Certol International LLC

FDA clears MiRus expandable lumbar system MiRus today said it received FDA 510(k) clearance for its IO expandable lumbar interbody. Marietta, Georgia-based MiRus designed the expandable lumbar interbody to be used in PLIF and TLIF procedures. It has a low insertion profile at 4 mm, an expansion of 18 mm and a 24º lordosis. “The FDA approval of the IO expandable… […] Tyber Medical’s anatomical plating system wins FDA clearance Tyber Medical today said it received FDA 510(k) clearance for its expanded line of anatomical plating system. The Bethlehem, Pennsylvania-based Tyber Medical added mini-frag/small bone, long bone fracture and ankle fracture/fusion plates to its offering following the FDA clearance. The company designed the system to address the stabilization of fractures, osteotomies, joint fusions, non-unions and… […] Intelivation Technologies wins FDA approval for pedicle screw system Intelivation Technologies today announced that it has received FDA 510(k) clearance for its Golden Isles pedicle screw system. The Saint Simons Island, Georgia-based company designed the Golden Isles system to provide immobilization and stabilization of spinal segments in skeletally mature patients to treat the lumbar and sacral spine. It is intended for use in posterior,… […] Jury selection for Elizabeth Holmes fraud trial begins today Jury selection for ex-Theranos CEO Elizabeth Holmes’ federal fraud trial is set to begin today in U.S. District Court in San Jose, California. Holmes faces 10 counts of wire fraud and two counts of conspiracy to commit wire fraud over allegations that she knowingly misled investors by claiming Theranos technology could revolutionize blood testing. She… […] Connected workers are key to meeting medical device manufacturing demands Here’s how medical device manufacturers can navigate the “year of the connected worker.” Louis Columbus, Delmiaworks Perhaps the only thing that medical device companies and contract manufacturers can predict for 2021 will be continued unpredictability across supply chains, market demand, sales forecasts, and skilled workers’ availability. In the United States, elective surgeries are on the… […] Abbott touts Amplatzer Amulet results in head-to-head trial with Boston Scientific’s Watchman Abbott (NYSE:ABT) is claiming a big win for its Amplatzer Amulet device in a head-to-head trial with Boston Scientific’s (NYSE:BSX) Watchman. Late-breaking data presented at the European Society of Cardiology Congress and simultaneously published in Circulation support the FDA’s recent approval for the Amplatzer Amulet, Abbott said in a news release. The Amplatzer Amulet Left Atrial Appendage (LAA) Occluder is a… […] 3 questions medical device manufacturers should ask before ISO 10993-17 updates The upcoming publication of ISO 10993-17 will support the latest ISO 10993 expectations already in place. Gain insights into what this standard will mean to the evaluation process and how to prepare in advance. Sherry Parker, WuXi AppTec Medical Device Testing Following ISO 10993-1, the lens of medical device biological safety evaluation changed to a… […] Does your human factors drive design, or does your design drive human factors? A solid commitment to human factors in the design process can be critical to a medical device’s success. MaryBeth Privitera, HS Design, a SteriPack company In some early education circles, there is a philosophy that one can learn from testing. If you want a child to know vocabulary words, you can have them briefly study,… […] MicroCare acquires Certol International MicroCare has acquired Certol International, a Denver-based manufacturer of specialty cleaning and disinfecting products. New Britain, Connecticut-based MicroCare said in a news release that the acquisition aligns with its strategic goals and priorities to fuel growth by delivering innovative, value-added solutions and services to the global critical cleaning industry. Certol’s leading product and development initiatives… […] Quest Industrial launches new pallet-packing Box Bot The maker of a system that robotically packs pallets for tractor-trailer shipping has released a simpler version to appeal to a wider range of manufacturers. Quest Industrial says its standardized Box Bot QB300 has the same features and benefits as the original Box Bot, but is built for manufacturers that don’t need much additional customization.… […]

