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Cool! New energy-efficient R290 enclosure air conditioners

Seifert Systems introduces PFAS-free SoliTherm^® SlimLine NEO air conditioners using eco-friendly R290 refrigerant. These units offer high energy efficiency (EER up to 3.6) and a compact, under-8-in. internal depth. Featuring maintenance-free design with external or recessed mounting options, they deliver up to 8,500 BTU/hr, providing flexible cooling solutions for varied industrial enclosure needs. Several models available based on size/cooling capacity needs.
Learn more and see all your options.

Surface inspection: From Army depot to factory floor

Born from U.S. Army requirements for rotorcraft inspection, the GelSight Modulus 3D surface measurement system has surpassed 100 units sold to commercial and Department of Defense customers. The handheld, micron-scale tool with interchangeable probe tips delivers fast, high-res measurements in places traditional tools can't reach.
Read the full article.

What is Cold Metal Fusion?

Cold Metal Fusion is an open industry standard for sinter-based metal additive manufacturing. It combines polymer SLS design freedom with reliable debinding and sintering workflows, enabling complex geometries, lightweighting, lattice structures, conformal cooling channels, and high-precision metal parts with predictable shrink behavior. Now available from TriMech Group, this process offers a faster, cost-effective way to produce strong, high-performance metal parts.
Learn more from TriMech Group.

Cool! Internal threading in hard materials now possible

INSACO has a new capability where they can machine an internal thread in ceramic, sapphire, quartz, and other very hard materials. This advance pushes the boundaries of what's possible to support advanced applications that demand high precision and complexity. Ultra-hard materials are alternatives for when metal can't do the job. Ideal for aerospace, medical, and industrial applications.
Learn more. Video available on right side of page.

ClampDisk micro fastener is new alternative for automotive and consumer electronics

Designed as a unique alternative in assemblies for the automotive and consumer electronics markets, the ClampDisk Press-on Fastener is a newer offering from PennEngineering that delivers a fast, simple way to achieve sheet-to-sheet clamped fastening while replacing the use of standard screws, nuts, and adhesives. ClampDisk eliminates over-installation, cross-threading, stripped screw heads, broken screws, and damaged product. This fastener can be removed easily with a sharp-edged tool.
See how ClampDisk works.

Simplify appliance glass assembly

Henkel's Technomelt PUR 9015 BV/WV is a polyurethane hotmelt adhesive providing high initial strength and long-term durability for glass and large-panel appliance assembly. It enables immediate handling, excellent substrate adhesion, and high thermal resistance, while supporting automated, cost-efficient production. It offers a flexible solution for high-reliability manufacturing.
Learn more.

Made-to-order stamped components for insert molding

Traditionally, OEMs source metal inserts and insert molding services separately. Not anymore. Plastics manufacturers and injection molders are now taking on more of the sourcing responsibility for insert molded parts, and they are partnering with Boker's, who has a long-term proven record for delivering precision stampings with quick turnaround times and ensuring metal inserts are mold-ready upon delivery. Boker's has immediate access to over 2,000 commonly specified and hard-to-find materials.
Learn more.

SDP/SI Shaftloc Fastening System

Shaftloc is a unique, reusable locking device for securely mounting mechanical components like gears and sprockets onto shafts without the need for keyways, set screws, or adhesives. Its simple, two-piece design offers a cost-effective alternative to traditional fasteners, providing high clamping force and vibration resistance. Installed with standard tools, Shaftloc is perfect for designers seeking flexible, hubless mounting solutions. Available in four styles.
Learn more from SDP/SI.

Epoxy engineered for heat-sink bonding

Master Bond EP54TC is a two-component epoxy engineered for heat-sink bonding and thermal management applications. Featuring the highest thermal conductivity in the Master Bond electrically insulating portfolio, it delivers exceptional heat dissipation while remaining electrically non-conductive and compliant with ASTM E595 NASA low outgassing requirements. It supports thin bond lines and efficient void filling to maximize thermal performance.
Learn more.

