Baxter touts data supporting use of machine learning for infusion pump programming

Baxter (NYSE:BAX) announced today that data shows the potential for machine learning supporting decision-making with infusion pump programming.

Deerfield, Illinois-based Baxter presented the data from a retrospective study — part of a collaboration with MedAware aimed to develop next-generation dose error reduction software — at the American Society of Health-System Pharmacists (ASHP) 2021 Midyear Clinical Meeting.

Get the full story at our sister site, Drug Delivery Business News.

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9 predictions for pharma in 2022

Image courtesy of Pixabay

The pharma industry has been slower to embrace technologies such as AI and digital technology than many less-regulated sectors. The COVID-19 pandemic has changed the equation, forcing pharma companies to become more agile and open-minded in approaching drug discovery and development, including managing evolving clinical trials.

In this article, several experts offered their predictions of the trends that will be most meaningful in 2022.

1. Digital components drive new pharma value

Jaydev Thakkar

In 2022, a growing number of pharmaceutical companies will recognize how their products could deliver significantly improved outcomes with a digital component, predicted Jaydev Thakkar, chief operating officer of Biofourmis, which offers digital therapeutics and care-at-home solutions powered by AI. “This digital component c…

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The advantages of an AI/ML-enabled search engine for FDA records

(Image courtesy of the FDA)

The FDA’s exciting new list of artificial intelligence and machine learning-enabled devices highlights opportunity for improvement.

Craig Coombs and Qiang Kou, Nyquist Data

The FDA released a list of cleared or approved artificial intelligence and machine learning-enabled devices in September, documenting much of the agency’s work in the innovative area of AI/ML.

Extracting this information from the FDA’s decades-old database is labor-intensive at best — and often impossible. Despite the time spent by the FDA to make this new list, a lack of even text-based searching capability makes the list itself cumbersome and time-consuming to review.

Wouldn’t it be better if there was an AI resource that could quickly compile a list of FDA’s AI/ML clearances and approvals, allowing searches in seconds rather than hours?

Get the full story at our sister site, MassDevic…

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The advantages of an AI/ML-enabled search engine for FDA records

(Image courtesy of the FDA) The FDA’s exciting new list of artificial intelligence and machine learning-enabled devices highlights opportunity for improvement.

Craig Coombs and Qiang Kou, Nyquist Data

The FDA released a list of cleared or approved artificial intelligence and machine learning-enabled devices in September, documenting much of the agency’s work in the innovative area of AI/ML.

Extracting this information from the FDA’s decades-old database is labor-intensive at best — and often impossible. Despite the time spent by the FDA to make this new list, a lack of even text-based searching capability makes the list itself cumbersome and time-consuming to review.

Wouldn’t it be better if there was an AI resource that could quickly compile a list of FDA’s AI/ML clearances and approvals, allowing searches in seconds rather than hours?

Like many databases, the FDA database uses text-matching to find relevant entries. The weakness of text-matching…

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How Olympus is using AI to find patients for its COPD device

Olympus recently announced its SeleCT Connect program, which uses diagnostic imaging AI to automatically screen which people might benefit from its Spiration valve system.

Spiration is an FDA-designated breakthrough device for treating chronic obstructive pulmonary disease (COPD) patients.

SeleCT Connect — offered as part of Olympus’ SeleCT quantitative computer tomography (QCT) analysis service — is available immediately to more than 9,000 U.S. healthcare through the Nuance AI Marketplace, a workflow-integrated cloud platform for diagnostic imaging AI algorithms.

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

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How Olympus is using AI to find patients for its COPD device

Olympus recently announced its SeleCT Connect program, which uses diagnostic imaging AI to automatically screen which people might benefit from its Spiration valve system.

Spiration is an FDA-designated breakthrough device for treating chronic obstructive pulmonary disease (COPD) patients.

SeleCT Connect — offered as part of Olympus’ SeleCT quantitative computer tomography (QCT) analysis service — is available immediately to more than 9,000 U.S. healthcare through the Nuance AI Marketplace, a workflow-integrated cloud platform for diagnostic imaging AI algorithms.

Nuance Communications, which Microsoft is acquiring, and Olympus’ AI-based SeleCT analysis partner Imbio helped create the SeleCT Connect program.

SeleCT Connect automatically sends CT studies directly from physicians and radiologists’ picture archive and communication system (PACS) to the SeleCT QCT analysis service. Results automatically return to the patient record f…

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GE Healthcare turns to AI to boost MR for cancer therapy planning

GE Healthcare (NYSE:GE) recently announced that it has collaborated with Spectronic Medical to make AI-based software for more precise cancer treatment planning.

