3M (NYSE:MMM) said yesterday that its board of directors nominated CEO Mike Roman as its new chairperson, with current exec chair Inge Thulin announcing their intention to retire. The move is slated to take effect following the St. Paul, Minn.-based company’s annual meeting of shareholders on May 14. “Under Inge’s leadership, 3M evolved into a more […]
Repro-Med defeats an appeal from EMed in needle-stick patent case
Repro-Med Systems (OTC:REPR) emerged victorious as the US Court of Appeals for the Federal Circuit denied an appeal from competitor EMed Technologies in a patent spat over protective needle-stick related technology. In the original case, Repro-Med claimed that a patent EMed owned related to “protection to eliminate needle stick injuries when using needles associated with subcutaneous […]
Repro-Med clears FDA warning letter, shuffles C-suite
Repro-Med Systems (OTC:REPR) said last week that the FDA cleared a 2016 warning letter for its Freedom 60 syringe infusion pump and Freedom Edge infusion pump and made some changes in the executive suite. Repro-Med, which does business as RMS Medical Products, said the closure of the warning letter stemmed from its successful bid for 510(k) clearance […]
Repro-Med updates on FDA warning letter over Freedom Infusion sets
Repro-Med Systems last Friday updated on a warning letter it received in February over issues the FDA found with the company’s Freedom 60 syringe infusion pump and Freedom Edge infusion pumps. The company said it submitted a response to the warning letter last Friday to the FDA, 3 days before the required response date set by […]
UPDATE: FDA warns Repro-Med on Freedom Infusion set issues
Updated with comment from Repro-Med Systems The FDA today released a warning letter it sent to Repro-Med Systems over issues it found with the company’s Freedom 60 syringe infusion pump and Freedom Edge infusion pumps. The letter was in response to an earlier reply from Repro-Med, which the FDA said was “not adequate” for handling the […]
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Knee implants: ConforMIS announces a double dose of good news for its iTotal custom knee implants. | Regulatory Roundup
ConforMIS Inc. had a double-dose of good news today for its iTotal CR custom knee implant. The company touted CE Mark approval in the European Union as well as successful completion of the first surgeries using the knee resurfacing system.
Unlike standard implants, iTotal CR devices are based on an individual’s CT scans and tailored for their knee bones using computer-aided design.
