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Home » Topics » Medical devices » Artificial organ

Artificial organ
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South Korean flag on building

Kangstem completes research, takes next steps for South Korea’s first artificial liver

Nov. 3, 2020
By Gina Lee
HONG KONG – Kangstem Biotech Co. Ltd. has completed research on South Korea’s first artificial liver and is taking the next steps towards the device’s clinical trials. The research outcome was published in a paper authored by Kyung-Sun Kang, CEO at Kangstem, and his team titled ‘Development of highly functional bioengineered human liver with perfusable vasculature’ in Biomaterials.
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South Korean flag on building

Kangstem completes research, takes next steps for South Korea’s first artificial liver

Oct. 28, 2020
By Gina Lee
HONG KONG – Kangstem Biotech Co. Ltd. has completed research on South Korea’s first artificial liver and is taking the next steps towards the device’s clinical trials.
Read More
Colorful illustration of the heart

CMS draws heat for proposal to eliminate national coverage for artificial hearts

Sep. 25, 2020
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) recently proposed some changes to national coverage policies for left ventricular assist devices (LVADs) and artificial hearts, the latter of which would no longer be covered under a national coverage determination. The proposal to allow Medicare administrative contractors (MAC) to make coverage decisions for artificial hearts on a case-by-case basis clanged across both industry and medical societies, which cited data collection problems and inequalities in access as reasons the existing coverage policy should remain in place.
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Artificial pancreas prevents hypoglycemia in type 1 diabetes

Sep. 4, 2020
By Annette Boyle
Spanish researchers developed a new artificial pancreas system that maintained blood glucose levels in individuals with type 1 diabetes mellitus (T1D) during and following heavy physical exercise. Results of the small study were published in the Endocrine Society’s Journal of Endocrinology & Metabolism.
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3D heart in chest

CMS proposes to drop artificial heart coverage memo, overhaul coverage mandates for VADs

Aug. 12, 2020
By Mark McCarty
In a single draft coverage memo, the U.S. Centers for Medicare and Medicaid Services (CMS) proposed to eliminate national coverage for artificial hearts and to provide coverage of ventricular assist devices (VADs) coverage for those in need of short-term ventricular support. Coverage of artificial hearts would thus revert to Medicare administrative contractors, while the change in VAD coverage would resolve a long-running dispute between cardiologists and the agency.
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Carmat’s artificial heart product image
Bioprosthetic artificial heart

Carmat obtains nod for reimbursement for its total artificial heart under innovation scheme in France

May 29, 2020
By Bernard Banga
PARIS – Carmat SA, which is based in Vélizy Villacoublay, France, reported the first implantation of its bioprosthetic artificial heart at the Heart Center of the Rigshospitalet in Copenhagen, Denmark.
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4-21-Lambdavision-retina.png

Artificial retina program wins $5M NASA award

April 21, 2020
By Meg Bryant
Farmington, Conn.-based biotech startup Lambdavision Inc. is preparing to test the benefits of microgravity in producing its protein-based artificial retina, thanks to a $5 million, three-year award from the National Aeronautics and Space Administration (NASA). The first-of-a-kind treatment aims to restore vision to people who have lost all or much of their sight due to advanced retinitis pigmentosa (RP).
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4-10-Diabeloop.png

Eyeing FDA clearance, Diabeloop kicks off real-world study

April 10, 2020
By Bernard Banga
PARIS – Diabeloop SAS, of Grenoble, France, has launched a real-world study of its automated insulin delivery DBLG1 system, incorporating the Dana-I pump from Sooil Development Co. Ltd., of Seoul, South Korea.
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3-16-Beta-Air-pancreas.png

Beta-O2 Technologies to begin human trials on new artificial pancreas

March 16, 2020
By Annette Boyle
Beta-O2 Technologies Ltd. plans to enroll its first patients in clinical trials for its second-generation bio-artificial pancreas, ßAir, in the coming months. The small, implantable titanium device has separate components that hold pancreatic cells and a rechargeable oxygen tank. Beta-O2 is based in Rosh-Haayin, Israel.
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Approved stamp

Carmat wins OK from the FDA for its U.S. clinical feasibility study

Feb. 10, 2020
By Bernard Banga
PARIS – Carmat SA, from Vélizy-Villacoublay, France, has obtained full FDA approval for its investigational device exemption application (IDE). The company is now able to initiate a U.S. early feasibility study (EFS) of its total artificial heart. “This full approval to initiate a U.S. study confirms the FDA’s confidence in our ability to conduct a feasibility study of the first bio-prosthetic artificial heart in the United States,” Stéphane Piat, CEO of Carmat, told BioWorld.
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