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Top stories summarized by our editors
1/26/2022

Fresh off the news that a heart from a genetically modified pig was successfully transplanted into a man, the American Journal of Transplantation published a study by researchers at the University of Alabama at Birmingham documenting the first successful transplant of kidneys from a genetically modified pig into a brain-dead person on life support whose own kidneys were donated. Just days earlier, surgeons at NYU Langone Health had kept a kidney from a genetically altered pig functioning in a patient's thigh for 54 hours, and taken together, the xenotransplantations hold "tremendous potential" for the hundreds of thousands of people on organ donation waiting lists, says Dr. David Klassen, chief medical officer at the United Network for Organ Sharing.

1/26/2022

Extracellular vesicles that express ACE2 isolated from plasma or cells of COVID-19 patients act as decoys and neutralize SARS-CoV-2 infection, according to a study in Nature Communications. Researchers developed a nanoparticle vaccine based on on evACE2 that protected mice from infection when administered nasally.

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FierceBiotech
1/26/2022

With lots of love, care and patience from Annette and Noé Tirado-Muñiz, Arrow overcame past trauma and grew into a confident and happy dog. Routine veterinary care and vaccinations made possible by animal research and testing helped Arrow have a healthy life. Read's more of Arrow's story by Dr. Noé and Annette Tirado-Muñiz on FBR's website.

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fbresearch.org
1/26/2022

The FDA on Tuesday released final guidance outlining best practices for incorporating patient-reported outcome instruments in medical device clinical trials. Separately, another final guidance, released the same day, explains how developers can enhance the design and conduct of medical device clinical studies by incorporating patient input.

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Regulatory Focus
1/26/2022

The FDA has approved Medtronic's Intellis rechargeable neurostimulator and Vanta recharge-free neurostimulator to treat chronic pain associated with diabetic peripheral neuropathy. "This new indication enables us to apply Medtronic's more than 40 years of proven [spinal cord stimulation] experience, as well as the company's deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients," said Charlie Covert, vice president and general manager of pain therapies within Medtronic's neuromodulation business.

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Becker's Spine Review
1/26/2022

The FDA has given breakthrough device designation to Pathogenomix for its Patho-Seq assay, a fast bacteria test that is able to detect conditions like bacterial meningitis and sepsis from different sample types.

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FDAnews
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sepsis
1/26/2022

BioFire Defense has received 510(k) clearance from the FDA for its COVID-19 Test 2. The test, which was designed to be used with the company's FilmArray device, detect SARS-CoV-2 within 45 minutes.

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FDAnews
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SARS
1/26/2022

3M generated $8.61 billion in sales and $1.1 billion in profits during its fourth quarter, which ended Dec. 31. "As we continue to actively manage our portfolio and improve our operations, we will prioritize investments in fast-growing end markets to drive long-term growth, as well as advance our commitment to sustainability," said CEO and Chairman Mike Roman.

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MassDevice (Boston)
1/26/2022

Johnson & Johnson generated $24.8 billion in sales and $4.7 billion in profits during its fourth quarter, which ended Dec. 31. "Given our strong results, financial profile, and innovative pipeline we are well-positioned for success in 2022 and beyond," said CEO Joaquin Duato.

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MassDevice (Boston)
1/26/2022

Carl Vause, former global franchise leader at Smith & Nephew, has been tapped to serve as CEO and president of Hyalex Orthopedics. The company has also chosen Michael Hawkins to serve as chief technical officer and he will continue to be the director of the company's board.

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Becker's Spine Review
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Smith & Nephew, Michael Hawkins