MicroCare acquires Certol International MicroCare announced that it acquired Certol International, a manufacturer of specialty cleaning and disinfecting products. New Britain, Conn.-based MicroCare said in a news release that acquiring the Denver-based manufacturer aligns with its strategic goals and priorities to fuel growth through the delivery of innovative, value-added solutions and services into the global critical cleaning industry. Certol’s… […] Quest Industrial launches new pallet-packing Box Bot The maker of a system that robotically packs pallets for tractor-trailer shipping has released a simpler version to appeal to a wider range of manufacturers. Quest Industrial says its standardized Box Bot QB300 has the same features and benefits as the original Box Bot, but is built for manufacturers that don’t need much additional customization.… […] Overcoming vaccine delivery device design’s top challenges Vaccine delivery has long been a hot topic and only got hotter in the ongoing push to vaccinate against COVID-19 around the world. Most would probably associate vaccines with the standard “jab” injection with a syringe. Over the past year and more, companies have touted ideas for other avenues. Inovio has a “smart” delivery device for… […] This steerable catheter for the brain could improve aneurysm treatment Researchers at the University of California in San Diego have developed a way to make steerable catheters that can precisely navigate the brain vasculature. The team of researchers designed the device to navigate the brain’s arteries and blood vessels to treat aneurysms and other neurological conditions. It was inspired by insect legs and flagella tail-like… […] Taking the extra steps to ensure medical device quality assurance Here’s how medical device manufacturers can go the extra mile to address regulatory challenges and user needs with comprehensive and purposeful quality assurance systems. Judith Antler, Eitan Medical Quality assurance (QA) control is a central component of any manufacturing process, ensuring the end product is reliable, safe and of the highest quality. This process is… […] Ramping up manufacturing for single-use surgical instruments: What you need to know Manufacturers can optimize functionality, use and volume to deliver high-performing, high-quality single-use surgical instruments to customers. Steve Santoro, Micro Surgeons and hospitals increasingly need single-use surgical instruments — as they offer several distinct advantages over reusable products. Disposable instruments designed for single-use don’t need to undergo expensive and time-consuming cleaning, sterilization and reprocessing. Reusable instruments… […] How to evaluate laser performance for medical device manufacturing Laser processing provides automation and efficiencies that help meet FDA regulations and produce superior medical device components. David Locke, ACSYS Lasertechnik US Laser systems have become essential to the production of better-designed medical devices. The precision, repeatability, and scale needed to manufacture next-generation medical products rely heavily on lasers’ advantages to contract manufacturers and medtech… […] Amazon makes moves for a major medical diagnostics play Amazon (NASDAQ: AMZN) wants to hire key employees to expand its medical diagnostics operations on a global scale, which very well could grow beyond COVID-19 testing. Senior-level job postings offer a glimpse of the notoriously secretive and ambitious tech company’s global aspirations for medical diagnostics. Just this week, Amazon put a call out for a… […] Here’s how you achieve proactive product development Use strategic collaboration to overcome these five common medtech product development challenges. Overcoming product-development barriers — the topic of a recent Device Talks Tuesdays webinar sponsored by Celestica — requires the elimination of design silos and the embracement of partnering opportunities. So how does this happen? Kevin Walsh, VP of Celestica’s HealthTech Division, and Kevin McFarlin, engineering director, had some answers.… […] Where are IoMT-based wearables going next? Here are three significant trends shaping the Internet of Medical Things (IoMT) space. Christopher Montalbano, MIDI Medical Product Development Home healthcare is an industry that has seen rapid growth in the past decade, with consumers taking more interest now than ever in understanding, maintaining, and improving their health and wellbeing. As a result, there’s an… […]

FDA clears MiRus expandable lumbar system MiRus today said it received FDA 510(k) clearance for its IO expandable lumbar interbody. Marietta, Georgia-based MiRus designed the expandable lumbar interbody to be used in PLIF and TLIF procedures. It has a low insertion profile at 4 mm, an expansion of 18 mm and a 24º lordosis. “The FDA approval of the IO expandable… […] Tyber Medical’s anatomical plating system wins FDA clearance Tyber Medical today said it received FDA 510(k) clearance for its expanded line of anatomical plating system. The Bethlehem, Pennsylvania-based Tyber Medical added mini-frag/small bone, long bone fracture and ankle fracture/fusion plates to its offering following the FDA clearance. The company designed the system to address the stabilization of fractures, osteotomies, joint fusions, non-unions and… […] Intelivation Technologies wins FDA approval for pedicle screw system Intelivation Technologies today announced that it has received FDA 510(k) clearance for its Golden Isles pedicle screw system. The Saint Simons Island, Georgia-based company designed the Golden Isles system to provide immobilization and stabilization of spinal segments in skeletally mature patients to treat the lumbar and sacral spine. It is intended for use in posterior,… […] Jury selection for Elizabeth Holmes fraud trial begins today Jury selection for ex-Theranos CEO Elizabeth Holmes’ federal fraud trial is set to begin today in U.S. District Court in San Jose, California. Holmes faces 10 counts of wire fraud and two counts of conspiracy to commit wire fraud over allegations that she knowingly misled investors by claiming Theranos technology could revolutionize blood testing. She… […] Connected workers are key to meeting medical device manufacturing demands Here’s how medical device manufacturers can navigate the “year of the connected worker.” Louis Columbus, Delmiaworks Perhaps the only thing that medical device companies and contract manufacturers can predict for 2021 will be continued unpredictability across supply chains, market demand, sales forecasts, and skilled workers’ availability. In the United States, elective surgeries are on the… […] Abbott touts Amplatzer Amulet results in head-to-head trial with Boston Scientific’s Watchman Abbott (NYSE:ABT) is claiming a big win for its Amplatzer Amulet device in a head-to-head trial with Boston Scientific’s (NYSE:BSX) Watchman. Late-breaking data presented at the European Society of Cardiology Congress and simultaneously published in Circulation support the FDA’s recent approval for the Amplatzer Amulet, Abbott said in a news release. The Amplatzer Amulet Left Atrial Appendage (LAA) Occluder is a… […] 3 questions medical device manufacturers should ask before ISO 10993-17 updates The upcoming publication of ISO 10993-17 will support the latest ISO 10993 expectations already in place. Gain insights into what this standard will mean to the evaluation process and how to prepare in advance. Sherry Parker, WuXi AppTec Medical Device Testing Following ISO 10993-1, the lens of medical device biological safety evaluation changed to a… […] Does your human factors drive design, or does your design drive human factors? A solid commitment to human factors in the design process can be critical to a medical device’s success. MaryBeth Privitera, HS Design, a SteriPack company In some early education circles, there is a philosophy that one can learn from testing. If you want a child to know vocabulary words, you can have them briefly study,… […] MicroCare acquires Certol International MicroCare has acquired Certol International, a Denver-based manufacturer of specialty cleaning and disinfecting products. New Britain, Connecticut-based MicroCare said in a news release that the acquisition aligns with its strategic goals and priorities to fuel growth by delivering innovative, value-added solutions and services to the global critical cleaning industry. Certol’s leading product and development initiatives… […] Quest Industrial launches new pallet-packing Box Bot The maker of a system that robotically packs pallets for tractor-trailer shipping has released a simpler version to appeal to a wider range of manufacturers. Quest Industrial says its standardized Box Bot QB300 has the same features and benefits as the original Box Bot, but is built for manufacturers that don’t need much additional customization.… […]