FDA releases top 3 medical device regulation goals

FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices.

Is tax reform good or bad for medical device companies?

Medical device companies and others in the healthcare sector stand to benefit from the tax reform Congress passed at the end of 2017, but the picture isn’t entirely rosy, according to a new report from S&P Global Ratings. In many ways, the report offers a corrective to the bullish statements coming from corporate CEOs such

FDA needs to improve medical device regulation, GAO says

FDA is lacking performance metrics when it comes to tracking whether its medical device regulators are following a “least burdensome” approach toward asking applicants for additional information, according to a new report from the U.S. Government Accountability Office. The GAO says in the report highlights: “Until such measures are developed and used, FDA will not

These nanosponges remove sepsis-causing bacteria from the bloodstream

California researchers have created a nanosponge that is designed to absorb and remove molecules that are known to cause sepsis. Researchers from the University of California at San Diego created macrophage nanosponges that are wrapped in the cell membranes of macrophages and can safely absorb and remove sepsis-causing molecules from the bloodstream. So far, the

Secant Group officials think they’ve cracked vascular regeneration: Here’s how

Secant Group today announced what it described as game-changing technology to advance vascular regeneration, solving problems that surgeons presently have when it comes to vascular harvesting and the non-resorbable synthetic graft compliance mismatching. The technology, which Secant (Telford, Pa.) developed in partnership with its sister company SanaVita Medical, involves a synthetic, small bore, vessel with a

Northwire expands biocompatibility compliance

Northwire (Osceola, Wis.) announced that it has finished additional testing to certify its BioCompatic material line to be in accordance with ISO 10993-10 irritation and skin sensitization requirements. The company’s BioCompatic material is designed to create optimized, safe and dependable medical cables while meeting biocompatibility standards under USP Class VI and compliance to ISO 10993-5 cytotoxicity.

Tobias Kuehnle named managing director of Trumpf Canada

Tobias Kuehnle will become the managing director of Trumpf Canada, effective April 1. Kuehnle succeeds Stefan Fickenscher, who became the sales director of the machine tool division in the U.S. at Trumpf starting on Jan. 1.  Fickenscher will be interim managing director of Trumpf Canada until Kuehnle takes over. Kuehnle joined Trumpf in 2006, starting out in

Murata Electronics touts Nordic-based BLE module for IoT solutions

Murata Electronics recently announced the release of MBN52832 – a Bluetooth Low Energy/NFC module that the company says enables ultra-low power connectivity for data communication. The miniaturized MBN52832 device consists of Nordic Semiconductor’s nRF52832 IC, a 32 MHz crystal for timing and an on-board antenna – packaged into a small form factor. The device also includes

Abbott, Nevro tout spinal cord stimulation tech

Abbott (NYSE:ABT) and Nevro (NYSE:NVRO) touted their spinal cord stimulation technologies at the annual North American Neurological Society meeting in Las Vegas. Two-year data from Abbott’s 42-patient Sunburst study revealed that a majority of patients chose its BurstDR therapy when given the choice during the long-term follow-up period and that stimulation from BurstDR provided pain relief […]

3D printing and cryogenics could create new potential for artificial organs

Researchers at Imperial College London have developed a technique to replicate biological structures using cryogenics and 3D printing. The research is a first from the university to create structure that are soft enough to replicate the mechanical properties of organs like the brain and lungs. The 3D printing technique could create replica organs and assist

CES 2018: Medical technologies you need to know

Updated Jan. 16, 2018 Mobile health devices and wearables have increasingly played a prominent role at the annual CES show in Las Vegas. Health and medical devices touted at CES 2018 sought to improve everything from heart health to posture. Here are 13 companies that exhibited digital health solutions at this year’s show. Next >>

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How medtech could stop the drug overdose crisis in the U.S.

The opioid epidemic is one of the deadliest problems facing the U.S. today. Through the development of new pain management devices, medtech could be a leader in solving the crisis. The prescription opioid overdose crisis in America didn’t start until the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive.

Medical Murray rolls out website redesign

Medical Murray has launched its newly redesigned website. The new design is made to offer more in-depth information, faster navigation and responsiveness. “We are extremely excited for the new website. The site clearly represents our brand, who we are today and how Medical Murray serves as an extension of our customers,” Eric Leopold, executive VP

Light-based medical products: What you need to know

Photonics technologies are everywhere but need a deft touch to integrate into light-based medical products. Scott Wohlstein, The Photonics Group Much like electronics is the study of the electron, photonics is the study of the photon and includes its generation/emission, transmission, detection and analysis. Incandescent/fluorescent light sources, UV lamps, lasers, LEDs, lenses, fiber optics, detectors

How laser marking could solve the medical device industry’s UDI challenges

Here are five ways that laser marking could provide advantages to medical device companies when it comes to meeting permanent marking requirements under FDA’s Unique Device Identification program. Ashir Thakore, SABIC As the U.S. Food and Drug Administration (FDA) implements its phased Unique Device Identification (UDI) program across medical device classes, OEMs are considering methods