Metal 3D printing: Right at your desktop

From prototyping to tooling or batch production of end-use parts, the Studio System 2 from Desktop Metal brings metal 3D printing to any office, studio, or lab setting. This powder- and laser-free system consists of an easy-to-adopt two-step process: print using pre-bound metal rod feedstock and then sinter. It requires minimal training and operator intervention. Combined with next-gen Separable Supports and a software-controlled workflow, the Studio System makes metal 3D printing simpler than ever. This platform offers more materials than any other metal extrusion 3D-printing system on the market, including Inconel 625, titanium (Ti64), copper, tool steels, and stainless steels.
View the video and learn more.

Metal 3D printing: EOS adds four new materials

Industrial 3D-printing supplier EOS has added four new metal additive manufacturing materials to its portfolio: an iron-nickel alloy that boasts stability under fluctuating temps, a nickel alloy with high strength and extreme corrosion resistance, a low-alloyed steel prized for its high toughness and strength, and an industrial-grade stainless steel. Each has been optimized for EOS Laser Powder Bed Fusion systems.
Get all the details.

Application Note: Disc springs in mechanical braking system

Braking systems for off-highway equipment are commonly designed to be hydraulically actuated, but without an additional fail-safe system, this design alone has limited reliability. If a hydraulic seal is compromised, or the hydraulic cylinder loses pressure for any reason, the brakes fail. One solid mechanical back-up design uses SPIROL disc springs.
Read the full article.

Configurable welding platform for flexible manufacturing

Emerson's new Branson Polaris Ultrasonic Welding Platform offers a highly configurable, smart solution for advanced manufacturing. It features secure connectivity and real-time control to join diverse materials, from medical devices to food packaging. With adaptable power supplies and actuators, the system scales from benchtop lab trials to fully automated production lines, optimizing footprint and data storage to meet complex application needs.
Learn more.

SPIROL receives 2025 Supplier Excellence Recognition Award from Caterpillar

Kudos to SPIROL! The engineered fasteners manufacturer has received the 2025 Supplier Excellence Recognition Award from Caterpillar Inc. This prestigious award recognizes suppliers who demonstrate world-class performance and a sustained commitment to quality, delivery, and operational excellence.
Read the full article.

Eliminate cotters, bolts, nuts with SLIC Pin^®

The SLIC Pin (Self-Locking Implanted Cotter Pin) from Pivot Point is a pin and cotter all in one. This one-piece locking clevis pin is cost saving, fast, and secure. It functions as a quick locking pin wherever you need a fast-lock function. It features a spring-loaded plunger that functions as an easy insertion ramp. This revolutionary fastening pin is very popular and used successfully in a wide range of applications.
Learn more.

Eye-opener: Almost half of FDA-approved AI medical devices are not trained on real patient data

By Kendall Daniels, University of North Carolina Health Care

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor removal accuracy. Despite their potential benefit to doctors and patients alike, these tools have been met with skepticism because of patient privacy concerns, the possibility of bias, and device accuracy.

In response to the rapidly evolving use and approval of AI medical devices in healthcare, a multi-institutional team of researchers at the University of North Carolina (UNC) School of Medicine, Duke University, Ally Bank, Oxford University, Colombia University, and University of Miami have been on a mission to build public trust and evaluate how exactly AI and algorithmic technologies are being approved for use in patient care.

Together, Sammy Chouffani El Fassi, an MD candidate at the UNC School of Medicine and research scholar at Duke Heart Center, and Gail E. Henderson, PhD, professor at the UNC Department of Social Medicine, led a thorough analysis of clinical validation data for 500+ medical AI devices, revealing that approximately half of the tools authorized by the U.S. Food and Drug Administration (FDA) lacked reported clinical validation data. Their findings were published in Nature Medicine.

"Although AI device manufacturers boast of the credibility of their technology with FDA authorization, clearance does not mean that the devices have been properly evaluated for clinical effectiveness using real patient data," said Chouffani El Fassi, who was first author on the paper. "With these findings, we hope to encourage the FDA and industry to boost the credibility of device authorization by conducting clinical validation studies on these technologies and making the results of such studies publicly available."

Since 2016, the average number of medical AI device authorizations by the FDA per year has increased from 2 to 69, indicating tremendous growth in commercialization of AI medical technologies. The majority of approved AI medical technologies are being used to assist physicians with diagnosing abnormalities in radiological imaging, pathologic slide analysis, dosing medicine, and predicting disease progression.

