The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format. The agency issued two proposed rules today-one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting.
From Medical Design & Outsourcing
- Steris plans to build a new medical device testing facilitySteris (NYSE: STE) plans to build a new packaging and microbiological testing facility for medical devices in Leipzig, Germany. The facility will offer packaging testing services such as accelerated and real-time aging, transportation and integrity testing. The new location will also offer microbiological testing in collaboration with the medical device manufacturer and sterilizer’s laboratory in… […]
- 10 medical device startups you need to knowSome of the most interesting medical device startups of 2022 are advancing a wide range of innovative medtech: robotics, catheter-delivered brain-computer interfaces and more. The editors here at Medical Design & Outsourcing and MassDevice are writing about medical device startups all the time. But there are some device companies starting out that have technologies that… […]
- Steris stock downgraded as analysts expect lawyers to seek more ethylene oxide lawsuitsSteris (NYSE: STE) stock was downgraded today by Needham from buy to hold following the $363 million jury verdict against its primary competitor, Sterigenics, over ethylene oxide (EtO) emissions. Needham analysts said they expect attorneys to target communities near EtO facilities with ads to find people willing to file more lawsuits against sterilization plant operators… […]
- Researchers develop at-home device to track Parkinson’s progressionResearchers at MIT and the University of Rochester Medical Center have developed a device to monitor a Parkinson’s patient at home. Collecting data at home could help provide a less subjective measurement than evaluations at the doctor’s office, which can be affected by outside factors. The technology could also help pharmaceutical and biotech companies developing… […]
- Micro Mold renovates for new 5-axis milling centerPrecision mold maker Micro Mold has renovated in Erie, Pennsylvania, to make room for its new Yasda YMC650 high-speed 5-axis milling center and 3R Workpartner automation cell. The new equipment will be used for electrode manufacturing and finishing hard mill applications. The milling machine is accurate to 1 micron for high-volume, ultra-precision tooling work, the… […]
- September 2022 Issue: The Medtech Big 100 is bigger than everMedtech sales reach a record high as R&D spend and employee counts climb Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future Autotransfusion device maker ships units to Ukraine How IP protection is enabling robotic surgery innovation Connected device design for the real world: Managing the development process FDA details plans to expand… […]
- How NeuroOne and Zimmer Biomet will partner on robotic brain surgeryNeuroOne (NASDAQ: NMTC) is preparing its depth electrode technology for commercialization through Zimmer Biomet (NYSE: ZBH) while waiting for FDA feedback on its latest submission. NeuroOne’s Evo stereoelectroencephalography (sEEG) device won FDA 510(k) clearance in September 2021 for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain. That clearance was… […]
- Trelleborg to show off advanced polymer tech at MD&M MinneapolisTrelleborg Healthcare & Medical will exhibit advanced polymer technologies for medical applications at MD&M Minneapolis, which runs Nov. 2–3, 2022. The Sweden-based engineering polymer giant, which has operations in 50 companies, has newly acquired, advanced capabilities in thermoplastic injection molding. The new injection molding capabilities come from its purchase of Menomonie, Wisconsin–based EirMed earlier this… […]
- Millstone Medical Outsourcing expands cleanroom facilityMillstone Medical Outsourcing said today that it has broken ground on a 5,000-square-foot cleanroom facility expansion at its Fall River, Massachusetts headquarters. The project is Millstone’s third cleanroom expansion. The additional Class 10,000/ISO7-rated cleanroom space is for medical device packaging operations. It will bring the company’s total cleanroom footprint to 20,000 square feet. Responding to… […]
- Johnson & Johnson launches Bay Area science and technology campusJohnson & Johnson (NYSE:JNJ) has opened an almost 200,000 ft2 science and technology campus in the San Francisco Bay Area. The new facility more than doubles the presence of the company in the Bay Area, which has been a hub for life sciences innovation for decades. Up to 400 employees will work at the facility. “This… […]
- VitalPath opens new Design Center in MinnesotaVitalPath announced today that it recently opened a new Design Center in the Minneapolis suburb of New Hope. The Minnesota-based company manufactures custom, highly complex catheter solutions for major medical device companies. It says the new Design Center brings its entire design and prototyping capabilities under one roof in order to accelerate time to market.… […]
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