Features

Features : Medical
MDUFA IV: Shorter Review Times, More Consistency, and More Oversight

The reauthorization of the Medical Device User Fee Amendments (MDUFA) brings more pressure for FDA to shorten its review times back to “historical norms” and to provide more consistency in the review process. And after the success of an independent review authorized in...

Features : Medical
The Next Industrial Revolution and What It Could Mean for Medical Device Manufacturing

The next industrial revolution is on its way. It is bringing innovative technologies that are available and proven and placing them in the modern manufacturing plants. The cloud, the Internet of Things, mobile computing technology, embedded computing, advanced...

Features : Materials
Silicone Adhesives for Medical Device Assemblies

Medical device assemblies present unique challenges beyond those associated with manufacturing and assembly of products for consumer and industrial applications. While sharing the need for ensuring reliable, robust seals or bonds with these industrial applications, medical applications are subject...

Features : Medical
Validating IFUs for Reprocessed Medical Devices

Incidents of nosocomial or healthcare acquired infections (HAIs) and bacteria that have become resistant to antibiotics (“superbugs”) are a concern for U.S. FDA. These ongoing incidents have heightened FDA’s attention to manufacturers of reprocessed medical devices. Manufacturers need to...

Products : Medical
New Products: December 2016 Medical Design Briefs

PRODUCT OF THE MONTH — AC/DC Power Supply

Power Partners, Athens, GA, has released a new AC/DC power supply from its medical open frame/u-channel product line. The BF-rated-output PPWAM360 series is designed to deliver 360 W in a high power density 4 × 6 in. footprint with 90–264 V...

Features : Medical
Real-World Evidence: Next Steps for the NEST Coordinating Center

FDA has awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the coordinating center for the medical device National Evaluation System for Health Technology (NEST). The funding will also be used to set in motion the group’s first...

Features : Electronics & Computers
Advances in Thermal Management Materials and Adhesives for Medical Electronics

The demand for thermal management materials and adhesives is driven by the unwanted and potentially harmful heat generated by ever-shrinking electronic components and systems in all areas of the electronics market, including medical. In recent years, more...

Features : Medical
Advanced Melt Flow Controls Of Servo Ultrasonic Welding For Medical Devices

Ultrasonic welding of thermoplastics has been widely used by the medical industry to assemble plastic parts and components in just seconds without additional consumables. Development of servo-driven ultrasonic welders introduces unique levels of control to the process....

Features : RF & Microwave Electronics
Essential Elements in Pump Selection for Surgical Ablation Applications

The use of radio-frequency (RF) ablation is an important and growing technique at the heart of many new medical treatments. This equipment uses RF energy to ablate or destroy unwanted tissues. When delivered via a catheter, it offers a minimally invasive treatment for a wide...

Features : Medical
Fully Calibrated MEMS-Based Single-Use Proximal Flow Sensors

In the past, the decision to opt for a particular flow sensing technology in respirators and ventilation devices was a painstaking and complex process. More recently, however, flow sensor solutions have emerged that provide a fully calibrated and temperature-compensated output...

Features : Medical
2016 Contest Winner Redefines the Way We Measure Blood Pressure

The 14th annual “Create the Future” Design Contest for engineers, students, and entrepreneurs worldwide, sponsored by COMSOL and Mouser Electronics, attracted more than 1,100 innovative product ideas from engineers and students in more than 71 countries. The Medical category...

Features : Medical
3D Textile Engineering

Secant Medical, Telford, PA, has developed 3D textile engineering technology by integrating traditional textile engineering with advanced biomaterials. By combining the spatial resolution capability with advanced bioresorbable polymers, the company uses its proprietary bioelastomer Regenerez® to assist in enhancing the...

Products : Medical
Product of the Month: LCP Monofilament

Zeus Industrial Products, Orangeburg, SC, has launched an MRI-compatible liquid crystal polymer (LCP) monofilament. This technology overcomes a significant limitation of other vascular visualization procedures and removes radiation exposure as a consequence. According to the company, the LCP monofilament...

Products : Medical
Fast-Curing Silicone

A high-temperature-resistant, flexible onepart silicone from Master Bond, Hackensack, NJ, is a one-part acetoxy type silicone system that meets USP Class VI specifications for biocompatibility and ISO 10993-5 testing for cytotoxicity. MasterSil 910Med is a translucent paste that also withstands many sterilization methods,...

