2023年1月20日

FDA今天宣布，緊急使用授權下的某些COVID-19診斷測試現在具有更長的保質期。雅培、Maxim Biomedical和iHealth Labs的診斷產品均獲得了有效期的延長。雅培BinaxNow COVID-19抗原自檢產品現在的保質期為22個月。此前，這種流行的測試隻有15個月的保質期。Maxim Biomedical的ClearDetect COVID-19抗原家用測試最初獲得授權，保質期為8個月。FDA宣布將該測試的保質期延長至12個月。iHealth Labs COVID-19抗原快速檢測從12個月延長至15個月。FDA在一份通知中表示:“這些測試的有效期已被延長，以反映更長的保質期。”該機構的延期是基於製造商提供的額外數據。這些數據證明了測試的耐久性和預期的準確性。 Philips’ significant CPAPs recall has placed a spotlight on the seriousness of communications gaps involving home-use medical devices. The nonprofit safety organization ECRI recently released its annual Top 10 Health Technology Hazards report. The report said the No. 1 health technology safety issue for 2023 involves communications over medical devices in the home. The trend… […] Outset Medical CEO Leslie Trigg and the beginner’s mindset Move over baby boomers, former Medtronic CEO Bill George says The biggest medtech personnel moves in 2022 5 tips from medtech leaders for the next generation How this medtech molder is navigating challenging times Assurea’s co-founder is on a mission to elevate women in pharma Why… […] Beckman Coulter Life Sciences announced today that it completed phase one of its new research and development hub in Colorado. The company’s $10 million complex sits in the Axis 25 Development at 4510 Byrd Drive in Loveland, Colorado. Through the expansion, Beckman Coulter expects to create 85 new high-paying jobs in Loveland in the coming… […] Realize Medical announced today that it received FDA 510(k) clearance for its Elucis virtual reality (VR) software for surgical planning. The Ottawa, Canada-based startup designed Elucis to enable the quick creation, understanding and sharing of complex anatomy. Medical professionals can do so with CTs and MRIs in an immersive 3D environment. Elucis lets users connect… […] Intricon today said it has hired longtime Medtronic director Tim Deraney as VP of global operations. Deraney replaces Dennis Gonsior, who retired after 41 years with Intricon. Deraney was most recently senior director of global contract manufacturing and OEM at Medtronic, according to his LinkedIn profile. He’s held other leadership positions in engineering, manufacturing and… […] Medtech industry analysts at Needham & Co. who are tracking Google search trends for 20 elective medical procedures say interest is near or above pre-pandemic levels. “We believe that Google Trends data may provide insight into the level of consumer interest in elective procedures,” analysts Mike Matson, David Saxon and Joseph Conway wrote in a… […] Scientists aiming to learn about how COVID-19 affects the body long-term have developed a machine learning tool to help. Researchers across the country developed the software platform, led by Justin Reese (Berkeley Lab) and Peter Robinson (Jackson Lab). It analyzes entries in electronic health records (EHRs) to find symptoms common in people diagnosed with long… […] Intricon today said it has launched a new Biosensors Center of Excellence focused exclusively on medical devices. The St. Paul, Minnesota-based medical device developer and manufacturer said the center of excellence combines Intricon’s biosensor device expertise and capabilities into a vertically integrated business unit focused solely on bringing biosensor medical devices to market. “OEMs and… […] Ilika and Cirtec Medical say they have entered into a manufacturing and commercialization partnership for Ilika’s Stereax line of miniature, solid-state batteries. The companies’ memorandum of understanding outlines the transfer of Stereax millimeter-scale battery manufacturing to Cirtec’s production facility in Lowell, Massachusetts. RELATED: How tiny solid-state batteries enable smaller implants that recharge faster The deal… […] The University of South Florida received the Patents for Humanity award for its patent of a 3D-printed nasopharyngeal swab. Developers created the swab in the early part of the COVID-19 pandemic to solve production disruptions during a time of critical need for COVID-19 testing. The U.S. Patent and Trademark Office (USPTO) awarded USF with the… […]