QDEL) announced today that it completed its $6 billion acquisition of Ortho Clinical Diagnostics (Nasdaq:OCDX).

In December 2021, San Diego-based Quidel and Ortho Clinical Diagnostics came to an agreement under which the former would acquire the latter for $24.68 per share of common stock, using a combination of cash and newly issued shares in the combined company, representing a 25% premium on Ortho’s closing price on Dec. 22, 2021, and an equity value of about $6 billion.

Under the terms, former Ortho shareholders received $7.14 in cash and 0.1055 shares of QuidelOrtho common stock for each Ortho common share. Former Quidel stockholders received one share of QuidelOrtho common stock for each share of Quidel common stock, according to a news release.

Under the terms of the agreement governing the transaction, former Ortho shareholders received $7.14 in cash and 0.1055 shares of QuidelOrtho common stock for each Ortho common share. Former …

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Zimmer Biomet adds ESG and CEO visibility to executive’s duties

Zimmer Biomet Chief Communications and Administration Officer Keri Mattox [Photo courtesy of Zimmer Biomet]Zimmer Biomet (NYSE:ZBH) today announced additional responsibilities for Investor Relations SVP and Chief Communications Officer Keri Mattox.

Mattox’s new title at the Warsaw, Indiana-based orthopedics company is chief communications and administration officer.

She will be responsible for “building and executing a comprehensive strategy around Environmental, Social and Governance (ESG) initiatives and increasing CEO visibility, engagement and accessibility,” the company said in a news release.

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U of Maryland scientist to set up NIH’s new Advanced Research Projects Agency for Health

U.S. Department of Health and Human Services (HHS)

U.S. Dept. of Health and Human Services (HHS) announced that it formed a new research project agency for health.

HHS Secretary Xavier Becerra announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health (NIH). Adam H. Russell was appointed as acting deputy director, effective next month.

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‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems

Medtronic CEO Geoff Martha [Photo courtesy of Medtronic]Medtronic CEO Geoff Martha today said a “catastrophic explosion” in Medtronic’s supply chain for packaging and a shortage of resins were the biggest issues hurting the company’s fourth-quarter performance.

Fridley, Minnesota-based Medtronic (NYSE:MDT) reported about $350 million less in sales than analysts were expecting for the quarter, which ended April 29.

Martha said about 75% of the miss was caused by supply chain issues, 15% by the COVID-19 lockdown in China and the last 10% due to foreign exchange rates getting worse.

Supply chain struggles “came out fast and hard” in the fourth quarter across the company’s businesses, but were most pronounced in Surgical Innovations (SI), Martha said.

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FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon.

Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent.

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Medtronic ‘hopeful’ on FDA clearance for next-gen diabetes tech in FY 2023

The Medtronic MiniMed 780G system. [Image from Medtronic]The Medtronic (NYSE:MDT) diabetes business sputtered in the fourth quarter but could be bolstered by a major regulatory nod this year.

The Fridley, Minnesota-based company saw revenues for its diabetes arm fall by 7.7% year-over-year in the fourth quarter amid overall misses on both sales and adjusted earnings per share compared to Wall Street’s expectations.

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Bigfoot Biomedical adds former Insulet VP as chief commercial officer

Bigfoot Biomedical’s smart insulin pen cap [Image from Bigfoot Biomedical]Bigfoot Biomedical announced today that it appointed former Insulet executive Matt Rainville as its chief commercial officer.

Rainville’s role includes leading the growth of Milpitas, California-based Bigfoot Biomedical’s fully commercial Bigfoot Unity diabetes management program as the company looks to expand access to its offerings.

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Medtronic, DaVita to form new kidney care company

Medtronic (NYSE:MDT) and DaVita (NYSE:DVA) today announced the intent to form a new medical device company for kidney care.

The new, independent company — dubbed “NewCo” — aims to enhance the patient treatment experience and improve overall outcomes for kidney care patients.

According to a news release, the new company will bring together Medtronic’s capabilities as a healthcare technology leader and DaVita’s expertise as a comprehensive kidney care provider. NewCo will focus on developing a wide range of novel kidney care products and solutions, including future home-based products to make different dialysis treatments more accessible.

“This is an exciting moment that will shape the future of kidney care,” Ven Manda, president of Medtronic’s renal care solutions business and NewCo’s CEO upon close, said in the release. “Our singular focus on end-to-end kidney health solutions will position this new c…

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