Spectronic Medical’s AI-based software can be used with GE Healthcare’s AIR Recon DL technology for MR-only based radiotherapy planning for better soft tissue differentiation than traditional CT.

About 60% of cancer patients require radiation therapy, which requires high-quality images to target lesions precisely and preserve healthy tissues. CT images are the gold standard for radiation, but they don’t have soft-tissue contrast.

“By using an MR image and creating a synthetic CT image, our MRI Planner software is designed to improve accuracy, increasing the precision by which radiotherapy can be delivered to the patient, as well as simplifying the physician’s workflow,” said Spectronic Medical CEO Carl Siversson. “Our customers say the benefits are enormous – it could increase …

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Latest iCad 3D mammography AI gains CE mark

iCad’s latest AI for digital breast tomosynthesis provides a case score for each detection. (Image courtesy of iCad)

iCad (NSDQ:ICAD) today announced that the third version of its ProFound AI for digital breast tomosynthesis (DBT) has won CE mark approval.

Compared with previous software versions, the latest generation of ProFound AI offers up to a 10% improvement in specificity performance while maintaining a high sensitivity level, and approximately 40% faster processing on the new PowerLook platform, according to the Nashua, N.H.–based company.

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

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How AI technology can democratize clinical trials in oncology

While drug developers continue to develop promising investigational cancer drugs, conducting clinical research in oncology remains difficult. Here’s how AI-enabled software can help. 

AI image courtesy of Pixabay

The statistics on inadequate trial recruitment and endemic challenges in oncology clinical trials are well known. They have only gotten worse over the past 20 years. While the number of cancer treatments has nearly quadrupled in that time period from 421 to 1,489, cancer drugs take 30–40% longer than other indications to gain approval and 80% of oncology clinical trials fail to meet enrollment timelines. Over this period, trial complexity has also increased due to more comprehensive trial designs (e.g., multi-cohort, basket and umbrella studies), precision medicine studies requiring gene, RNA or protein biomarker assays and the increasing quantity and sophistication of desired endpoints.

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Decentralized clinical trials continue to gain ground

[Photo by Laura James from Pexels]

The COVID-19 pandemic has led to fundamental changes in how pharmaceutical companies and physicians interact with patients.

And yet — for all of the talk about digital transformation, artificial intelligence (AI) and decentralized clinical trials in medicine in recent years — the adoption of those concepts has lagged. “The reality is that we’ve gone after shiny objects in many places,” said Dr. Nirav Shah, chief medical officer of Sharecare (Atlanta, Ga.).

The situation is, however, swiftly changing thanks to the pandemic. Some 44% of pharma, biotech and clinical research professionals have already adopted remote patient monitoring (RPM) or plan to do so in the next 12 months, according to a recent survey from VivaLNK (Campbell, Calif.). Almost two-thirds (65%) of survey respondents reported the pandemic was the primary driver of RPM adoption.

Physicians have w…

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AI-aided colon cancer tech gets FDA nod

Cosmo Pharmaceuticals announced today that it received marketing authorization for its GI Genius AI-based lesion detecting system.

GI Genius is an intelligent endoscopy system that uses AI/machine learning to detect lesions in the colon such as polyps or suspected tumors in real-time during a colonoscopy, according to a news release.

The device, which received FDA approval through the de novo pathway, is compatible with all endoscopes. Cosmo is the sole manufacturer, while Medtronic is the exclusive worldwide distributor.

Made up of hardware and software designed to highlight portions of the colon, the device uses AI algorithms to identify regions of interest where it may detect a potential lesion. GI Genius generates markers, which appear as green squares and are accompanied by a short, low-volume sound. It superimposes them on the video from the endoscope camera when a potential lesion is identified.

The device’s signals alert a clinician …

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FDA clears Activ Surgical hardware for enhanced surgical visualization

[Image courtesy of Activ Surgical]Activ Surgical announced today that it’s won FDA 510(k) clearance for ActivSight, the company’s intraoperative imaging module for enhanced surgical visualization.

Todd Usen, the Boston-based company’s CEO, described the clearance as “big news” in a LinkedIn post. “This clearance gets us one step closer to bringing our technology to ORs around the world and enabling real-time and best-in-class surgery for everyone,” Usen said.

The hardware-agnostic imaging module provides surgeons with real-time intraoperative visual data and imaging. Thirteen major healthcare systems around the world have so far committed to ActivSight’s initial launch, according to Activ Surgical. The company expects to launch ActivSight during the second half of 2021.

Activ Surgical plans for ActivSight to power its next product — ActivInsights. Included in the ActivEdge software platform, ActivInsights will…

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