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transmedics

TransMedics skyrockets on Q1 results, increased 2022 guidance

May 4, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, News Well, Transplants, Wall Street Beat Tagged With: transmedics

FDA approves Transmedics OCS Heart organ transplant system

April 28, 2022 By Sean Whooley

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 […]

Filed Under: Cardiovascular, Clinical Trials, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Transplants Tagged With: FDA, transmedics

TransMedics soars as revenues beat The Street by $2M

February 24, 2022 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, News Well, Transplants, Wall Street Beat Tagged With: transmedics

FDA approves Transmedics’ OCS Liver preservation system

September 29, 2021 By Danielle Kirsh

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Implants, Pre-Market Approval (PMA), Regulatory/Compliance, Transplants Tagged With: transmedics

FDA approves TransMedics’ OCS Heart system

September 7, 2021 By Sean Whooley

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 […]

Filed Under: Cardiovascular, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Transplants Tagged With: FDA, transmedics

FDA clears TransMedics OCS Lung System

July 30, 2021 By Chris Newmarker

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 […]

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Transplants Tagged With: transmedics

FDA advisory panel gives positive ruling on TransMedics OCS Liver System

July 15, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Transplants, Wall Street Beat Tagged With: FDA, FDA advisory panels, transmedics

Nasdaq halts trading of TransMedics stock with FDA set to review OCS Liver System

July 14, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Transplants, Wall Street Beat Tagged With: FDA, FDA advisory panels, NASDAQ, transmedics

TransMedics says FDA advisory committee will review its OCS Liver System in July

June 11, 2021 By Sean Whooley

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Transplants Tagged With: FDA, FDA advisory panels, transmedics

TransMedics slides on Q1 earnings miss

May 5, 2021 By Sean Whooley

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 […]

Filed Under: Business/Financial News, Featured, MassDevice Earnings Roundup, Transplants, Wall Street Beat Tagged With: transmedics

FDA advisory committee positive about TransMedics’ OCS Heart system

April 8, 2021 By Danielle Kirsh

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Structural Heart Tagged With: transmedics

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