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AI basics from Medtronic Chief Technology and Innovation Officer Ken Washington

Medtronic SVP and Chief Technology and Innovation Officer Ken Washington [Photo courtesy of Medtronic]

Medtronic SVP and Chief Technology and Innovation Officer Ken Washington was recently briefing the 15 general managers who run each of the operating units at the world’s largest medical device manufacturer.

In the middle of the first chart in his presentation on artificial intelligence, one of the leaders stopped him.

As Washington tells it, they said, “I just don’t understand all these different buzzwords around AI. Can you tell me what are the different types of AI? How does it all work? And what’s the difference between generative AI and deep learning?”

Washington — who joined Medtronic in June 2023 after serving as VP and GM of consumer robotics at Amazon and CTO at Ford Motor Co. before that — pulled out an easel, grabbed a marker, and walked the group through t…

The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

Using AI to unlock new uses for existing cancer medicines

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Repurposing is a drug development strategy that has been widely applied in cancer. This strategy, sometimes called label expansion, involves obtaining FDA approval to market a drug for the treatment of new indications, alone or in combination with other drugs. Not only can this approach extend the window of patent protection for a commercialized drug, but the path to regulatory approval can also be far less costly and risky than the traditional approach to drug development, largely because clinical evidence of safety already exists. And most importantly, the result is more and better treatment options for patients.

In keeping the law of unintended consequences, recent provisions introduced by the 2022 Inflation Reduction Act (IRA) blunted the potential benefits of drug repurposing. As a result of limiting the window of time during which pharmaceutical companies can recoup investments before…

AI boosts X-ray accuracy, cuts turnaround time in SimonMed study

A study of AI X-ray technology found fractures were diagnosed six times faster using AI than without. [Image by Issara via Stock.Adobe.com]

A study of artificial intelligence (AI) diagnosis tools for X-ray imaging found the technology delivered faster results and reduced the likelihood of missed fractures.

The new research was presented at the 2023 Radiological Society of North America’s Radiology Conference and Annual Meeting by SimonMed Imaging, one of the largest U.S. outpatient medical imaging providers and radiology practices.

Scottsdale, Arizona–based SimonMed said it conducted a retrospective study of data from its nationwide outpatient imaging centers, finding that AI automation technology delivered results 82% faster than readings without the technology. Fractures were diagnosed six times faster using the AI than without.

“Through the use of AI, we are not only able to help radiologists w…

EDC fading in prominence as AI and cloud gain ground

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In a year or two, the clinical trial industry may move beyond electronic data capture (EDC), a technology that has been the cornerstone of clinical data management for decades, projects Raj Indupuri, CEO of eClinical Solutions. Given the potential of electronic medical records (EMR) to feed directly into data infrastructure, the need for EDC may be moot — or at least diminished.

More automated data-collection processes

Already, clinical trials are pulling considerable data from external sources, whether that be outside labs providing supplemental test results or real-world data generated through biomarkers, genomics sequencing, wearables, and other sources circumventing conventional data capture processes.

“There’s more and more data that we’re collecting directly from patients or other sources,” Indupuri said. “And the amount of data that we’re collecting through EDC — or …

Medtech AI developer Ketryx raises $14M in Series A round led by Lightspeed

NEWS RELEASE: Ketryx raises $14M in Series A funding led by Lightspeed Venture Partners Investment fuels innovation to ensure patient safety and validate the use of AI in medical devices

BOSTON, Mass, December 5, 2023: Ketryx, provider of the first and only connected application lifecycle management software for the life sciences industry, today announced that it has raised $14 Million in Series A funding. The round was led by investor Lightspeed Venture Partners, with participation from existing investors including MIT’s E14 Fund and Ubiquity Ventures, bringing the total funding raised to date to over $18 Million. Lightspeed partner Guru Chahal will join the board. The new funds will be used to accelerate product development and commercial expansion.

The healthcare industry is embracing software and its promise to improve patient outcomes, including the power of Artificial Intelligence/Machine Learning (AI/ML). As a result, companies are grappling with how to main…

50 of the best-funded biotechs of 2023

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As the year draws to a close, it is clear that molecular science and diagnostics is the hottest funding area in the biotech industry. In an analysis of 50 of the best-funded biotechs of 2023 focused on human health, molecular and science and diagnostics startups collectively attracting roughly $945 million, dwarfing the figures in other segments. The next popular two niches, gene therapies and oncology, had average funding levels of approximately $245 million and $170 million, respectively. While AI has received a significant amount of attention this year, biotechs specializing in that field garnered an average funding of only about $66 million. Outside of the life sciences, startups with a broader focus on AI raised a cumulative average of $202.47 million, based on an analysis of close to 1000 companies.

