Two years into the COVID-19 pandemic, we know more than ever about the SARS-CoV-2 virus and how quickly it moves to ravage the human body. What remains to be seen is how the virus — and perhaps more importantly, our immune system’s response to it — will affect the health of people long after infection, […]
Transplants
TransMedics skyrockets on Q1 results, increased 2022 guidance
TransMedics (Nasdaq:TMDX) shares got a massive boost today on first-quarter sales that were 64% higher than the consensus forecast. TMDX shares were up more than 30% at $28.44 apiece by midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down slightly. The Andover, Massachusetts–based […]
FDA approves Transmedics OCS Heart organ transplant system
TransMedics (Nasdaq:TMDX) announced today that it received FDA premarket approval (PMA) for its OCS Heart system. FDA PMA allows Andover, Massachusetts-based TransMedics to expand the pool of eligible heart donors in the U.S. to organs from donors after circulatory death (DCD). The company had previously received PMA for the OCS Heart system for use with […]
TransMedics soars as revenues beat The Street by $2M
TransMedics (NSDQ:TMDX) shares were up more than 27% today after it reported Q4 revenues that beat Wall Street expectations by more than $2 million. Regulatory wins enabled the Andover, Massachusetts–based organ preservation tech company to bring in $9.7 million during the quarter ended Dec. 31, 2021, representing 26.8% sales growth from Q4 2020. Analysts were […]
OrganOx wins FDA PMA for its donor liver transport device
OrganOx announced today that it received FDA premarket approval (PMA) for its metra normothermic machine perfusion (NMP) system. Oxford, England–based OrganOx designed its metra system as a fully automated NMP device for the preservation and transport of donor livers set for transplantation. The transportable device sustains donor livers in a functioning state for up to […]
FDA approves Transmedics’ OCS Liver preservation system
TransMedics (NSDQ:TMDX) today announced that it has received FDA premarket approval for its OCS Liver system for use with organs from donors after brain death and circulatory death. Andover, Massachusetts–based Transmedics designed the device to preserve and monitor the hemodynamics and metabolic function. It allows for ex-vivo assessment of liver allografts from brain dead and circulatory […]
FDA approves TransMedics’ OCS Heart system
TransMedics (NSDQ:TMDX) announced today that it received FDA premarket approval for its OCS Heart system. Andover, Massachusetts-based TransMedics designed its OCS Heart system for use with organs from donors after brain death with indication for preserving donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic […]
FDA clears TransMedics OCS Lung System
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 […]
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 […]
