TransMedics (NSDQ:TMDX) has won FDA clearance of its OCS Lung System to provide hypothermic flushing, storage and transportation of donor lungs for transplantation. “This FDA clearance marks another achievement for TransMedics as we assemble the most comprehensive, market-leading portfolio of organ preservation products to meet the clinical needs of the organ transplant market,” TransMedics CEO […]
Transplants
FDA advisory panel gives positive ruling on TransMedics OCS Liver System
TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote supporting approval for its OCS Liver System. Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review […]
Nasdaq halts trading of TransMedics stock with FDA set to review OCS Liver System
TransMedics (NSDQ:TMDX) announced today that the Nasdaq market halted trading of the company’s common stock. Andover, Mass.-based TransMedics, which develops organ transplant transportation platforms, saw its common stock close down -5.3% at $31.69 yesterday. The company awaits the outcome of today’s meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory […]
TransMedics says FDA advisory committee will review its OCS Liver System in July
TransMedics (NSDQ:TMDX) announced that the FDA confirmed that it will review its premarket approval application next month. Andover, Mass.–based TransMedics said the FDA scheduled a public advisory committee meeting to review the PMA application for the OCS Liver System, an organ transplant transportation platform, for July 14, 2021. In the committee meeting, the FDA’s Gastroenterology […]
TransMedics slides on Q1 earnings miss
TransMedics (NSDQ:TMDX) shares took a massive hit today on first-quarter results that missed the consensus earnings forecast. TMDX shares were down -12.4% at $24.58 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -1.2%. The Andover, Mass.-based organ transplant technology […]
UC Berkeley researchers tout tiny sensor that can detect tissue oxygen levels
Engineers at the University of California, Berkeley, are touting an implant that can provide real-time measurements of tissue oxygen levels. The tiny wireless device is smaller than a ladybug and powered by ultrasound waves to help monitor the health of transplanted organs or tissue through real-time measurements of oxygen levels in tissues deep beneath the […]
Paragonix launches lung preservation and transport system
Paragonix Technologies announced today that it launched its LUNGguard donor lung preservation system in the U.S. and Europe. Cambridge, Mass.–based Paragonix designed the LUNGguard for the hypothermic preservation of lungs during transportation and the eventual transplantation into a recipient using cold storage solutions. LUNGguard is indicated for a storage time of up to eight hours, […]
Aferetica, CytoSorbents gain EU nod for organ perfusion system
CytoSorbents (NSDQ:CTSO) and Aferetica today announced the European Union approval of Aferetica’s PerLife integrated ex-vivo system to perfuse, cleanse, recondition and preserve harvested kidneys and livers — including those that are usually discarded. Italian startup Aferetica designed its PerLife system is to improve organ function and viability while reducing the risk of primary graft failure and organ rejection. […]
Fresenius to enter heart, lung, organ failure markets
Fresenius Medical Care (NYSE:FMS) announced today that its new growth strategy includes treating heart, lung and multi-organ failure. Hamburg, Germany-based Fresenius’ strategy centers around three major areas: renal care, critical care solutions and complementary assets, according to a news release. The company’s renal care continuum is to be bolstered by artificial intelligence and data analysis technologies […]
TransMedics to get its virtual day with FDA panel on heart transplant tech
After a six-month pandemic-related delay, TransMedics (NSDQ:TMDX) is set to have an FDA panel review the premarket approval application for its donor heart transport technology on October 7, 2020. TransMedics’ organ care system (OCS) technology is designed to keep donated hearts, lungs and livers in near-living condition until transplantation. The FDA approved the Andover, Mass.-based company’s […]
CMS pushes for return to essential kidney treatments, transplants
The Centers for Medicare & Medicaid Services (CMS) has announced updated guidance urging for the resumption of kidney procedures. CMS said its guidance is designed to ensure medical providers can able return to offering essential surgical, life-sustaining procedures while reinforcing infection control precautions at dialysis facilities in COVID-19 hotspots. The guidance includes a checklist of […]
