From the Editor : Software
From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase
From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase

The test phase of FDA’s Software Precertification (Pre-Cert) Program has hit its halfway point. The agency has released an update on its progress and the...

From the Editor — Digital Health: Lessons Learned So Far from FDA’s Test Phase
Features : IoMT
Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants
Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants

Now that medical devices are being labeled and uniquely identified to meet the requirements of the U.S. Food and Drug Administration (FDA) Unique Device Identifier...

Capturing Unique Device Identifier Data on Non-Sterile Orthopedic Implants
Features : Photonics/Optics
Effects of Tube Processing on the Fatigue Life of Nitinol: Part 1
Effects of Tube Processing on the Fatigue Life of Nitinol: Part 1

With medical devices approved for more demanding cardiovascular applications such as transcatheter aortic and mitral valve repair (TAVR/TMVR), the long-term structural...

Effects of Tube Processing on the Fatigue Life of Nitinol: Part 1
Features : Manufacturing & Prototyping
Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing
Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing

Orthopedic devices play a crucial role in providing pain relief, improving mobility, and enhancing the quality of life for patients suffering from musculoskeletal...

Industrial CT is Hip: Quality of Life Enhanced with Additive Manufacturing
Briefs : Design
Four Best Practices for Software Testing
Four Best Practices for Software Testing

Great quality assurance is what turns great software into great product. Testing is a crucial part of any software development process, whether to ensure safety in a medical device, to minimize risk...

Four Best Practices for Software Testing
Briefs : Wearables
Wearable System to Sense and Stimulate the Brain
Wearable System to Sense and Stimulate the Brain

A team of researchers from Carnegie Mellon University is starting a project to design and implement a noninvasive neural interface that can be used as a wearable device. This neural interface...

Wearable System to Sense and Stimulate the Brain
Briefs : AR/AI
Miniature Robot Could Check Colons for Early Signs of Disease
Miniature Robot Could Check Colons for Early Signs of Disease

Engineers have shown it is technically possible to guide a tiny robotic capsule inside the colon to take micro-ultrasound images. Known as a Sonopill, the device could one day...

Miniature Robot Could Check Colons for Early Signs of Disease
Briefs : Materials
Engineers 3D Print Flexible Mesh for Ankle and Knee Braces
Engineers 3D Print Flexible Mesh for Ankle and Knee Braces

Hearing aids, dental crowns, and limb prosthetics are some of the medical devices that can now be digitally designed and customized for individual patients, thanks to 3D printing....

Engineers 3D Print Flexible Mesh for Ankle and Knee Braces
R&D : Medical
Palm-Sized 3D Ultrasound for Scoliosis Mass Screening
Palm-Sized 3D Ultrasound for Scoliosis Mass Screening

Researchers have developed a first-of-its-kind palm-sized 3D ultrasound imaging system for radiation-free scoliosis assessment. Named “Scolioscan Air,” the system is designed to bring...

Palm-Sized 3D Ultrasound for Scoliosis Mass Screening
R&D : Wearables
Apple Watch Shows Promise in Detecting AFib
Apple Watch Shows Promise in Detecting AFib

Researchers presented study findings showing that the Apple Watch was able to detect atrial fibrillation (AFib) in people who received an alert of an irregular heartbeat. These findings highlight...

Apple Watch Shows Promise in Detecting AFib
R&D : Materials
Graphene Monolayer Improves Implantable Neurostim Devices
Graphene Monolayer Improves Implantable Neurostim Devices

One of the most commonly used elements in neurostimulation devices is platinum microelectrodes, but they are prone to corrosion, which can reduce the functional lifetime of the...

Graphene Monolayer Improves Implantable Neurostim Devices
R&D : Photonics/Optics
Virtual Biopsy Device Detects Skin Tumors
Virtual Biopsy Device Detects Skin Tumors

Using sound vibrations and pulses of near-infrared light, a new “virtual biopsy” device can quickly determine a skin lesion's depth and potential malignancy without using a scalpel. The...

Virtual Biopsy Device Detects Skin Tumors
R&D : AR/AI
AI Enables Low-Dose CT Scans
AI Enables Low-Dose CT Scans

Researchers have developed an artificial intelligence (AI) technique that uses image post-processing to rapidly convert low-dose computed tomography (CT) scans to images of superior quality, compared to low-dose...

AI Enables Low-Dose CT Scans
R&D : AR/AI
‘Stumbling Device’ Helps Improve Prosthetic Legs
‘Stumbling Device’ Helps Improve Prosthetic Legs

Researchers are addressing the tendency to stumble in lower-body prosthetics by understanding the way people with two legs catch themselves. They accomplished this by covering test...

‘Stumbling Device’ Helps Improve Prosthetic Legs
Products : Materials
New Products & Services: August 2019 Medical Design Briefs
New Products & Services: August 2019 Medical Design Briefs

Medical Device Manufacturing Software

Master Control, Salt Lake City, UT, has released a software platform designed to automate production and improve operational quality....

New Products & Services: August 2019 Medical Design Briefs
Products : IoMT
Product Focus: Connectors/Wires/Cables
Product Focus: Connectors/Wires/Cables

Female Cable Connector

Binder USA, Camarillo, CA has extended its M12-X product line with a female cable connector and RJ45 to female feedthrough for control cabinets. The M12 X-coded cable...

