Nearly two dozen people who have lived in the Augusta, Ga. area are suing Cardinal Health subsidiary Kendall Patient Recovery U.S. over ethylene oxide emissions from a medical device sterilization plant in the city. The people suing KPR U.S. in U.S. District Court in Southern Georgia lived and worked within miles of the Augusta facility […]
The FDA announced as part of its annual budget proposal that it will seek $21.6 million for a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP). Funding from the RSCSPP for the Center for Devices and Radiological Health (CDRH) will provide — the FDA says, for the first time — resources to establish a […]
Xeris Pharmaceuticals (NSDQ:XERS) announced today that it entered into an exclusive agreement with Tetris Pharma to commercialize Ogluo. Chicago-based Xeris designed Ogluo (Gvoke PFS and Gvoke HypoPen in the U.S.) to be a ready-to-use, pre-mixed, pre-measured glucagon injection for treating severe hypoglycemia in adults, adolescents and children two years of age and older with diabetes mellitus. Get the […]
Nephros (Nasdaq: NEPH) announced today that it has acquired almost all of the assets of Rockville, Md.–based GenArraytion. The financial terms of the deal were not disclosed. Nephros officials said the purchase will give their company access to a host of GenArraytion proprietary assays, multiplexing technology, and selection methods for detecting waterborne pathogens and other […]
In this week’s DeviceTalks Weekly Podcast, we talk with Dr. James Min, the founder and CEO of Cleerly Health, a potentially disruptive diagnostics company that raised $43 million last week. Min explains how Cleerly Health formed from his work at Weill Cornell Medicine. But, more importantly, for entrepreneurs and executives, he walks listeners through the […]
Private equity firm Summit Partners has acquired Ximedica, Quartesian and Boston Healthcare Associates — rolling them into a new medtech service company called Veranex. In its inaugural news release on June 16, the new Raleigh, N.C.- based company touted itself as the first concept-to-commercialization global service provider — with capabilities including design and engineering, regulatory, […]
Medtech contract manufacturers such as Minnetronix often avoid making their own devices. But CEO Jeremy Maniak had a different idea. Minnetronix Medical (St. Paul, Minn.) is closing on its quarter-century mark, and Jeremy Maniak has been with the company more than half of that time. Promoted into the corner office in early 2020, he has […]
Avania today said it has acquired medical device clinical research outfit IMARC for an undisclosed amount. Strongsville, Ohio–based IMARC is a full-service clinical research oversight company that offers monitoring, auditing, safety, data management and training. Get the full story on our sister site, Medical Design & Outsourcing.
Medical device manufacturing is flourishing in the Central American country, spurred by a host of incentives. This year is seeing a wave of expansions by medtech contract manufacturers in Costa Rica. Medtech OEMs have made the Central American company a manufacturing hub since the 1990s. Major companies operating there include Abbott, Bayer, Boston Scientific, Cardinal […]
Moderna (NSDQ:MRNA) announced today that the U.S. government purchased an additional 200 million doses of its COVID-19 vaccine. The government’s purchase agreement with Moderna also includes the option to purchase other COVID-19 vaccine candidates to come out of the company’s pipeline. Get the full story at our sister site, Pharmaceutical Processing World.
Another large amount of doses of Johnson & Johnson’s COVID-19 vaccine produced at an embattled manufacturing plant reportedly have to be thrown out. The New York Times reported that the FDA told J&J that about 60 million doses of the single-dose vaccine produced at Emergent BioSolutions’ Baltimore plant can’t be used because of possible contamination. Get the full […]