Varian Medical (NYSE:VAR) said today it won FDA 510(k) clearance for its Calypso anchored beacon transponder designed for use with its TruBeam, Edge and Clinac C-series medical linear accelerators. The Calypso system and the anchored beacon transponder are designed to detect tumor movement to aid in the delivery of lung stereotactic body radiotherapy with more precision, […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
FDA approves IDE trial for Urotronic’s drug-coated balloon
Minneapolis-based Urotronic said this week that the FDA approved an investigational device exemption trial for its Optilume drug-coated balloon catheter, which is designed to treat urethral strictures in men. The 200-patient pivotal trial is slated to start enrolling participants immediately. Get the full story at our sister site, Drug Delivery Business News.
FDA approves Angel Medical System’s AngelMed Guardian cardiac monitor
The FDA this week approved Angel Medical Systems AngelMed Guardian implantable cardiac monitor system after the device had previously been rejected unanimously by an FDA advisory panel in 2016. The initial rejection came after the Tinton Falls, N.J.-based company presented partial data from its pivotal trial of the device in after having pulled the plug […]
Curetis launches diagnostic cartridge for urinary tract infection
Curetis said today that it won CE-IVD marking for its Unyvero cartridge designed to diagnose severe urinary tract infections. The cartridge covers 103 diagnostic targets and can detect 88 pathogens, according to Curetis, including a multi-drug-resistant pathogenic fungus that is of particular concern to hospitalized patients with compromised immune systems. Unyvero UTI can also detect 15 […]
FDA OKs Opus breast implant line from Sientra
The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants. The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016. Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when […]
Qiagen wins FDA nod for point-of-care PartoSure test
Qiagen (NYSE:QGEN) today touted the FDA’s approval of its PartoSure diagnostic test, designed to assess the risk of spontaneous preterm birth in patients with symptoms of preterm labor. The non-invasive strip test detects placental alpha microglobulin-1 and can provide results in less than five minutes, according to Germany-based Qiagen. Get the full story at our sister […]
Arthrosurface wins FDA nod for OVOMotion shoulder arthroplasty system
Arthrosurface said yesterday it won FDA 510(k) clearance for its OVOMotion shoulder arthroplasty system. The Franklin, Mass.-based company said the newly cleared stemless total shoulder system is designed to minimize bone removal specifically for patients with painful or severely disabled shoulder joints from arthritis, traumatic events or avascular necrosis. “This truly is a revolutionary stemless […]
FDA warns against endoscope connectors
The FDA yesterday warned healthcare providers against using endoscope connectors in more than one patient without reprocessing, saying it hasn’t seen any acceptable tests demonstrating their safety. The federal safety watchdog said the connectors, which are used in more than one patient for gastrointestinal endoscopies over the course of 24 hours, connect the endoscope to […]
HeartStitch wins CE Mark for CoAp Pro mitral valve repair device
HeartStitch said today it won CE Mark approval in the European Union for its CoAp Pro device designed for mitral valve remodeling and repair. The Fountain Valley, Calif.-based company said its CoAp Pro device is designed to allow physicians to remodel mitral valve leaflets to re-establish proper coaptation. “I am especially pleased to see HeartStitch receive […]
Siemens wins more FDA nods for Somatom CT platform, clearing go.All and go.Top scanners
Siemens (NYSE:SI) Healthineers said today it won another FDA nod for its Somatom portfolio, this time for its Somatom go.All and go.Top computed tomography systems. The company said its go. CT platform devices are controlled via tablet and remote, and that its go.ALL CT scanner features a 0.33-second rotation time, 75 kW generator and 64-slice capabilities. The […]
Cantel Medical wins FDA nod for Advantage Plus endoscope reprocessor
Cantel Medical (NYSE:CMD) said today it won FDA 510(k) clearance for its Advantage Plus pass-thru automated endoscope reprocessor, making it the first AER available in the US, the company claims. The newly cleared device is designed for the high-level disinfection of commonly used endoscopes, including duodenoscopes, the Little Falls, N.J.-based company said. “We strive to deliver real life […]