Caris Life Sciences has raised nearly $1.7B to date

In terms of best-funded companies overall,…

Wearable developer Empatica aims to develop new digital biomarkers

Empatica Chief Medical Officer Dr. Marisa Cruz discusses advances in wearable technology and how new digital biomarkers could advance medtech.

Empatica Chief Medical Officer Dr. Marisa Cruz [Photo courtesy of Empatica]

Dr. Marisa Cruz envisions a future where unobtrusive wearable devices with advanced sensors will continuously measure and record actionable biodata without patients having to lift a finger.

Cruz is an endocrinologist and internist who serves as chief medical officer at Empatica, which develops wearable devices for monitoring patient physiology with the ultimate goal of improving clinical outcomes.

In 2011, Empatica spun out of an MIT lab focused on wearable sensors for continuous, passive patient monitoring. That technology is made possible by ever-shrinking sensors and batteries, gains in effective computing, and materials and manufacturing methods that result in comfortable and intuitive…

How a data lakehouse can give you a panoramic view of your AI-enabled clinical trials

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In recent years, the term “data lakehouse” has entered the lexicon of data professionals. For AI-enabled clinical trials, the lakehouse architecture promises seamless integration of diverse data streams, spanning patient health records to real-time sensor data, all processed efficiently and queried in structured formats.

The lakehouse architecture aims to provide a comprehensive overview of data, ensuring both vast storage and real-time processing capabilities. In other words, the lakehouse offers the “best of both worlds” when it comes to data warehouses and data lakes, according to Venu Mallarapu, vice president of global strategy and operations at eClinical Solutions.

AI and ML move from buzzwords to practical tools in clinical trial management

As the use of AI and ML in clinical trials becomes more prevalent in patient recruitment, real-time data monitoring and beyond, …

How the latest AI executive order might impact drug development in the U.S.

Image courtesy of Wikipedia

The White House has released an executive order that contains what it hails as “the most sweeping actions ever taken to protect Americans from the potential risks of AI systems.” Relevant to drug development, a fact sheet on the order describes its aim to help further “the responsible use of AI in healthcare and the development of affordable and life-saving drugs.” The order also is designed to protect against the risks of using AI to synthesize new chemicals and biological materials, and will require government agencies funding life science projects to follow these standards as a prerequisite.

Other provisions of the order that could affect drug developers include its potential to affect AI-assisted clinical trials. The order could require drug developers to ensure that their algorithms do not exacerbate discrimination in clinical trials or patient interactions. Drug …

9 tips for implementing AI in medical devices from a Medtronic executive

Patients and healthcare providers remain at the core of successful AI implementations in medtech. [piai/Adobe Stock]

It seems like artificial intelligence (AI) is ubiquitous in the healthcare landscape, but the technology remains nascent in the industry. Technologies ranging from machine learning to natural language processing and beyond promise to help make diagnoses and treatment more precise, efficient, and personalized.

But the allure of AI can sometimes overshadow the central goal of addressing tangible clinical problems.

During his talk at DeviceTalks West, Ha Hong, chief AI officer at Medtronic Endoscopy, underscored the importance of putting patients and healthcare providers at the forefront when incorporating AI into medical devices.

With a plethora of AI tools at our disposal — many of which are increasingly user-friendly — the onus is on us to wield them responsibly. Below, you’ll find …

Legal dispute precede Pfizer’s latest FDA nod for RSV vaccine

Amid a backdrop of recent RSV vaccine approvals, GSK and Pfizer find themselves locked in a legal spat over alleged patent infringements. Both Big Pharma giants now possess the FDA’s blessing for their respective respiratory syncytial virus (RSV) vaccines. Pfizer’s recent win came with the second approval for its Abrysvo vaccine, which the company now highlights as the first FDA-approved maternal vaccine to guard infants against RSV.

In early May, GSK’s Arexvy became the first to win FDA’s blessing to protect individuals aged 60 and above from RSV complications. By the end of the month, Pfizer had won approval for Abrysvo in the same age group.

Yet, behind the scenes of these approvals, legal clouds gather. GSK has taken its grievances to a federal court in Delaware, alleging that Pfizer infringed on four of its patents related to its Arexvy vaccine. In a Reuters-posted filing, GSK claims it began work on its RSVPreF antigen in the early 2000s. In th…