The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
FDA warns of device shortages again due to sterilization plant closures
The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third. Potentially affected surgical kits include those used in emergency Caesarean sections and […]
Report: Imaging industry put $9m into pushing 3D mammograms despite lack of evidence
Companies that make 3D mammography equipment have spent millions on marketing the devices, even though scientific evidence of their superiority to traditional mammography is lacking, according to a new report. The report by Kaiser Health News says that Hologic (NSDQ:HOLX), GE Healthcare (NYSE:GE), Siemens Healthineers and Fujifilm (TSE:4901) have paid doctors and teaching hospitals a collective $9.2 […]
GE Healthcare to market Theragnostics’ new PET/CT imaging agent for prostate cancer
GE Healthcare (NYSE:GE) said today that it entered into a global commercial partnership with Theragnostics for its prostate-specific membrane antigen PET/CT imaging agent. The agreement stipulates that Theragnostics is to lead the development of the GalliProst diagnostic tracer, while GE Healthcare is slated to lead pre-approval commercial preparations, plus all commercial and distribution activities after […]
Australia suspends sales of certain textured breast implants
Australian health officials have suspended sales of some textured breast implants for six months and recalled models of those implants already distributed due to concerns about an uncommon form of lymphoma. The Australian Therapeutic Goods Administration (TGA) temporarily halted import, export and supply of eight models of breast implants following reports of about 100 cases […]
Body Vision Medical raises $20m for lung diagnostic tech
Body Vision Medical said today that it closed $20 million in Series C funding, which is earmarked for its LungVision 2.0 platform. The Ramat Ha Sharon, Israel-based company said the money will be used to streamline commercialization and manufacturing activities for the LungVision 2.0. LungVision 2.0, which was cleared by the FDA in May, features […]
Varian wins tariff exclusion for radiotherapy components
Varian Medical (NYSE:VAR) today said the U.S. Trade Representative granted exclusion of its radiotherapy system components from China in the latest tariffs. Palo Alto, Calif.-based Varian said components sourced from China for its linear accelerators manufactured in the U.S. were granted exemption from Section 301 of the tariffs. The exemption took place on Sept. 20. “We […]
Merit Medical closes $50m BrightWater buyout
BrightWater Medical said today that it completed the sale of the organization to Merit Medical (NSDQ:MMSI), three months after Merit made its $50 million offer. In June, Merit valued the acquisition at $35 million upfront with a further $15 million in potential payments contingent upon CE Mark approval and meeting future sales targets. Temecula, Calif.-based BrightWater’s […]
Signet Medical licenses melanoma sniffer tech
Signet Medical Solutions (OTC:SIGN) said today that it will license all rights to its non-invasive, vapor analysis system for detecting melanoma. The technology is designed to operate in real time, using vapor samples for painless diagnoses without time delays, according to parent company Signet International Holdings (Palm Beach, Fla.). Melanoma, along with other cancers, gives […]
Varian backs Oncora, launches Ethos radiotherapy device
Varian Medical (NYSE:VAR) said last week that it invested an unspecified amount in Oncora Medical and launched its Ethos artificial intelligence radiotherapy device. Philadelphia-based Oncora makes software used to plan radiotherapy procedures. Palo Alto, Calif.-based Varian said the partnership with Oncora is aimed at accelerating its software development for radiation oncology. “We envision a world where all […]
IceCure Medical inks distro deal with Terumo for Japan, Singapore
IceCure Medical said today that it has signed Terumo (OTC:TRUMY;TYO:4543) as the exclusive distributor of its tumor-freezing technology in Japan and Singapore. Terumo will pay IceCure $2 million for the distro rights if IceCure obtains the appropriate regulatory approvals for its ProSense cryoablation device, designed to treat malignant breast tumors without surgery. This will include […]
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