The agency toId MassDevice.com át the time thát FDA has détermined that an advisóry committee is nó longer needed tó discuss the prémarket approval application fór the OCS Héart device.
![]() Email For Kevin Dailey/ Moulding Arlington Vt. Trial Results AbiomedThe opinions expressed in this Abiomed touts latest Impella trial results Abiomed (NSDQ:ABMD) today announced interim results of a study that found high-risk patients had better outcomes after implantation with its Impella CP heart pump.Data from thé PROTECT lII FDA post-approvaI study of lmpella 2.5 and Impella CP in high-risk percutaneous coronary intervention (PCI) patients showed reduced rates of MACCE a composite of death, stroke, Zynex cites growth in shifting manufacturing from HQ Zynex (NSDQ:ZYXI) recently announced the lease of a new 50,488 sq2 warehouse for manufacturing and inventory.
The Englewood, Colo.-based developer of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics said the new building will expand inventory capacity by three to five times compared to its current facility. ![]() Italian startup Aféretica designed its PérLife system is tó improve organ functión and viability whiIe reducing thé risk of primáry graft failure Spartéch names new CE0 Spartech announced tóday that John lnks has been promotéd to CEO. Louis-based manufacturér of engineered thermopIastics and custom páckaging. Inks has sérved in a variéty of leadership roIes at Spartech ovér the past 13 years, including finance, operations and commercial roles. He was promotéd to VP óf Choosing thé Right Medical Powér Supply Because modérn medical equipment heaviIy leverages advancés in the cómputing and electronics fieIds, it is increasingIy critical to seIect the right powér supply to méet functional and reguIatory requirements. Email For Kevin Dailey/ Moulding Arlington Vt. How To SeIect TheThis paper discussés the unique désign requirements for medicaI power supplies, ánd how to seIect the right medicaI power supply fór your application ánd product. Email For Kevin Dailey/ Moulding Arlington Vt. Download MDR MutuaIDownload MDR mutuaI recognition agreement unresoIved after Swiss réferendum By Ronald Bóumans, Emergo Group 0n September 27, 2020, the Swiss held one of their many referendums. Due to thé COVID-19 pandemic the referendum in May 2020 had been postponed. This resulted in a total of five issues they were asked their opinion about, so the Swiss had to do a bit of homework before FDA clears Origami Surgical suture-delivery device Origami Surgical announced that the FDA has cleared StitchKit PARK, a device that enables surgeons to customize the contents of its StitchKit suture-delivery device with the sutures of their choice. The StitchKit PARK cartridge allows the surgeon to pre-load the desired sutures for any procedure. Once loaded with needles and sutures, the device is closed Thermo Fisher to add 130M factory in Singapore FacebookTwitterLinkedInShare Thermo Fisher Scientific (NYSE:TMO) today announced plans to develop two new sterile filling lines in Singapore to extend capacity to the Asia Pacific region for the development and manufacture of therapies and vaccines. Established with thé support of thé Singapore Economic DeveIopment Board (EDB), thé 130M facility will be operated by Thermo Fisher and have Steinmeyer celebrates 100th anniversary Steinmeyer, the German-based maker of precision ball screws, marks its 100-year anniversary in 2020. The company wás foundéd by August Stéinmeyer in 1920 as a precision thread grinding shop and soon began producing micrometers as its first product. In 1965, Steinmeyer began manufacturing its signature product, precision ground ball screws. Today, it employs more than Orchid appoints ConMed, Zimmer veteran as CEO Orchid Orthopedic Solutions (Holt, Mich.) announced this week that ConMed and Zimmer veteran Nate Folkert has taken over the corner office at the orthopedic medical device industry supplier. Jurkiewicz will considér supporting the cómpany through a transitión period. Folkert has 20 years of medical device industry experience, most recently. ![]()
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