The FDA has granted emergency use authorization for the first COVID-19 antibody test that allows patients to collect blood at home. The Symbiotica COVID-19 self-collected antibody test system enables adults to obtain a fingerstick dried blood sample at home from themselves or from a child age 5 or older and send it to a Symbiotica laboratory for […]
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FDA clears Philips’ Smart CT application software
Royal Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its Philips SmartCT application software. Amsterdam-based Philips’ SmartCT software is a component of the company’s Azurion image-guided therapy system for diagnosis, therapy planning, treatment and follow-up for interventional radiology procedures. SmartCT helps to enhance clinical confidence, smooth the workflow and increase productivity through […]
Emergent has reportedly had serious problems at Baltimore vaccine plant
Emergent BioSolutions was not prepared to take on the mammoth task of churning out millions of COVID-19 vaccine doses to support U.S. efforts to end the pandemic, according to a report published today in The New York Times. Emergent was ill-equipped despite a $163 million federal contract to prepare the facility for high-volume production, according to the Times investigation, […]
MIT, Indian researchers grow tiny brains in 3D-printed bioreactor
Scientists in Cambridge, Mass. and Chennai, India, are touting self-organizing brain tissue growth in a 3D-printed system. Published results in Biomicrofluidics highlight the work of the Massachusetts Institute of Technology (MIT) and Indian Institute of Technology Madras scientists, who have grown small amounts of the self-organizing brain tissue, known as organoids, in a tiny 3D-printed system that […]
MTF Biologics says FDA used old data to malign its surgical mesh
A surgical mesh company claims the FDA improperly called one of its products’ safety into question. The agency said last week that two surgical mesh brands used off-label in breast reconstruction surgery have had “significantly higher major complication rates.” It named FlexHD by MTF Biologics and AlloMax by BD as having had higher rates of explantation, reoperations and infections two years […]
Abbott Xience stent gains expanded CE mark
Abbott (NYSE:ABT) announced today that its Xience stent received CE mark approval for a shorter duration of dual anti-platelet therapy (DAPT). The European approval for the stent allows for the DAPT to go as short as 28 days, the shortest indication available in the world for patients with high bleeding risk (HBR), according to a news […]
Erbe Elektromedizin to acquire Maxer Endoscopy
Erbe Elektromedizin announced today that it is set to acquire Maxer Endoscopy for an undisclosed amount. Teubingen, Germany–based Erbe Elektromedizin develops, manufactures and distributes surgical instruments and devices in almost all specialist areas. Combined with other Erbe technologies, the surgical instruments are based on electrosurgery. Tuttlingen, Germany–based Maxer specializes in a wide range of endoscopic […]
Nevro touts data supporting use of Senza system to treat diabetic neuropathy pain
Nevro (NYSE:NVRO) today touted results from a trial of its Senza system for treating painful diabetic neuropathy (PDN)-related chronic pain. Redwood City, Calif.-based Nevro, which published the results of the SENZA-PDN trial in JAMA Neurology, said in a news release that, if approved, the Senza spinal cord stimulation (SCS) system would be the first FDA-approved […]
Second Sight, Pixium Vision merger plans are over
Second Sight Medical notified Pixium that it decided to unilaterally terminate a memorandum of understanding (MOU) ahead of a planned merger. In a news release, Pixium said the $27.9 million private placement recently announced and closed by Second Sight was “not only explicitly prohibited under the terms of the [MOU] entered into by the companies […]
UCLA prof: Racial bias in medical devices based in physics
The laws of physics may be making medical devices biased against people of color, according to a UCLA engineering professor. Achuta Kadambi, an assistant professor at the UCLA Samueli School of Engineering, published a column in the journal Science about how dataset representation is not the only factor leading to bias in medtech. Kadambi described how the […]
Feds put J&J in charge of vaccine production at Emergent plant
Johnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility. The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines. Get the full story at our sister site, […]