SaMD development lessons from Cordio’s voice AI heart failure app

Cardio Medical HearO app analyzes the voice of heart failure patients to monitor their condition. [Photo courtesy of Cordio Medical]

Software as a medical device (SaMD) development requires a different approach than traditional medical devices in a few ways.

Repeat after me: My dad is a big chef.

Speaking that short sentence and a few others like it into a smartphone once a day helps identify deteriorating heart failure patients at risk of declining, Cordio Medical CEO Tamir Tal said.

Israel-based Cordio developed its software as a medical device (SaMD) product, the artificial intelligence (AI) voice app HearO, after a cardiologist noticed he could hear congestion in a declining patient’s voice. HearO compares a patient’s voice against baseline recordings to detect lung fluid build-up and alert their care team.

“The holy grail of the entire [heart failure] monitoring industry…

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Four gastroenterology device innovations doctors need now

Dr. Aasma Shaukat [Photo courtesy of NYU Langone Health]

Gastroenterology is a field ripe for medical device innovation, and medtech developers know that some of the best ideas come from practicing doctors.

With that in mind, Medical Design & Outsourcing spoke with two gastroenterologists to better understand what device innovations would help them better diagnose and treat gastrointestinal diseases.

Dr. Aasma Shaukat is the director of outcomes research at NYU Langone Health’s Division of Gastroenterology and Hepatology. She’s also the NYU Grossman School of Medicine’s Robert M. and Mary H. Glickman professor of medicine and a professor of population health.

Dr. Bara El Kurdi [Photo courtesy of Dr. Bara El Kurdi]

Dr. Bara El Kurdi is a gastroenterology fellow at University of Texas Health Science Center in San Antonio…
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Formlabs launches new skin-safe 3D printing material for healthcare

Formlabs’ TPU 90A Powder is a new skin-safe 3D printing material. [Image courtesy of Formlabs]

NEWS RELEASE: Formlabs Introduces TPU 90A Powder, The First Elastomer Material for Fuse Series 3D Printers

Formlabs, the leading 3D printing company, is excited to announce its newest material for Fuse Series printers: TPU 90A Powder, a tough elastomer powder. This new material enables strong, functional, skin-safe parts with high tear strength and elongation.

The strength and flexibility of TPU 90A powder allows for the production of fully functional parts in-house, providing complete design freedom and a seamless workflow on the Fuse Series SLS 3D printing ecosystem. By leveraging this material, engineers and manufacturers can bridge the gap between manufacturing stages, produce fully functional prototypes, manufacturing aids and end-use parts, and take full control of their supply chain. Additionally, TP…

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March 2023 Issue: Incredible enabling technologies

Stryker on steroids: How enabling technology will supercharge surgical robotics

How Penumbra’s smart-sucking algorithms and catheters speed up clot removal

What Abbott learned about COVID-19 and cardio devices

Genascence believes gene therapy can transform the treatment of knee osteoarthritis

What to expect in diabetes care in 2023

Incredible enabling technologies

The FDA has cleared or approved more than 500 devices enabled by artificial intelligence (AI) or machine learning, and the list keeps getting longer.

Medtech AI is helping physicians diagnose, treat and monitor patients like never before. Sometimes the software works as a medical device all on its own. But the real fun starts when device developers pair software with other enabling technologies like robotics, miniaturization, 3D printing and advanced materials.

For example, take Stryker…

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Qosina opens new ISO Class 8 cleanroom

Qosina’s 1700-square-foot ISO Class 8 cleanroom supports pick-and-pack expansion, increases capacity, and reduces lead times for customers.

NEWS RELEASE: Qosina Unveils New ISO Class 8 Cleanroom

Qosina, a global supplier of OEM single-use components to the medical and bioprocess industries, has completed the construction of its new state-of-the-art cleanroom. This 1700-square-foot, ISO Class 8 cleanroom supports the expansion of Qosina’s pick and pack process, allows the company to increase capacity, and reduce lead times for customers.

During the design and construction phases, Qosina worked diligently to develop novel shipping techniques for its medical and bioprocessing components. Qosina’s new cleanroom has ten workstations designated for its scale counting and repacking process.

“Our new cleanroom was built to accommodate the increased growth of our business, further showcasing our commitment to…

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Leveraging biophysics to fight the most aggressive forms of cancer

Novocure developed the Optune wearable device to deliver Tumor Treating Fields, electric fields that slow or stop cancer cells from dividing. [Photo courtesy of Novocure]

An innovative device harnesses the power of electric fields to disrupt solid tumor cell division.

By Bill Doyle, Novocure

For more than 20 years, Novocure has been at the forefront of innovation, pioneering biophysical cancer treatments. With the invention and development of Tumor Treating Fields therapy, Novocure is striving to extend survival in some of the most aggressive forms of cancer.