Artificial intelligence is able to learn and perform such human-like functions by using combinations of algorithms. The technology is then given a plethora of data and sets of rules to follow, so that it can "learn" how to detect patterns and relationships with ease. From there, the device manufacturers need to ensure that the technology does not simply memorize the data previously used to train the AI, and that it can accurately produce results using never-before-seen solutions.

Regulation during a rapid proliferation of AI medical devices
Following the rapid proliferation of these devices and applications to the FDA, Chouffani El Fassi and Henderson et al. were curious about how clinically effective and safe the authorized devices are. Their team analyzed all submissions available on the FDA's official database, titled "Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices."

"A lot of the devices that came out after 2016 were created new, or maybe they were similar to a product that already was on the market," said Henderson. "Using these hundreds of devices in this database, we wanted to determine what it really means for an AI medical device to be FDA authorized."

Of the 521 device authorizations, 144 were labelled as "retrospectively validated," 148 were "prospectively validated," and 22 were validated using randomized controlled trials. Most notably, 226 of 521 FDA-approved medical devices, or approximately 43%, lacked published clinical validation data. A few of the devices used "phantom images" or computer-generated images that were not from a real patient, which did not technically meet the requirements for clinical validation.

Furthermore, the researchers found that the latest draft guidance, published by the FDA in September 2023, does not clearly distinguish between different types of clinical validation studies in its recommendations to manufacturers.

Types of clinical validation and a new standard
In the realm of clinical validation, there are three different methods by which researchers and device manufacturers validate the accuracy of their technologies: retrospective validation, prospective validation, and subset of prospective validation (called randomized controlled trials).

Retrospective validation involves feeding the AI model image data from the past, such as patient chest x-rays prior to the COVID-19 pandemic. Prospective validation, however, typically produces stronger scientific evidence, because the AI device is being validated based on real-time data from patients. This is more realistic, according to the researchers, because it allows the AI to account for data variables that were not in existence when it was being trained, such as patient chest X-rays that were impacted by viruses during the COVID pandemic.

Randomized controlled trials are considered the gold standard for clinical validation. This type of prospective study utilizes random assignment controls for confounding variables that would differentiate the experimental and control groups, thus isolating the therapeutic effect of the device. For example, researchers could evaluate device performance by randomly assigning patients to have their CT scans read by a radiologist (control group) versus AI (experimental group).

Because retrospective studies, prospective studies, and randomized controlled trials produce various levels of scientific evidence, the researchers involved in the study recommend that the FDA and device manufactures should clearly distinguish between different types of clinical validation studies in its recommendations to manufacturers.

In their Nature Medicine publication, Chouffani El Fassi and Henderson et al. lay out definitions for the clinical validation methods that can be used as a standard in the field of medical AI.

"We shared our findings with directors at the FDA who oversee medical device regulation, and we expect our work will inform their regulatory decision making," said Chouffani El Fassi. "We also hope that our publication will inspire researchers and universities globally to conduct clinical validation studies on medical AI to improve the safety and effectiveness of these technologies. We're looking forward to the positive impact this project will have on patient care at a large scale."

Algorithms can save lives
Chouffani El Fassi is currently working with UNC cardiothoracic surgeons Aurelie Merlo and Benjamin Haithcock as well as the executive leadership team at UNC Health to implement an algorithm in their electronic health record system that automates the organ donor evaluation and referral process.

In contrast to the field's rapid production of AI devices, medicine is lacking basic algorithms, such as computer software that can diagnose patients using simple lab values in electronic health records. Chouffani El Fassi says this is because implementation is often expensive and requires interdisciplinary teams that have expertise in both medicine and computer science.

Despite the challenge, UNC Health is on a mission to improve the organ transplant space.

"Finding a potential organ donor, evaluating their organs, and then having the organ procurement organization come in and coordinate an organ transplant is a lengthy and complicated process," said Chouffani El Fassi. "If this very basic computer algorithm works, we could optimize the organ donation process. A single additional donor means several lives saved. With such a low threshold for success, we look forward to giving more people a second chance at life."

Published September 2024

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