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Varian wins FDA nod for Calypso anchored beacon transponder for SBRT therapy

April 20, 2018 By Fink Densford Leave a Comment

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, […]

Filed Under: 510(k), Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Varian Medical Systems

FDA approves Angel Medical System’s AngelMed Guardian cardiac monitor

April 20, 2018 By Fink Densford Leave a Comment

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Patient Monitoring, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: Angel Medical Systems Inc.

Curetis launches diagnostic cartridge for urinary tract infection

April 20, 2018 By Sarah Faulkner Leave a Comment

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 […]

Filed Under: Diagnostics, Pharmaceuticals, Regulatory/Compliance Tagged With: curetis

FDA OKs Opus breast implant line from Sientra

April 20, 2018 By Brad Perriello Leave a Comment

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 […]

Filed Under: Cosmetic/Aesthetic, Food & Drug Administration (FDA), Regulatory/Compliance, Women's Health Tagged With: Sientra

Qiagen wins FDA nod for point-of-care PartoSure test

April 20, 2018 By Sarah Faulkner Leave a Comment

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 […]

Filed Under: Diagnostics, Food & Drug Administration (FDA), Regulatory/Compliance, Wall Street Beat, Women's Health Tagged With: Qiagen N.V.

Arthrosurface wins FDA nod for OVOMotion shoulder arthroplasty system

April 19, 2018 By Fink Densford Leave a Comment

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance Tagged With: Arthrosurface

HeartStitch wins CE Mark for CoAp Pro mitral valve repair device

April 19, 2018 By Fink Densford Leave a Comment

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 […]

Filed Under: Cardiovascular, Regulatory/Compliance Tagged With: HeartStitch

Siemens wins more FDA nods for Somatom CT platform, clearing go.All and go.Top scanners

April 18, 2018 By Fink Densford Leave a Comment

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 […]

Filed Under: Food & Drug Administration (FDA), Imaging, Regulatory/Compliance Tagged With: Siemens Healthineers

Cantel Medical wins FDA nod for Advantage Plus endoscope reprocessor

April 18, 2018 By Fink Densford Leave a Comment

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 […]

Filed Under: 510(k), Endoscopic / Arthroscopic, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Cantel Medical Corp.

LivaNova wins CE Mark for SenTiva VNS epilepsy treatment

April 17, 2018 By Fink Densford Leave a Comment

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 […]

Filed Under: Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: LivaNova

Report: China to restructure its FDA

April 17, 2018 By Fink Densford Leave a Comment

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 […]

Filed Under: Regulatory/Compliance Tagged With: China Food & Drug Administration (CFDA)

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