Magnolia Grabs Further FDA Clearance for Blood Collection System March 6, 2020 After diverting the amount of blood known to contain contaminants, the device collects the blood culture through a secondary flow path. Read More
Reflow Earns Expanded FDA Clearance for Crossing Catheter March 6, 2020 The catheter showed a 90 percent success rate in a clinical trial. Read More
CryoLife’s Hybrid Stent Graft Nabs Mark March 5, 2020 The device reduces surgical time while improving the safety of the procedure. Read More
Randox’s Multi-STI Assay Receives CE Mark March 5, 2020 The cartridge-based test detects multiple STIs, including co-infections, using a single patient sample. Read More
Elitech Earns CE Mark for COVID-19 Diagnostic March 5, 2020 The test kit confirms the quality of the extracted sample material. Read More
Mauna Kea Technologies’ Endomicroscopy Platform Gains Clearance March 4, 2020 The system can use other endomicroscopy devices for fluorescence-guided surgery and molecular imaging. Read More
Life Spine Earns 510(k) Clearance for Lateral Expandable System March 4, 2020 The device uses a bulleted tip to simplify insertion. Read More
DxTerity Earns CE Mark for Finger Stick Blood Collection Tube March 3, 2020 The device can stabilize blood samples at room temperature. Read More
Federal Judge Rules EpiPen Class Action Can Go Ahead March 2, 2020 The complaint alleges that the price of EpiPen increased by more than 600 percent under Mylan’s ownership. Read More
Ibex Earns CE Mark for Cancer Detection Software February 28, 2020 The software uses an algorithm formulated from more than 60,000 prostate slides. Read More
FDA Clears Pavmed’s Esophageal DNA Diagnostic February 28, 2020 The diagnostic screens for methylation at 31 sites on two genes using next generation sequencing. Read More
Baxter Obtains FDA Clearance for Staple Reinforcement Strip February 28, 2020 The adhesive strip can easily manipulate tissue. Read More
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