Product Focus: Connectors/Wires/Cables
Briefs : IoMT
Digitalizing Rehabilitation with Wearable Solutions
Digitalizing Rehabilitation with Wearable Solutions

ExoRehab is an IoT rehabilitation solution that combines robotics, gaming, and data analysis. Digitalizing physical therapy for muscle rehabilitation enables patients to acquire therapeutic...

Digitalizing Rehabilitation with Wearable Solutions
Briefs : Manufacturing & Prototyping
Advanced Design Tools for Additively Manufactured Medical Devices
Advanced Design Tools for Additively Manufactured Medical Devices

While the regulatory and validation burden can be high, it's not surprising that the medical device industry is one of the earliest adopters of additive manufacturing (AM, aka...

Advanced Design Tools for Additively Manufactured Medical Devices
Global Innovations : Materials
Flexible High-Energy Textile Lithium Battery Designed for Wearables
Flexible High-Energy Textile Lithium Battery Designed for Wearables

Researchers at Hong Kong Polytechnic University (PolyU) have developed a highly flexible, high-energy textile lithium battery that offers more stable, durable, and safe...

Flexible High-Energy Textile Lithium Battery Designed for Wearables
News : Mechanical & Fluid Systems
Lee Spring Acquires The Kirk-Habicht Company
Lee Spring Acquires The Kirk-Habicht Company

Lee Spring, maker of stock and custom springs, has announced the acquisition of The Kirk-Habicht Company. Kirk-Habicht, founded in 1907, is a manufacturer of custom springs operating in Rosedale,...

Lee Spring Acquires The Kirk-Habicht Company
News : Robotics, Automation & Control
First Successful Mind-Controlled Robotic Arm Without Brain Implants
First Successful Mind-Controlled Robotic Arm Without Brain Implants

A team of researchers from Carnegie Mellon University, in collaboration with the University of Minnesota, has made a breakthrough in the field of noninvasive robotic device...

First Successful Mind-Controlled Robotic Arm Without Brain Implants
News : Communications
Smart Textiles Boost Connectivity Between Wearable Sensors by 1,000 Times
Smart Textiles Boost Connectivity Between Wearable Sensors by 1,000 Times

Over the past decade, a major trend in electronics has been the development of sensors, displays, and smart devices that are seamlessly integrated onto the human body....

Smart Textiles Boost Connectivity Between Wearable Sensors by 1,000 Times
INSIDER : Medical
Electronic Skin Offers Exceptional Sense of Touch
Electronic Skin Offers Exceptional Sense of Touch

Robots and prosthetic devices may soon have a sense of touch equivalent to, or better than, the human skin with the Asynchronous Coded Electronic Skin (ACES), an artificial nervous system....

Electronic Skin Offers Exceptional Sense of Touch
INSIDER : IoMT
Bringing Blockchain to Healthcare
Bringing Blockchain to Healthcare

A kit made from everyday objects is bringing the blockchain into the physical world. The BlocKit, which includes items such as plastic tubs, clay discs, padlocks, envelopes, sticky notes, and battery-powered...

Bringing Blockchain to Healthcare
INSIDER : Photonics/Optics
Electronic Chip Mimics the Human Brain
Electronic Chip Mimics the Human Brain

Researchers have developed a device that replicates the way the brain stores and loses information. The technology creates opportunities to better understand how the brain is affected by disorders that...

Electronic Chip Mimics the Human Brain
News : Motion Control
Inside Story: Allied Motion
Inside Story: Allied Motion

Many medical devices — from robotic surgery to autonomous delivery robots in hospitals, to dialysis equipment — use motion control products to operate. Allied Motion’s long and successful experience as a...

Inside Story: Allied Motion
INSIDER : Wearables
At-Home Wearable Personalizes Tumor Therapy
At-Home Wearable Personalizes Tumor Therapy

A user-friendly vest worn at home uses technology that collects data to tailor personalized therapy for tumor patients. A lightweight, low-cost, wearable, patient-specific technology that will...

At-Home Wearable Personalizes Tumor Therapy
INSIDER : Medical
Superhydrophobic ‘Nanoflower’ For Biomedical Applications
Superhydrophobic ‘Nanoflower’ For Biomedical Applications

Researchers have developed a “lotus effect” by incorporating atomic defects in nanomaterials, which could have widespread uses including biosensing, lab-on-a-chip, and other...

Superhydrophobic ‘Nanoflower’ For Biomedical Applications
INSIDER : Medical
Nanoscale Army Records Intracellular Chatter
Nanoscale Army Records Intracellular Chatter

Soon, so-called brain-machine interfaces could: monitor and treat symptoms of neurological disorders like Parkinson’s disease, provide a blueprint to design artificial intelligence, or even...

Nanoscale Army Records Intracellular Chatter
Features : FDA/Regulatory
Why Cloud QMS Better Supports Regulatory Compliance
Why Cloud QMS Better Supports Regulatory Compliance

Companies regulated by the U.S. Food and Drug administration (FDA) need to establish current good manufacturing practices (CGMPs) as part of Title 21 CFR part 820 requirements. This...

Why Cloud QMS Better Supports Regulatory Compliance

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