https://www.bioworld.com/rss en-us Bioprosthetic heart maker Carmat SA shares collapsed on June 23, reaching €0.28 on the Paris Stock Exchange after the company announced it would run out of cash by the end of the month without immediate financial support. http://www.bioworld.com/articles/721207 Mon, 23 Jun 2025 12:00:00 -0400 https://www.bioworld.com/articles/721207-hearts-break-as-carmat-faces-insolvency Person holding Carmat's bio-prosthetic artificial heart Aeson, Carmat’s bio-prosthetic self-regulating artificial heart. Credit: Carmat SA. The U.S. FDA’s decision to grant breakthrough device designation for Bivacor Inc.’s titanium total artificial heart (TAH) sent real hearts aflutter at the Huntington, Calif.-based company’s headquarters. While the designation supports use of the TAH as a bridge to transplant for adults with biventricular or univentricular heart failure for whom current options are insufficient or unsuitable, Bivacor hopes its device will eventually serve as a long-term heart replacement. http://www.bioworld.com/articles/720628 Mon, 02 Jun 2025 12:00:00 -0400 https://www.bioworld.com/articles/720628-bivacor-pumped-by-artificial-hearts-breakthrough-designation Bivacore TAH The European Parliament (EP) has passed the Artificial Intelligence Act (AI Act), bringing the legislation one step closer to full passage into law, with passage by the European Council the only remaining hurdle. http://www.bioworld.com/articles/706236 Wed, 13 Mar 2024 12:00:00 -0400 https://www.bioworld.com/articles/706236-european-parliament-passes-artificial-intelligence-act Ribbons of digital data People who can’t verbalize their pain often end up being under medicated, and Painchek Ltd. uses artificial intelligence (AI) to identify the presence of pain even when it may not be obvious. This gives a voice to those who cannot verbalize pain, while also driving objectivity and consistency in pain assessments. http://www.bioworld.com/articles/700651 Wed, 06 Sep 2023 12:00:00 -0400 https://www.bioworld.com/articles/700651-painchek-rolls-out-first-ai-powered-pain-assessment-solution-in-north-america PainChek Painchek is the first regulatory-cleared medical device for the assessment of pain. Credit: Painchek. Artificial intelligence (AI) has been approved for use in the U.K. National Health Service (NHS) for the first time, after passing an expedited health technology assessment. http://www.bioworld.com/articles/699868 Mon, 14 Aug 2023 12:00:00 -0400 https://www.bioworld.com/articles/699868-ai-approved-for-use-in-the-uk-health-system-for-the-first-time PARIS – Defymed SAS reported the formation of the Decapes consortium, which brings together the Institute of Chemistry and Processes for Energy, Environment and Health (ICPEES) and the specialist microtechnology and biomaterials service provider for med-tech companies, Statice. This French consortium is working on a minimally invasive version of Defymed's Mailpan device, which will extend the application range for this artificial pancreas to include other chronic pathologies besides type 1 diabetes. http://www.bioworld.com/articles/512917 Mon, 01 Nov 2021 13:00:00 -0400 https://www.bioworld.com/articles/512917-defymed-to-extend-range-of-applications-for-its-bio-artificial-pancreas-to-include-cancer-hemophilia Person working on the Mailpan bio-artificial pancreas Defymed's team has developed a porous thermoplastic membrane to contain stem cells that secrete insulin. The pouch can then be placed into the peritoneal cavity. 3D Systems Inc. acquired Volumetric Biotechnologies Inc. as part of its plan to expand its organ bioprinting program. The deal entails a $45 million upfront payment with an additional $355 million linked to meeting milestones “planned between now and 2035, and aligned with key points in the development process,” Volumetric President and CEO Jeffrey Graves told BioWorld. Houston-based Volumetric has focused on building replacement organs through bioprinting and created an approach that produces complex vasculature using light-based bioprinting. BioWorld. Houston-based Volumetric has focused on building replacement organs through bioprinting and created an approach that produces complex vasculature using light-based bioprinting.]]> http://www.bioworld.com/articles/512895 Fri, 29 Oct 2021 13:00:00 -0400 https://www.bioworld.com/articles/512895-3d-systems-acquires-volumetric-for-up-to-400m-expands-organ-bioprinting-program Image of human vasculature model Human vasculature model created using Print to Perfusion process. Credit: United Therapeutics PARIS – Carmat SA has just completed a capital increase of $66.4 million to boost development of its total artificial heart. The Aeson system was awarded CE marking four months ago, as a total bridge to transplantation for patients suffering with end-stage biventricular heart failure who are not eligible for maximal medical therapy or a left ventricular assist device (LVAD), and who are likely to undergo a heart transplant within 180 days of the implantation. http://www.bioworld.com/articles/504736 Mon, 15 Mar 2021 13:00:00 -0400 https://www.bioworld.com/articles/504736-carmat-raises-664m-to-launch-its-artificial-heart-in-europe Person holds artificial heart in hands Bioprosthetic self-regulating artificial heart. Credit: Carmat SA Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second quarter of 2021. The artificial heart offers a bridge to transplant in patients with end-stage biventricular heart failure. It provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated. http://www.bioworld.com/articles/501756 Wed, 23 Dec 2020 13:00:00 -0500 https://www.bioworld.com/articles/501756-carmats-artificial-heart-receives-ce-mark Total artificial heart being manufactured Bioprosthetic self-regulating artificial heart. Credit: Carmat SA PARIS – Carmat SA has closed an $11.8 million loan in the form of a government-backed loan from a French banking syndicate. In an environment made uncertain by the COVID-19 crisis, Carmat will be able to continue its clinical development program on its total artificial heart, undisturbed. “This financing facility contributes to securing our cash position and extends our financial visibility through to the third quarter of 2021,” Stéphane Piat, CEO of Carmat, told BioWorld. BioWorld.]]