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Thermo Fisher Scientific, Mayo Clinic partner on new tools

Thermo Fisher Scientific and Mayo Clinic today announced a new collaboration that will take place near the respected health provider’s main Rochester, Minn. campus.

The partnership will focus on accelerating clinical validation and commercialization of certain next-generation sequencing (NGS), mass spectrometry and immunology diagnostic tools. Work will occur at the Advanced Diagnostics Laboratory at the 90,000-square-foot One Discovery Square that opened off Mayo Clinic’s Rochester campus in 2019.

“By pairing cutting-edge, innovative technologies with world-class clinical and diagnostic testing knowledge, this collaboration will ensure that the promising innovations are both clinically relevant and accessible globally,” said Dr. William Morice II, chair of Mayo Clinic’s Department of Laboratory Medicine and Pathology and president of Mayo Clinic Laboratories.

The Mayo Clinic and…

Companies, docs alarmed by proposed 510(k) rollback

Medical associations and device companies have largely come out against a Trump administration proposal to permanently exempt certain medical devices and software from the FDA 510(k) clearance process.

HHS used Trump’s waning days in office to propose permanently exempting 83 Class II devices and one unclassified device from the clearance review process. The list includes home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns. The agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance. The notice was published on Jan. 15, 2021, in the Federal Register.

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Google opening office near Mayo Clinic

Google announced today that it will open an office in downtown Rochester, Minn., to be close to Mayo Clinic.

The tech giant plans to have an office up and running with a handful of workers as soon as possible, given the ongoing COVID-19 pandemic, according to a news release posted on the website of the 20-year Destination Medical Center project. Under the DMC, $585 million in state and local government infrastructure funds are expected to leverage about $5 billion of private investment in Rochester, which is about an hour and a half drive south of Minneapolis.

Google will occupy space at Collider Coworking in the historic Conley-Maass-Downs building in downtown Rochester. The news comes nearly a year and a half after Google and Mayo Clinic announced a 10-year partnership to use advanced cloud computing, data analytics, machine learning and artificial intelligence (AI) to improve healthcare delivery.

“The COVID-19 pandemic has illustrated the importance o…

BioSig, Mayo Clinic announce AI development partnership

The Pure EP system [Image courtesy of BioSig Technologies]BioSig Technologies (NSDQ:BSGM) will work with the Mayo Foundation for Medical Education and Research to develop next-gen, AI-powered software for its Pure EP system, which is meant to take electrophysiology to the next level.

The Mayo Clinic has already been an important investor and development partner for the Westport, Conn.–based company. BioSig signed a 10-year collaboration agreement with Mayo Clinic in March 2017, signing three new patent and know-how license agreements with the Mayo foundation in November 2019.

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Hahn apologizes for convalescent plasma claim

FDA commissioner Stephen Hahn

Under intense criticism for his statement that convalescent plasma donated by former coronavirus patients could reduce COVID-19 deaths by 35%, FDA commissioner Stephen Hahn apologized on Twitter late Monday.

The agency announced on Sunday that it had granted an emergency use authorization (EUA) for plasma donated by coronavirus survivors as a treatment for new patients. President Trump, Hahn and U.S. Health and Human Services secretary Alex Azar all touted the 35% figure based on a small subgroup of hospitalized COVID-19 participants in a Mayo Clinic study — patients who were younger than 80 years old, not on ventilators and who received plasma that contained high levels of antibodies within 3 days of diagnosis, according to a report by the New York Times.

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Feds’ convalescent plasma claim questioned

[Coronavirus image courtesy of World Health Organization]

Scientists are questioning the Trump administration’s claim for the effectiveness of convalescent plasma in preventing deaths from COVID-19, according to published reports.

President Trump and the heads of the FDA and the Department of Health and Human Services all said on Sunday that plasma donated by former coronavirus patients has reduced deaths by 35%. Their calculation appears to be based on a small subgroup of hospitalized COVID-19 participants in a Mayo Clinic study — patients who were younger than 80 years old, not on ventilators and who received plasma that contained high levels of antibodies within 3 days of diagnosis, according to a report by the New York Times.

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Know Labs signs research agreement with Mayo Clinic

Know Labs today said it entered a research agreement with the Mayo Clinic to test and validate its Bio-RFID as a continuous glucose monitor.

