artificial intelligence Archives - Page 5 of 11

AI is part of Augmedics’ Xvision Spine System expansion

The Xvision Spine System. [Image from Augmedics]Augmedics announced today that it launched new, FDA-cleared features and indications for its Xvision Spine System.

Updates to Xvision come just weeks after the company hit its 3,000-patient milestone for the system. It marks Xvision’s largest expansion since its commercial launch.

Chicago-based Augmedics said in a news release that the launch creates a technical foundation for future platform developments, too.

Augmedics added new features including artificial intelligence (AI)-based image enhancement functionalities. Xvision now also features new customizable views to expand its advanced visualization and customization capabilities.

The system now includes new cervical and iliosacral indications, joining existing thoracic, lumbar and sacral indications. This expands Xvision navigation to cover nearly the entire spine. Surgeons can now utilize the advantages of its navigation in posterior cervical…

Proprio’s OR navigation system could improve orthopedic surgeries

Proprio designed its Paradigm system to help surgeons better visualize spinal surgeries. [Photo courtesy of Proprio]

Proprio is rolling its AI-powered surgical navigation system into operating rooms to collect data that will ultimately help surgeons improve how they perform procedures.

The Seattle-based startup said it has placed its Paradigm system in several U.S. operating rooms to capture surgical data that will useful for accelerating the system’s development.

“Our data-informed platform allows all members of the surgical team access to the right information, at the right time, in the right environment,” Proprio co-founder and CEO Gabriel Jones said in a statement. “By passively capturing data in the background of surgery, we understand and quantify surgery better and are positioned to create the most data-rich platform for surgeons.”

For now, the system’s s…

Philips highlights how it is bringing AI to MR

The MR 7700 imaging system. [Image from Philips]Philips (NYSE:PHG) today announced a range of artificial intelligence (AI)-based offerings it plans to present at the European Congress of Radiology (ECR) 2023.

The Amsterdam-based medtech giant plans to showcase its MR5300 and MR 7700 offerings, as well as its Spectral CT 7500 and Incisive CT with CT Smart Workflow. It also intends to highlight its DXR Smart Workflow, Ultrasound Compact 5000, Ultimate Ultrasound for liver assessment and EPIQ Elite.

MR 5300, powered by AI, simplifies and automates complex clinical and operational tasks to boost MR productivity. It also speeds up exam time and enhances clinical decision-making.

The MR 7700 offers enhanced imaging and speed to support confident diagnosis. It features up to 35% shorter scan time with higher diffusion image quality for all anatomies. MR 7700 also allows radiologists to image six different clinically relevant nuclei across all anatomies.

Spe…

Decode deaths with BERT to improve medical device safety and design

Michelle Wu is the founder and CEO of Nyquist Data. [Photo courtesy of Nyquist Data]

By Qiang Kou and Michelle Wu, Nyquist Data

A recent study shows that the number of death events in the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database has been vastly underestimated because many are not reported as deaths.

Lalani et al. manually reviewed 290,141 MAUDE reports and found that around 17% of the death events had been misclassified. That means the patient died, but the event was labeled as having “no consequences or impact to patient.”

The manual review requires expertise in different medical specialties and is too time-consuming to process millions of added reports. This problem can be viewed as a binary classification problem. And we can fine-tune the BERT model to solve it.

What is BERT?

BERT stands for Bidirectional Encoder Representations from Transformers. Rec…

Stryker on steroids: How enabling technology will supercharge surgical robotics

Robert Cohen is president of Stryker’s Digital Robotics and Enabling Technologies organization. [Photo courtesy of Stryker]

Stryker is tapping health data and artificial intelligence (AI) to improve surgical robotics outcomes.

Robert Cohen, president of Digital Robotics and Enabling Technologies at Stryker, recently discussed his mission with DeviceTalks Editorial Director Tom Salemi.

Stryker created the Digital Robotics and Enabling Technologies group in 2021 to “stay laser-focused on the technology,” Cohen said.

