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FDA clears iRhythm’s ZEUS system for Zio Watch

iRhythm Technologies (Nasdaq:IRTC) announced today that it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system.

ZEUS, produced in partnership with Google’s Verily, combines deep-learned algorithms with iRhythm’s trusted cardiac arrhythmia service, providing the AI algorithm and solution component for the Zio Watch sensor-based wearable for non-invasive, clinical-grade, long-term continuous monitoring for AFib.

According to a news release, Verily also received FDA 510(k) clearance for the Zio Watch (study watch with irregular pulse monitor).

San Francisco-based iRhythm said that ZEUS provides an integrated, prescription-based solution that addresses clinician workflows, care pathways and the patient experience, while the wrist-worn Zio Watch not only detects AFib but also characterizes the amount of AFib over time.

Zio Watch uses a continuous photoplethysmography (PPG), AI-based algorithm to detect AFib and …

Google Health hires FDA’s chief digital health officer

Bakul Patel in 2016, when he was the associate director for digital health in the FDA’s Center for Devices and Radiological Health [FDA photo by Michael Ermarth]Former FDA Chief Digital Health Officer of Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency.

Patel became senior director, global digital health strategy and regulatory for Google Health earlier this month, he said on LinkedIn.

Patel recounted highlights of his “incredible journey since 2008” at the FDA, including the introduction of functionality-based regulations in the FDA’s mobile medical apps guidance, working with international agencies to define and regulate software-as-a-medical-device (SaMD), developing the Digital Health Software Precertification (Pre-Cert) Program and launching the Digital Health Center of Excellence.

Patel had only been in his latest role at FDA since February, previously serving as director of the FDA…

Google Health hires FDA’s chief digital health officer

Bakul Patel in 2016, when he was the associate director for digital health in the FDA’s Center for Devices and Radiological Health [FDA photo by Michael Ermarth]

Former FDA Chief Digital Health Officer Global Strategy and Innovation Bakul Patel has started a new job with Google after 13 years with the regulatory agency.

Patel became senior director, global digital health strategy and regulatory for Google Health earlier this month, he said on LinkedIn.

Patel recounted highlights of his “incredible journey since 2008” at the FDA, including the introduction of functionality-based regulations in the FDA’s mobile medical apps guidance, working with international agencies to define and regulate software-as-a-medical-device (SaMD), developing the Digital Health Software Precertification (Pre-Cert) Program and launching the Digital Health Center of Excellence.

Patel had only been in his…

The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

[Illustration via Adobe Stock] Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare.

The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients.

Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD).

Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon (Nasdaq: AMZN), Microsoft (Nasdaq: MSFT) and Google (Nasdaq: GOOGL).…

The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

[Illustration via Adobe Stock]

Leaders in medtech and cloud computing discuss payoffs and potential in device connectivity, product development and cross-industry partnerships.

If knowledge is power, that power comes from a steady stream of information, and we know there’s no shortage of that in healthcare.

The challenge has long been how to capture that information, store it, analyze it and deploy it to improve medical product design, manufacturing and the health of patients.

Then came the cloud, and with it a host of acronyms: software as a service (SaaS), platform as a service (PaaS), infrastructure as a service (IaaS), and — following the same convention — software as a medical device (SaMD).

Over the past few months, Medical Design & Outsourcing connected with leaders in medtech and cloud computing, including the three largest providers of cloud computing services: Amazon (Nasda…

May 2022 Issue: The cloud is transforming medtech

The cloud is transforming medtech: Amazon, Microsoft, Google, J&J, Philips and GE Healthcare leaders explain

How DeepWell is developing video games as tools for treating medical conditions

Digital therapeutics open up new opportunities in medicine

Harnessing the power of cloud computing

When Johnson & Johnson and Microsoft announced a deal earlier this year to use cloud computing to support digital surgery, executives on both sides spoke with Medical Design & Outsourcing about how the partnership could advance medtech.

That started a series of conversations with leaders at cloud computing giants Google, Microsoft and Amazon — and on the device side at Johnson & Johnson, Philips and GE Healthcare. We consistently heard that the COVID-19 pandemic accelerated cloud adoption not only for medical records and telehealth, but also for manufacturing operations, supply chain management and making new vaccines, therapies and d…

Amazon Web Services is powering medtech innovation: Its chief medical officer explains

Dr. Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]

It doesn’t get any bigger than Amazon in the world of cloud computing.

The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.

Dr. Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.

In the following interview, Kass-Hout explains how Moderna was born in the cloud and how the company has used cloud computing to scale mRNA technology.

Get the full story from our sister site, Medical Design …

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…

Google unveils AI-powered Care Studio Conditions to make sense of patient records

Google Health’s new Care Studio feature, Conditions [Screenshot courtesy of Google]Google Health previewed a new Care Studio feature called Conditions to make electronic health records more accessible and useful for clinicians treating patients.

Powered by artificial intelligence, Conditions can interpret and organize clinical notes stored across different systems for different purposes by different health care professionals.

‘When it comes to writing notes, clinicians use different abbreviations or acronyms depending on their personal preference, what health system they’re a part of, their region and other factors.” Paul Muret VP and GM of Google Health’s Care Studio, wrote yesterday in a blog post. “All of this has made it difficult to synthesize clinical data — until now.”

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

Google unveils AI-powered Care Studio Conditions to make sense of patient records

Google Health’s new Care Studio feature, Conditions [Screenshot courtesy of Google]

Google Health previewed a new Care Studio feature called Conditions to make electronic health records more accessible and useful for clinicians treating patients.

Powered by artificial intelligence, Conditions can interpret and organize clinical notes stored across different systems for different purposes by different health care professionals.

‘When it comes to writing notes, clinicians use different abbreviations or acronyms depending on their personal preference, what health system they’re a part of, their region and other factors.” Paul Muret VP and GM of Google Health’s Care Studio, wrote yesterday in a blog post. “All of this has made it difficult to synthesize clinical data — until now.”

Conditions uses natural language processing to understand the notes, rank conditions b…

Designing a life-saving device on the cloud

Delta Development’s Autonomous Portable Refrigeration Unit, or APRU [Photo courtesy of Delta Development]

In its quest to build a better blood and vaccine cooler, Delta Development designed its Autonomous Portable Refrigeration Unit (APRU) over the cloud.

Instead of ice-packed coolers like the kind you might take on a camping trip, Tucson, Arizona-based Delta Development’s APRU refrigerates fresh whole blood and vaccines with a built-in battery that lasts for days on a single charge. The APRU also constantly monitors the temperature and can withstand outdoor elements such as water and ice, dust, UV rays and extreme temperatures.

Delta Development Chief Technology Officer Robert Futch [Photo courtesy of Delta Development]

As part of the Medical Design & Outsourcing cloud conversation series with medtech innovators and leaders, Delta…

How the cloud tools behind Google Maps and Photos can advance medtech

Alissa Hsu Lynch is Google Cloud’s global lead for medtech strategy and solutions. [Photo courtesy of Google]Alissa Hsu Lynch leads medtech strategy and solutions at Google Cloud, previously serving in executive roles at Johnson & Johnson and Bausch Health.

As part of Medical Design & Outsourcing‘s ongoing series of conversations about the cloud’s contributions to the medical device industry and its future, Lynch offered her perspective from the Alphabet (NASDAQ:GOOGL) subsidiary’s cloud-computing business. The following exchange has been edited for clarity and length.

Get the full story at Medical Design & Outsourcing.