Medical Design and Outsourcing Archives - Page 4 of 154

Researchers develop magnetically controlled microrobot for brain surgery

Microrobotic catheter with helical surface in a blood vessel model. [Image courtesy of ETH Zurich/Marco Rosasco Photography]

A team at ETH Zurich is working on microrobotic catheters controlled by a robotic field that could optimize catheter navigation in endovascular procedures.

Led by Brad Nelson, professor in the Multi-Scale Robotics Lab (MSRL) at ETH Zurich, the team hopes to tackle what they believe is the biggest challenge in removing blood clots blocking blood flow to the brain during stroke — the complex structure of the blood vessels.

In the technology developed by this team, the patient lies next to a navigation system that generates a directed magnetic field. The team’s microrobotic catheter features a diameter measuring at less than one millimeter and a soft magnetic tip. This magnetic catheter tip can be steered in all directions using control software. ETH Zurich’s team says th…

New Wyss project aims to control exosuit with brain signals

Researchers at the Wyss Center work on the Synapsuit exosuit project. [Image courtesy of Wyss Center]

Researchers at the Wyss Center have an ongoing project to develop AI algorithms that use brain signals to control a lightweight exosuit.

The Synapsuit project aims to develop high-performance algorithms that decode complex brain signals. In turn, these signals control a lightweight, soft, wearable exosuit that supports arm and hand movement in real-time. The Wyss team collaborates with local and international partners on this project aimed at accelerating neuro-rehabilitation.

“Neuroscience is rapidly merging with AI, allowing us to discover important patterns hidden inside seemingly chaotic brain signals,” said Dr. Kyuhwa Lee, principal investigator, Wyss Center. “Using cutting-edge machine learning approaches, we aim to translate movement intentions into action for people living with moveme…

Surgical robots don’t improve knee surgery revision rates, study says

[Image from Pixabay]

Robotically assisted total knee arthroplasty has skyrocketed in popularity, but a new registry data analysis raises some questions about the benefits for knee surgery patients.

The analysis of American Joint Replacement Registry (AJRR) data, presented at AAOS 2024 in San Francisco, found that revision rates were similar in conventional and robotic-assisted cementless TKA at two years post-operatively. The study also found that the odds of revision due to infection or mechanical loosening were not significantly different between the two methods.

“A lot of single surgeon studies show there is improved precision with robotic-assisted TKA,” Dr. Lucas Nikkel, assistant professor of orthopedic surgery at Johns Hopkins Medicine, said in a news release about the study. “Some studies suggest there may be improved early recovery or less damage to soft tissue. One of the chall…

Small patients, big design challenges: Pediatric device experts guide engineers on solutions

Abbott’s Amplatzer Piccolo — designed for catheter delivery inside an infant’s heart — is among the smallest pediatric devices ever made. [Image courtesy Abbott]

“What sets pediatric devices apart? It’s about giving children a chance at a full life,” said Dr. Lars Søndergaard, divisional VP of medical affairs and chief medical officer for Abbott’s Structural Heart division. “The solutions we design can’t just tackle the issue at hand — they need to enable normal development and stand the test of time across decades of life.”

Unlike the predictable anatomies of adults, young patients — some barely larger than the palm of a hand — are constantly changing, and those changes need to be accounted for in the long-term efficacy of the device. And though the challenges are substantial, the reward is immense. Successfully addressing an unmet need in pediatric care not only offer…

Researchers use neural prosthetic device for recall of specific memories

[Image from Milad Fakurian on Unsplash]

Researchers at Wake Forest say they successfully implemented a prosthetic system that uses a person’s own memory patterns. This system facilitates the brain’s ability to encode and recall memory.

A team at Wake Forest and USC, led by Robert Hampson, first reported a study of this type of technology in 2018. In that previous study, the team based its electronic prosthetic system on a multi-input, multi-output (MIMO) nonlinear mathematic model. Researchers influenced the firing patterns of multiple neurons in the hippocampus, a part of the brain involved in making new memories.

Researchers now built a new model of processes that assists the hippocampus, helping people remember specific information. The team used recordings of neural activity in brain cells to create a memory decoding model (MDM). It let them decode what neural activity is used to store di…

DeviceTalks Boston 2024: Our favorite panels and new additions

Our team picks favorites from our upcoming show, including some new additions to the program.

Leaders from CMR Surgical, the developer of the Versius surgical robotics system, will speak at DeviceTalks Boston 2024. [Photo courtesy of CMR Surgical]

I enjoy reading bookstore staff recommendations. It’s nice to see how people in the know like to spend their time.

But if you asked me to pick my favorite panels on the agenda for DeviceTalks Boston, taking place May 1–2, 2024 at the Boston Convention & Exhibition Center, I couldn’t do it.

In fact, I won’t do it. Sorry, dear reader, I’ve put too much into this agenda to pick one favorite session. Plus, I owe neutrality to our speakers — amazing professionals willing to give up two days to help me create something. That’s a covenant that I cannot violate by selecting a favorite.

But I can put our editorial team on the spot to pick their favorites. And…

Abbott and Fujirebio work on neurological biomarker assay for researchers

Abbott announced that it entered into a partnership with Fujirebio to develop a research use only neurofilament-light chain (Nf-L) neurology biomarker assay.

