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 […]
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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 […]
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 […]
FDA advisory committee positive about TransMedics’ OCS Heart system
TransMedics (NSDQ:TMDX) this week said that the FDA Circulatory Systems Device Advisory Panel voted in favor of the OCS Heart System. The FDA panel voted 12 to 5, with 1 abstaining, that the benefits of the OCS Heart System outweigh the risks. The panel also voted 10 to 6, with 2 abstaining that there is reasonable […]
TransMedics jumps on Street-beating Q4 results
TransMedics (NSDQ:TMDX) posted fourth-quarter results this week that beat the consensus forecast on Wall Street. The Andover, Mass.-based company — a maker of transplant organ preservation tech — reported losses of -$6.3 million, or -23¢ per share, on sales of $7.6 million for the three months ended Dec. 31, 2020, for a sales growth of 25% […]
MedTech 100 roundup: Stocks show no signs of slowing down
The medtech industry hit further highs in the market last week and the stocks show no sign of stopping their ascent now. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 97.62 (Nov. 6), marking a 7.3% leap from the 91.01 points registered at the […]
TransMedics posts Street-beating Q3 results, despite losses
TransMedics (NSDQ:TMDX) posted third-quarter results that beat the consensus forecast on Wall Street. The Andover, Mass.-based company reported losses of -$5.1 million, or -19¢ per share, on sales of $7.1 million for the three months ended Sept. 30, for a sales loss of -1.6% compared with Q3 2019. Earnings per share were -19¢, 10¢ ahead of […]
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 […]