> http://www.bioworld.com/articles/500606 Tue, 24 Nov 2020 13:00:00 -0500 https://www.bioworld.com/articles/500606-carmat-wins-non-dilutive-financing-of-118m-from-the-french-government Product image Bioprosthetic self-regulating artificial heart. Credit: Carmat SA Wellcome Leap has launched its first program, dedicating $50 million to help develop human tissues, organoids and full organs. The Human Organs, Physiology and Engineering (HOPE) program is looking to bring biologists and engineers together to develop both therapeutic organs as well as organs that can be used in vitro to help discover and develop new medications. http://www.bioworld.com/articles/499963 Mon, 09 Nov 2020 12:00:00 -0500 https://www.bioworld.com/articles/499963-wellcome-leap-kicks-off-its-funding-with-50m-to-develop-human-organs 3D bioprinting technology 3D bioprinting. Credit: Aspect Biosystems Ltd. 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. http://www.bioworld.com/articles/499738 Tue, 03 Nov 2020 16:18:00 -0500 https://www.bioworld.com/articles/499738-kangstem-completes-research-takes-next-steps-for-south-koreas-first-artificial-liver South Korean flag on building 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. http://www.bioworld.com/articles/499529 Wed, 28 Oct 2020 13:00:00 -0400 https://www.bioworld.com/articles/499529-kangstem-completes-research-takes-next-steps-for-south-koreas-first-artificial-liver South Korean flag on building 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. http://www.bioworld.com/articles/498228 Fri, 25 Sep 2020 13:00:00 -0400 https://www.bioworld.com/articles/498228-cms-draws-heat-for-proposal-to-eliminate-national-coverage-for-artificial-hearts Colorful illustration of the heart 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. Journal of Endocrinology & Metabolism.]]> http://www.bioworld.com/articles/497433 Fri, 04 Sep 2020 13:00:00 -0400 https://www.bioworld.com/articles/497433-artificial-pancreas-prevents-hypoglycemia-in-type-1-diabetes 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. http://www.bioworld.com/articles/496703 Wed, 12 Aug 2020 13:00:00 -0400 https://www.bioworld.com/articles/496703-cms-proposes-to-drop-artificial-heart-coverage-memo-overhaul-coverage-mandates-for-vads 3D heart in chest 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. http://www.bioworld.com/articles/435448 Fri, 29 May 2020 13:00:00 -0400 https://www.bioworld.com/articles/435448-carmat-obtains-nod-for-reimbursement-for-its-total-artificial-heart-under-innovation-scheme-in-france Carmat’s artificial heart product image Carmat’s self-regulating bioprosthetic artificial heart. Credit: Carmat SA 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). http://www.bioworld.com/articles/434567 Tue, 21 Apr 2020 13:00:00 -0400 https://www.bioworld.com/articles/434567-artificial-retina-program-wins-5m-nasa-award 4-21-Lambdavision-retina.png Artificial retina. Credit: Lambdavision Inc. 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. http://www.bioworld.com/articles/434342 Fri, 10 Apr 2020 13:00:00 -0400 https://www.bioworld.com/articles/434342-eyeing-fda-clearance-diabeloop-kicks-off-real-world-study 4-10-Diabeloop.png The DBLG1 system includes a smartphone, a continuous glucose monitor and a micro-pump/patch. Credit: Diabeloop SAS 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. http://www.bioworld.com/articles/433748 Mon, 16 Mar 2020 12:00:00 -0400 https://www.bioworld.com/articles/433748-beta-o2-technologies-to-begin-human-trials-on-new-artificial-pancreas 3-16-Beta-Air-pancreas.png ßAir bio-artificial pancreas. Credit: Beta-O2 Technologies Ltd. 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. BioWorld.]]> http://www.bioworld.com/articles/432969 Mon, 10 Feb 2020 12:00:00 -0500 https://www.bioworld.com/articles/432969-carmat-wins-ok-from-the-fda-for-its-us-clinical-feasibility-study Approved stamp HONG KONG – Matricelf Ltd., an Israeli medical 3D printing company based in Tel Aviv, has won a SEED AWARD and the ¥1 million (US$143,000) that goes with the prize. The Global Final of the SEED AWARD 2019 was held in Shenzhen, China. The organizer Seedland Group, China’s leading real estate company promoting technology innovation, said that Matricelf is working toward one day being able to manufacture the world’s first functional 3D printed human heart. http://www.bioworld.com/articles/431737 Wed, 11 Dec 2019 12:00:00 -0500 https://www.bioworld.com/articles/431737-matricelf-wins-seed-award-with-3d-printing-heart-design Seedling growing in cracked pavement PARIS – Carmat SA, from Vélizy Villacoublay, France, has just raised $66 million from European specialist investors in the life sciences and medical technologies sector. http://www.bioworld.com/articles/430114 Wed, 09 Oct 2019 00:00:00 -0400 https://www.bioworld.com/articles/430114-carmat-raises-66m-to-boost-clinical-commercial-development-of-its-tah Boston startup Beta Bionics Inc. is headed into a pair of ambitious pivotal trials in 2020: one starting for an autonomous bionic pancreas device with insulin only and another to follow for a bihormonal version that also includes glucagon. These are expected to offer more precise, easy-to-use blood glucose maintenance for type 1 diabetes patients. http://www.bioworld.com/articles/420311 Tue, 11 Jun 2019 00:00:00 -0400 https://www.bioworld.com/articles/420311-beta-bionics-completes-first-home-use-trial-of-its-bihormonal-bionic-pancreas-in-t1-diabetes