FDA and VA Ventures Innovation Institute partner on new medical device testing tools

Dr. Beth Ripley is the medical device testing collaboration’s project manager for the VA. [Photo courtesy of the Department of Veterans Affairs]

The Department of Veterans Affairs’ VA Ventures Innovation Institute in Seattle will host up to a dozen FDA staffers in a new collaboration to develop and share new tools for medical device testing safety and efficacy.

The agencies intend to provide developers of devices and new technology with off-the-shelf tools that can help streamline regulatory review and get products to patients faster. FDA staff from the Center for Devices and Radiological Health (CDRH) will focus on regulatory science. Their partners at the VA’s Veterans Health Administration (VHA) will provide clinical context for test development and provide hands-on training and other immersive experiences for innovators wishing to utilize the tools.

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Researchers develop at-home device to track Parkinson’s progression

An at-home monitoring system could help monitor Parkinson’s progression and response to medication. [Image by N.Fuller/SayoStudio]

Researchers at MIT and the University of Rochester Medical Center have developed a device to monitor a Parkinson’s patient at home.

Collecting data at home could help provide a less subjective measurement than evaluations at the doctor’s office, which can be affected by outside factors. The technology could also help pharmaceutical and biotech companies developing new therapies for Parkinson’s, which is the world’s fastest-growing neurological disease.

In a one-year study with 50 patients, machine learning algorithms analyzed the data to help clinicians track Parkinson’s progression and medication response more effectively than periodic evaluations in a medical facility, MIT said in a news release. The study fund that gait speed declined ne…

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Mayo Clinic develops AI childbirth risk prediction tool for women in labor

Dr. Abimbola Famuyide is a Mayo Clinic OB-GYN studying AI algorithms for childbirth. [Photo courtesy of Mayo Clinic]

Mayo Clinic researchers are using AI algorithms to calculate childbirth risk while women are in labor in an effort to reduce the rate of cesarean delivery and complications.

The machine learning algorithms — a type of device known as Software as a Medical Device (SaMD), where the software is the device rather than a mechanical device — analyze patterns of changes for women in labor.

ADVICE: How to pass the patent eligibility test for Software as a Medical Device

“This is the first step to using algorithms in providing powerful guidance to physicians and midwives as they make critical decisions during the labor process,” senior author Dr. Abimbola Famuyide said in a news release. “Once validated with further research, we believe the algorithm will work in real time,…

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Johnson & Johnson leaders discuss what’s possible with the Microsoft cloud deal

Johnson & Johnson Group CIO and Global Vice President of Medical Devices Larry Jones [Photo courtesy of J&J]

Two leaders from Johnson & Johnson connected with Medical Design & Outsourcing this week to discuss the medical device maker’s partnership with Microsoft, the cloud’s potential for medical devices and to offer advice for medtech engineers designing for connectivity.

In January, New Brunswick, New Jersey–based Johnson & Johnson (NYSE:JNJ) named Redmond, Washington-based Microsoft (NASDAQ:MSFT) as its preferred cloud provider for digital surgery solutions and partner on building out J&J’s digital surgery platform and internet of things (IoT) device connectivity.

Johnson & Johnson Group CIO and Global Vice President of Medical Devices Larry Jones and Office of Digital Innovation Leader Peter Schulam (who also serves as global head of medical affairs, clinical a…

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FDA debuts plan for AI-based Software as a Medical Device

(Image courtesy of the FDA)

The FDA today released its first plan to regulate artificial intelligence/machine learning (AI/ML)-based Software as a Medical Device (SaMD).

The plan is a response to feedback received from the agency’s April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.”

Get the full story on our sister site, Medical Design & Outsourcing.

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