Know Labs’ Bio-RFID technology is designed to be integrated in a number of wearable, mobile or bench-top form factors.

“We are very pleased to work with Mayo Clinic. They bring a world-renowned reputation in diagnostics. We look forward to working with them during this research project as we continue the development of our non-invasive UBand CGM,” Know Labs CEO Phil Bosua said in a news release.

Know Labs plans to launch its Bio-RFID within its wearable UBand as a non-invasive continuous glucose monitor.

Mayo Clinic performs first shoulder arthroplasty with Wright Medical mixed reality tech

Blueprint mixed reality technology [Image courtesy of Wright Medical]

Wright Medical (NSDQ:WMGI) today announced the first shoulder arthroplasty procedure performed using its Blueprint mixed reality technology.

Dr. Joaquin Sanchez-Sotelo performed the procedure at Mayo Clinic’s Rochester, Minn. campus, with the Blueprint software providing a 3-D holographic view of the pre-operative plan.

“This procedure is an important milestone for shoulder arthroplasty and marks a major step in the evolution of Blueprint mixed reality technology in shoulder surgery,” said Wright Medical CEO Robert Palmisano. “For the first time in shoulder arthroplasty, surgeons will be able to interact with their 3-D pre-op plan in real-time to more precisely tailor shoulder joint replacement procedures to the unique needs and anatomy of their patients.”

“By integrating other solutions in the futur…

What kinds of COVID-19 tests are out there?

(Image from Mayo Clinic)

Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it.

To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing landscape of tests for COVID-19 and the rapid rise of coronavirus cases in the parts of the country, we thought an overview of these tests might be helpful.

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Mayo Clinic needed to engineer its way through COVID-19: Here’s what they did.

The health system’s medical and engineering staffs had to devise their own solutions for lab gear, PPE and operating room air decontamination.

[Image courtesy of Mayo Clinic]

As COVID-19 settles into several regions of the U.S., healthcare systems that once sat on the sidelines likely will find themselves in the same situation as their counterparts in the Northeast did earlier this year.

While this may serve as little comfort, hospitals in regions getting hit by the new wave of the deadly virus do have the benefit of seeing how hospitals in the Upper Midwest and the Northeast managed the pandemic.

One of the easiest — or at least most evident — lessons available is the use of additive manufacturing or 3D printing. Mayo Clinic and other hospital systems, including Beth Israel Lahey in Boston, used their 3D printers to produce critical personal protective equipment (PPE) such as masks and face shield…

FDA approves Medtronic’s latest DBS

Medtronic’s Percept PC neurostimulator with BrainSense technology [Image courtesy of Medtronic]

Medtronic (NYSE:MDT) said today that it has received FDA approval for the Percept PC deep brain stimulation (DBS) system.

The medical device giant is touting Percept PC’s BrainSense technology, which is designed to sense and record brain signals while delivering DBS therapy to people with neurological disorders such as Parkinson’s disease.

BrainSense enables more personalized, data-driven neurostimulation treatment, according to Medtronic.

The FDA approval of the Percept PC neurostimulator means that health providers can use it to treat symptoms associated with Parkinson’s disease, essential tremor, primary dystonia, epilepsy and obsessive-compulsive disorder. The device gained the CE Mark in January.

Mayo Clinic in Rochester, Minn., will be th…

Mayo Clinic launches test to detect COVID-19 immunity

Mayo Clinic announced that it launched a new SARS-CoV-2 neutralizing antibody test in support of efforts to establish therapies and vaccines for COVID-19.

As part of the Expanded Access Program for Convalescent Plasma and other critical research efforts, Mayo Clinic intends to make the test available to select labs, blood banks and biopharma clients later this month.

Mayo Clinic designed the new test to measure the level of neutralizing antibodies against SARS-CoV-2, the virus causing COVID-19. The test provides semi-quantitative detection of total neutralizing antibodies in human serum. After infection, most will develop an immune response to COVID-19, including the production of neutralizing antibodies against the SARS-CoV-2 spike glycoprotein. However, it’s currently unknown for how long the neutralizing antibodies persist after infection.

The test should only be ordered upon confirmation of prior infection and it should not be used to diagnose …