In modern medicine, cancer treatment has relied on combinations of surgery, ionizing radiation, and drugs — each of which can come with challenging side effects. In 2011, the FDA approved a first-of-its-kind medical device for recurrent glioblastoma that changed cancer therapy expectations with its novel mechanism of action for killing cancer ce…

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BCI company Science is getting into the outsourcing business

The Science Eye [Image from Science]

Brain-computer-interface (BCI) developer Science announced has launched a platform to enhance medical device manufacturing outsourcing.

Science CEO Max Hodak previously co-founded Neuralink, Elon Musk’s venture into brain-computer interfaces (BCIs). He served as president at Neuralink until 2021. His new venture with Science includes new BCI technology that doesn’t require an in-skull implant.

Last November, the company unveiled the Science Eye, a visual prosthesis. It targets retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD), two forms of serious blindness. The combination device uses an optogenetic gene therapy targeted at the cells of the optic nerve. It combines that with an implanted, flexible thin-film, ultradense microLED display panel inserted directly over the retina.

Science was among the top medical device venture capital dealm…

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Glowing nanoparticles enhance at-home COVID-19 test sensitivity

This glowing star inspired glow-in-the-dark COVID-19 testing technology developed by Richard Willson and his team at the University of Houston. [Image courtesy of the University of Houston)

Researchers at the University of Houston are using glow-in-the-dark materials to enhance the sensitivity of rapid COVID-19 home diagnostics.

The widely used lateral flow assay provides rapid results for diagnostics such as at-home COVID-19 or pregnancy tests. They also offer low costs and ease of operation. Test results on LFA diagnostics come through in colored lines.

“We are making those lines glow-in-the-dark so that they are more detectable, so the sensitivity of the test is better,” said Richard Willson, who’s leading the University of Houston team. 

Willson is the Huffington-Woestemeyer professor of chemical and biomolecular engineering at the UH Drug Discovery Institute and a professor of biochemic…

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Sunrise Labs announces engineering and quality promotions

NEWS RELEASE: Sunrise Labs Appoints New Leaders

Sunrise Labs, a medical device product development firm with offices in New Hampshire and Massachusetts, marked major milestones in 2022 by celebrating their 30th anniversary, expanding their office presence to the Boston area, and growing to over 100 employees.

In addition to the expansion and growth to better serve their clients, they are pleased to announce the following promotions:

Dave Hibbard, formerly Director of Programs has been promoted to VP of Engineering. In his new role, Dave will lead our engineering teams (Software, Electrical, Mechanical, and Systems) and work with the User-Centered Design team to deliver exceptional project outcomes to clients. A solution-focused leader, with deep experience in MedTech product development, Hibbard strives to provide unrivaled medical device services to ensure clients are highly satisfied.

Trisha Bouthot, formerly Director of Quality has been promoted to Se…

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Medical Design & Outsourcing wins 14 excellence awards from ASBPE

Medical Design & Outsourcing’s March and May 2022 editions

Medical Design & Outsourcing and seven members of our team are finalists for more than a dozen American Society of Business Publication Editors (ASBPE) Awards of Excellence.

ASBPE Awards of Excellence, also called Azbee Awards, recognize the highest quality reporting, editing and design in business-to-business, trade, association and professional publications.

MDO won five national and nine regional Azbee Awards. All finalists win awards of gold, silver, bronze or honorable mention. ASBPE will announce regional winners in April and national winners in May.

MDO’s national Azbee Awards

MDO‘s digital edition is a national finalist for overall excellence — the Azbee Awards’ highest level — in the category of digital magazine of the year.

Judges considered the March, May and July 2022 editions for this…

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How to run a pilot program to avoid a medtech nightmare

[Photo via Adobe Stock]

Limited launches are invaluable for gathering practical insights about a product before a full-scale launch.

By Haley Schwartz, Catalyze Healthcare

Scrambling to address product limitations, clinical implementation pitfalls and competitive edges during a full-scale product launch is a painfully headache-ridden process many have experienced.

Running a smooth pilot program is imperative to uncovering these issues, creating an engineering triage plan and ultimately reducing risk to the entire launch — though flawless execution is far from easy.

Let’s dive into the key steps to define and optimize your chances of success.

Set expectations for the pilot program

First, create a plan and establish an understanding that each participating member will have to sign off and comply with the pilot’s expectations as terms of participation. Socialize this idea internally to e…

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FDA clears first device authorized under Safer Technologies Program

The FDA last week cleared a new gastric calibration tube, marking the first authorization of a device under the agency’s Safer Technologies Program.

FDA launched its Safer Technologies Program in 2021. It modeled the program on its breakthrough devices program. The Safer Technologies Program (STeP) covers devices that could improve the safety of treatments or diagnostics. These are aimed at underlying diseases or conditions that are less serious than those eligible for the breakthrough program.

These devices should improve on existing diagnostics’ or treatments’ safety by reducing adverse events, device failures, use-related hazards or user errors or by improving the safety of other devices or interventions.

In a news release, the FDA said it intends for the program to offer patients more timely access. It does this by expediting product development, assessment and review. However, the FDA says it maintains its standards for safety and effectivenes…

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