The companies partnered to create this assay for use on Abbott’s Alinity i instruments. Abbott plans to make the assay available to researchers conducting studies demonstrating the utility of the Nf-L biomarker. Research with this biomarker is already ongoing in a variety of neurological diseases, according to a news release, including multiple sclerosis, Alzheimer’s, traumatic brain injury and cognitive impairment.

Abbott and Fujirebio plan to make this assay available for Alinity i by 2025. It’s the first research use only assay set to be brought to the Alinity i system. Abbott wants to explore the research use pathway for other new biomarkers to support the research community through Alinity i. It hopes to enable the faster development of diagnostics and therapeutics.

Fujirebio Presid…

DDL adds CT scanning for medical connector testing

NEWS RELEASE: DDL Enhances its Medical Connector Testing Capabilities with the Addition of Industrial CT Scanning Technology for Dimensional Analysis

The addition of CT scanning capabilities makes DDL the only third-party lab to offer both mechanical testing and dimensioning services for ISO 80369 compliance in-house.

[Image courtesy of DDL]

Eden Prairie, MN – DDL, a third-party testing laboratory, announced it has enhanced its medical connector testing capabilities with the addition of Industrial CT scanning to provide dimensional testing to meet the exacting dimensional criteria outlined in the ISO 80369 standard.

ISO 80369 is a set of standards created for small-bore connectors utilized in healthcare applications, encompassing the Luer Lock design. Adhering to these standards empowers medical device manufacturers to ele…

The FDA is issuing cybersecurity deficiency letters — here’s how to make sure you don’t get one

A former FDA reviewer shares insights into the depth and breadth of FDA cybersecurity deficiencies that could sink your device.

Naomi Schwartz, Medcrypt

[Image by Angelov via Stock.Adobe.com]

As of Oct. 1, 2023, the FDA enacted its Cybersecurity Refuse to Accept (RTA) policy, turning away any medical devices that do not meet its premarket and postmarket cybersecurity guidance. And earlier, in June 2023 the FDA released final guidance about the Electronic Submission Template and Resource (eSTAR) program which requires all relevant cybersecurity information to be completed, effectively signaling a new era of regulatory accountability.

With the FDA’s increased cybersecurity authority and resulting enforcement, medical device manufacturers must now comply with FDA mandates. In years leading up to recent regulations, the FDA used a more idiosyncratic and educative carrot approach, providing guidance and…

Moticont launches new miniature direct drive linear motor

NEWS RELEASE: Miniature Direct Drive Linear Motor with Integrated Encoder and Temperature Sensor is Just 16 mm in Diameter!

The Moticont SDLM-016-032-01-01 direct drive linear motor [Image courtesy of Moticont]

Van Nuys, CA – Moticont is introducing their new miniature 16 mm diameter SDLM-016-032-01-01 Direct Drive Linear Motor with integrated position and temperature sensors. This smallest of the fully enclosed SDLM series of linear motors features zero backlash, zero cogging, high acceleration, high speed, high resolution, and long life. Also known as an electric cylinder, this compact direct drive linear motor is just 16.0 mm (0.625 in.) in diameter and 31.8 mm (1.25 in.) long. Protected inside the motor housing, the linear optical quadrature encoder is directly connected to the shaft for the greatest possible accuracy. Highest throughputs are achieved by the SDLM-016-032-01-01 linear motor when operating at pea…

Who is Acquandas? Its thin film manufacturing goes beyond Synchron

This nitinol thin film actuator made by Acquandas with a film thickness of 50 µm can pull 550 times its own weight. [Image courtesy of Acquandas]

Acquandas is a thin-film device manufacturer that’s now partially owned by brain-computer interface developer Synchron.

Rodrigo Lima de Miranda founded Acquandas in 2012 based on microsystem technology he developed for his doctoral thesis, where he was trying to develop a shape memory material made with thin-film deposition.

The Kiel, Germany-based contract manufacturer now uses the Nanolab cleanroom facilities at Kiel University and is growing its team of around 22 employees.

Beyond neurotech applications like Synchron’s Stentrode, the Acquandas technology has promising potential for cardiac ablation, renal denervation, opthamology, nerve stimulation, passive microimplants, microneedles, and smart actuators and springs, Lima de Miranda said …

Freudenberg Medical establishes second production facility in Costa Rica

NEWS RELEASE: Freudenberg Medical establishes second production facility in Costa Rica $25 million investment to meet growing global demand for medical devices and precision components Expansion to quadruple manufacturing footprint for high volume minimally invasive catheters Creation of 600 new jobs, fostering growth for local community

Coyol, Costa Rica, February 12th, 2024. Freudenberg Medical, a global contract design and manufacturing (CDMO) partner to the medical device and biopharma industry with facilities in key industry hubs across the Americas, Europe and Asia, announced it is to establish a second manufacturing site in Costa Rica. With this $25 million investment the company is expanding its technologies to deliver increasingly complex products to its global customer base.

“We are proud to be one of the first global CDMO partners in Costa Rica, having established our first production facility here more than 12 years ago,” said Dr. Mark Ostwald, CEO of Fr…