“What’s going on in the world of digital, what’s going on in the world of health records, what’s going on in the world of product security? How do we assure there’s no bias in algorithm development? We’re looking at local regulations as well as managing the R&D groups that are doing the robotics, the software, the navigation units for c…

How Google and iCAD will partner to advance AI mammography

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

iCAD will help Google Health get its AI mammography technology into clinical practice, while Google will help iCAD improve its algorithms and reach more patients through the cloud.

Google and cancer detection developer iCAD are teaming up on the development and commercialization of artificial intelligence (AI) for detecting breast cancer.

It’s Google Health’s first partnership with a mammography AI provider. The development and commercialization agreement is Google Health’s first deal to introduce its breast imaging AI into clinical practice through iCAD’s portfolio of AI products.

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

Nashua, New Hampshire-based iCAD (Nasdaq:ICAD) is licensing Google’s AI technology for breas…

What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage po…

Avail Medsystems plans to roll out first third-party software integration

The Avail Medsystems console brings remote experts into the operating room virtually. [Photo courtesy of Avail Medsystems]

Avail Medsystems is testing a third-party software integration that it plans to launch in the coming months.

Avail executives said they hope it will be the first of many partnerships with medical technology developers of software or algorithms that could be useful in the operating room.

Avail CEO Daniel Hawkins expects to launch the software integration in the first quarter of 2023, he told Medical Design & Outsourcing after a panel discussion at DeviceTalks West in Santa Clara, California. He declined to name his company’s partner, but offered some details as the product goes through UI and customer experience testing.

“A remote user can pull up that software and optimize the workflow in a specialty category that really benefits from workflow enhancement,̶…

Avail Medsystems plans to roll out first third-party software integration

The Avail Medsystems console brings remote experts into the operating room virtually. [Photo courtesy of Avail Medsystems]

Avail Medsystems is testing a third-party software integration that it plans to launch in the coming months.

Avail executives said they hope it will be the first of many partnerships with medical technology developers of software or algorithms that could be useful in the operating room.

Avail CEO Daniel Hawkins expects to launch the software integration in the first quarter of 2023, he told Medical Design & Outsourcing after a panel discussion at DeviceTalks West in Santa Clara, California. He declined to name his company’s partner, but offered some details as the product goes through UI and customer experience testing.

“A remote user can pull up that software and optimize the workflow in a specialty category that really benefits from workflow enhancement,̶…

FDA clears AI-enabled MR tech from Philips

MRCAT [Image from Philips]Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its AI-enabled MRCAT head and neck radiotherapy application.

Amsterdam-based Philips designed its MRCAT head and neck application to allow for the use of MR as the sole or primary imaging modality for radiotherapy planning. It is used for the treatment of soft tissue tumors in the head and neck, along with the brain, pelvis and prostate.

Through a development partnership with MacroMedics, Philips also announced the compatibility of its DSPS Prominent positioning system. DSPS (double shell positioning system) works with the MR head neck coil from Philips. Together, they offer soft tissue imaging capabilities with high-resolution image quality from the head and neck coil. It also features the comfort and positional accuracy and stability of MacroMedics’ masks.

“With this innovative mask that fits into Philips’ head coil, we expect to acquire head and n…

Can I get IP for my healthtech AI?

With healthtech AI investment booming, companies are seeking guidance on when and how to protect that work.

Andrew (A.J.) Tibbetts, Greenberg Traurig

(Image courtesy of the FDA)

Can you get intellectual property (IP) for artificial intelligence (AI)? Absolutely. Should you file a patent application? Maybe, but there are alternatives. Should you consider data options? Yes. Is there a standard strategy for AI? Not if you want to see value from your IP.

The healthtech industry is investing heavily in software engineering and data science as it increasingly develops decision support, medical telemetry, surgical navigation and countless other medical software applications. The software investments naturally raise questions on how best to protect against copycats. It is certainly wise to obtain IP for your AI and software, to protect market position or set partnership terms. But while protecting other tec…

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.

RELATED: FDA issues draft guidanc…