Products : Medical
Fluorinated Solvents

AGC Chemicals Americas, Exton, PA, offers a series of fluorinated solvents that provide medical device manufacturers with a safer, highly effective and environmentally friendly alternative to halogenated solvents. The AsahiKlin™ AE-3000 Series of solvents are approved for use as precision cleaning solvents, defluxing...

Products : Electronics & Computers
External Power Supply

Sager Power Systems, Middleborough, MA, offers the ME60 Series of the SL Power family of medical-grade external power supplies. The 60- W ME Series meets IEC 60601-1-2, fourth edition, electromagnetic compatibility (EMC) requirements and are approved to AAMI ES/CSA C22.2/EN/IEC60601-1, third edition, with 2× Means of...

Products : Medical
Spot-Curing System

Dymax, Torrington, CT, has introduced a new smaller LED spot-curing system with unique curing flexibility. The BlueWave® MX-150™ system can be used as a benchtop unit or integrated into an automated system, and its LED emitters are available in 365, 385, or 405 nm wavelengths. The system is designed to offer higher, more...

Products : Medical
Rotary Indexing Ring

Weiss North America, Willoughby, OH, offers indexing rings, which feature a flat design and are suitable for ring-style chassis systems that can accommodate as many as 24 stations for assembly processes. The TR1100 indexing rings can have a central opening as large as 1750 mm. The dial ring has a minimum outside diameter of...

Products : Medical
PTFE C-Ring Seal

Bal Seal Engineering, Foothill Ranch, CA, has expanded its line of sealing products to include the spring-energized PTFE “C-ring” seal. This seal, which can be retrofit into grooves originally designed for elastomeric O-rings, offers improved performance and service life in hardware with large tolerance variations. The...

Products : Medical
PTFE C-Ring Seal

Bal Seal Engineering, Foothill Ranch, CA, has expanded its line of sealing products to include the spring-energized PTFE “C-ring” seal. This seal, which can be retrofit into grooves originally designed for elastomeric O-rings, offers improved performance and service life in hardware with large tolerance variations. The...

Products : Medical
Rapid Overmolding

Proto Labs, Maple Plain, MN, has expanded the company’s rapid injection molding offerings with an overmolding service. The new capability can produce from 25 to 10,000+ custom overmolded parts in 15 days or less. The company says the introduction of rapid overmolding gives designers and developers another option for making...

Products : Materials
High-Performance Materials

EpoxySet, Lincoln, RI, has released the the SetWORX™ line of high-performance materials, which were developed to be nonhazardous for shipping, thus reducing costs associated with hazardous materials. Most of the materials in the SetWORX line contain no BPA, tin, or phthalates. Examples included the SetWORX USEAL...

Products : Medical
VOC-Free Solvents

A line of solvent blends from Kyzen, Nashville, TN, is designed to replace AK225, nPB, TCE, and other undesirable solvents. The “clean and green” chemistries include Metalnox M6920, Metalnox M6922, and Metalnox M6900. Classified as a non-VOC chemistry, Metalnox M6920 is nonflammable and has a global warming potential of 1....

Products : Medical
Fanless Embedded System

American Portwell Technology, Fremont, CA, has released the RICH-33B0-8171, a fanless embedded system. The rugged and compact design of the embedded system offers low power consumption, making it ideal for medical applications. The RICH- 33B0-8171 is equipped with the Portwell WADE-8171 Mini-ITX board. Based on the...

Products : Sensors/Data Acquisition
Noncontact Magnetic Sensors

Steute Wireless, Ridgefield, CT, offers wireless, noncontact magnetic sensors. In the presence of their actuating magnet, the sensors send a unique, coded telegram to one or more compatible, easily-programmable receivers that accept up to 10 discrete telegrams per channel. The sensors are powered by a long-life,...

Products : Medical
Sigma-Delta A/D Converters

Analog Devices, Norwood, MA, has introduced a series of 24-bit simultaneous sampling sigma-delta A/D converters for wide-bandwidth, high-density healthcare equipment. The AD7768 series includes a power scalable modulator and digital filter on each channel to enable the synchronized, precise measurement of both ac and...

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How to Optimize Environmental Monitoring Using Direct Mass...

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How to Optimize Environmental Monitoring Using Direct Mass...

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Design and Simulation of an Inverter Power Module for Electric...