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BioWorld - Thursday, July 16, 2026
Home » Topics » FDA, Medical technology

FDA, Medical technology
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4-28-Aytu-cedars-sinai-main-building.png

UV light, respiratory catheter for COVID-19 from Cedars-Sinai seeking emergency use

April 28, 2020
By Stacy Lawrence
Ultraviolet (UV) light has a long-standing track record in use as an antimicrobial. But the primary limitation to using UV light in relation to the human body is that it can also potentially damage its cells. A group of researchers at the Cedars-Sinai Medical Center in Los Angeles, Calif., known as the Medically Associated Science and Technology (MAST) team, is now researching safe UV technology for use in COVID-19 treatment.
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Alung-hemolung-system.png

FDA OKs emergency use of Alung’s Hemolung for COVID-19 patients

April 24, 2020
By Meg Bryant
Pittsburgh-based Alung Technologies Inc. has received emergency use authorization from the U.S. FDA for its Hemolung Respiratory Assist System (RAS) to treat lung failure caused by COVID-19. The technology could help to ease demand for ventilators, which have been in short supply in coronavirus hot spots, and provide an alternative for patients who can’t tolerate mechanical ventilation.
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Man clutching heart

Viscardia gains FDA breakthrough designation for diaphragm implant to treat heart failure

April 24, 2020
By Stacy Lawrence
Portland, Ore.-based startup Viscardia Inc. has received breakthrough device designation from the FDA for its implantable Visone system to treat moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony. The minimally invasive implant works by stimulating a specific portion of the diaphragm.
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Incyte wins FDA approval for first targeted cholangiocarcinoma treatment

April 21, 2020
By Michael Fitzhugh
With a coronavirus task force briefing unfolding at the White House late on April 17, an FDA eager to show its ongoing commitment to tackling other disease amid the pandemic, granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma.
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Coronavirus vs U.S. wrecking balls

Administration’s outpatient-first policy should aid cardiovascular, orthopedic implants

April 21, 2020
By Mark McCarty
The Trump administration has proposed a policy to gradually reopen the U.S. for business, part of which is to allow a resumption of elective procedures and treatments in outpatient settings. While patients with urgent medical needs presumably are being treated already, the policy would seem to promise a boost in volumes for certain devices, such as coronary artery stents, knee implants and transcatheter aortic valve replacement (TAVR) devices, all of which enjoy at least limited Medicare coverage for outpatient use.
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Vent Multiplexor’s ventilator-sharing device wins FDA nod for emergency use

April 20, 2020
By Meg Bryant
The U.S. FDA has granted emergency use authorization (EUA) to New Haven, Conn., startup Vent Multiplexor LLC for its emergency rescue co-ventilation device. Developed in collaboration with Yale New Haven Hospital, the Vent Multiplexor enables individualized mechanical ventilation of two adults on a single ventilator – lessening demand for more critical care machines in the ongoing COVID-19 outbreak.
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Ortho-vitros-antibody-blood-test.png

Ortho Clinical Diagnostics scores win with total antibody test for COVID-19

April 20, 2020
By Liz Hollis
The COVID-19 pandemic has moved rapidly over the past few weeks, and Ortho Clinical Diagnostics Inc. is doing its part to help during the crisis. To that end, the Raritan, N.J.-based company has worked to successfully secure an emergency use authorization (EUA) for its total antibody assay for COVID-19, the Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and calibrators.
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Microscope image of SARS-CoV-2

Osang becomes first Korean company to win FDA emergency authorization

April 20, 2020
By Gina Lee
HONG KONG – South Korea’s Osang Healthcare Co. Ltd. became the first Korean company to receive the U.S. FDA’s emergency use authorization (EUA) for its COVID-19 test kit. In a letter dated April 18, 2020, the FDA informed Osang of its authorization for the company’s Genefinder COVID-19 Plus Realamp Kit.
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Synapse gains EUA from FDA to stimulate the diaphragm of ventilated patients

April 16, 2020
By Stacy Lawrence
Case Western Reserve University spinout Synapse Biomedical Inc. has received emergency use authorization from the U.S. FDA for its Transaeris diaphragm pacing system (DPS) device to prevent and treat ventilator-induced diaphragm dysfunction (VIDD).
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Respiratory infection

FDA’s Stenzel: EUA for COVID-19 home collection sample kit will happen ‘very soon’

April 15, 2020
By Mark McCarty
An April 15 U.S. FDA stakeholder call revisited several themes of interest in connection with diagnostics for the COVID-19 pandemic. However, Tim Stenzel, director of the agency’s Office of In Vitro Diagnostics and Radiological Health, said that while the agency has not yet authorized a home sample collection kit, “we do think it’s going to happen very soon.”
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