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 […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
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 […]
FDA releases new action plan looking to improve device cybersecurity, streamline approvals
FDA Commissioner Scott Gottlieb today released a statement laying out the federal watchdog’s plans for improving medical device regulation, including plans to improve cybersecurity and monitor the total product life cycles of devices. The announcement came as part of the FDA’s newly released “Medical Device Safety Action Plan”. The plan focuses on five key areas, […]
LivaNova wins CE Mark for SenTiva VNS epilepsy treatment
LivaNova (NSDQ:LIVN) said today it won CE Mark in the European Union for its Vagus Nerve Stimulation Therapy system, now indicated for treating patients with drug-resistant epilepsy. The VNS Therapy system is composed of the London-based company’s SenTiva implantable generator and a next-gen VNS therapy programming system. LivaNova touted the SenTiva generator as the smallest and […]
Report: China to restructure its FDA
China is looking to restructure its Food and Drug Administration, according to a new report from the Regulatory Affairs Professionals Society. With the reorganization, the CFDA will cease being a standalone department and will become part of the country’s National Market Supervision Association, according to the report. The CFDA group is slated to add an […]