BD, Mayo Clinic team up to improve patient care

BD (NYSE:BDX) announced today that it will collaborate with Mayo Clinic Platform to perform detailed post-market surveillance.

Franklin Lakes, New Jersey-based BD’s collaboration with Mayo Clinic Platform will access de-identified patient data from the Mayo Clinic Platform_Discover to perform post-market surveillance on the company’s products and fuel innovation, unlocking a faster, more efficient path to market with the overarching goal of improving patient care.

According to a news release, Mayo Clinic Platform_Discover represents a robust de-identified data set available from 10 million patients, including both structured and unstructured data, images, 1.2 billion lab test results, 3 million echocardiograms and more than 640 million clinical notes.

BD intends to use the platform’s capabilities in data mining, next-generation artificial intelligence (AI) and machine learning tools to analyze real-world data to generate insight into th…

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Anumana wins FDA breakthrough nod for AI algorithm that detects pulmonary hypertension

Anumana announced today that it received FDA breakthrough device designation for its pulmonary hypertension (PH) early detection algorithm.

Cambridge, Massachusetts-based Anumana, formed by Mayo Clinic and nference and launched in 2021, designed its AI-enhanced, electrocardiograph (ECG)-based PH early detection algorithm as a precise, non-invasive screening tool to provide earlier diagnosis for patients with PH that may otherwise go unnoticed until the disease has advanced.

The algorithm leverages 12-lead ECGs and is enabled by the nference platform that provides insight from more than 6 million de-identified patient records, including over 8 million ECGs. It analyzes the voltage-time data and within seconds provides a prediction of the likelihood of PH, reducing the time between initial symptoms and the first evaluation for PH via targeted cardiac imaging.

According to a news release, the algorithm was developed through a collaboration between data scie…

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gBETA Medtech accelerator picks its next startups

The gBETA Medtech virtual accelerator today named the five startups that will participate in the spring program leading up to the June 21 showcase day.

“We’re so fortunate to have such a diverse set of founders with expertise across the healthcare continuum,” gBETA Medtech Director KC Caine said in a news release. “Our founders are bringing high-impact innovations to the sector, and we’re excited to see how their companies grow.”

gBETA is a program of startup accelerator Gener8tor and the University Enterprise Labs business incubator in St. Paul, Minnesota, with mentorship support from Mayo Clinic, the University of Minnesota and Medical Alley Association. The program’s founding sponsor is Boston Scientific; UEL and Gener8tor also get support through a cooperative agreement with BARDA DRIVe.

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Mayo Clinic’s new Apple Watch app uses AI to detect left-ventricular dysfunction

The Mayo Clinic developed a new app that transmits ECG signals from Apple Watches for AI analysis to identify heart disease.

The application transmits ECG (electrocardiograms) signals recorded in non-clinical environments seamlessly and securely to a medical center so that the AI analysis can identify left-ventricular dysfunction, a life-threatening, asymptomatic heart disease.

According to a news release, a study — for which results were presented as late-breaking clinical science during Heart Rhythm 2022 — observed 2,454 subjects from 46 states and 11 countries who downloaded the study app for their Apple Watch. The average age was 53±15 years and 56% were female.

Mayo Clinic’s app sent all previously recorded ECGs for clinician review and AI analyzed ECGs acquired within one month of a clinically ordered ECG. They were evaluated for the presence of ejection fraction ≤40% using a model adapted for single lead use.

“We have seen how artific…

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This CEO is swallowing his own devices to fund his swimming PillBot

Endiatx co-founder and CEO Torrey Smith with PillBot in his Oakland, California, workshop [Photo by Hardy Wilson for MDO]As he prepared to swallow his robot for the first time, Torrey Smith’s doctors warned that the battery was his greatest threat.

If the capsule came apart and the battery burned the tissue lining his stomach, it would only be the beginning of a very bad experience.

“I was just hoping that we would get any kind of a positive signal that we were on the right track,” Smith, co-founder and CEO of Endiatx, said of the June 2020 test. “At that time, our radio bandwidth was so limited. We were pushing 48 pixels square of grayscale, not even color, at just a few frames per second. The worst video quality you could imagine — but it was real.”

The PillBot prototype’s inaugural journey into Smith’s gastrointestinal tract was a success, beaming live footage from his stomach without anesthesia, sedation, recovery time or air pumped into his gut to infl…

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Deadline nears for gBETA Medtech startup accelerator

The gBETA program for medtech startups is seeking applicants from across the globe on or before March 14 for its spring session.

The seven-week gBETA Medtech virtual accelerator runs April 18 through June 14. gBETA is a program of startup accelerator Gener8tor and the University Enterprise Labs business incubator in St. Paul, Minnesota, with support from Mayo Clinic, the University of Minnesota, Medical Alley Association and founding sponsor Boston Scientific.

Up to five startups will be selected for the medtech program, which covers medical devices, diagnostics, healthcare software, biotechnology, drug discovery and delivery and more.

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Mayo Clinic helps launch two new companies for improved diagnostics

Mayo Clinic announced that it is introducing a new technology platform to support two new companies it has launched.

Rochester, Minn.–based Mayo Clinic’s Remote Diagnostics & Management Platform (RDMP) is designed to connect data with new AI algorithms and augment human decision-making within existing clinical workflows, according to a news release.

“The dramatically increased use of remote patient telemetry devices coupled with the rapidly accelerating development of AI and machine learning algorithms has the potential to revolutionize diagnostic medicine,” Mayo Clinic Platform president Dr. John Halamka said in the release. “With RDMP, clinicians will have access to best-in-class algorithms and care protocols and will be able to serve more patients effectively in remote care settings. The platform will also enable patients to take more control of their health and make better decisions based on insights delivered directly to them.”

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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…

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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…

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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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