Balt Nabs CE Mark for Long Sheath March 21, 2019 The device features a low-profile outer diameter. Read More
Endospan Earns CE Mark for Aortic Arch Repair System March 20, 2019 The system removes the need to open the patient’s chest or cut the aorta. Read More
FDA Clears Implanet’s Screw Securing Device for Vertebral Fusion March 20, 2019 The implants are composed of a band, a screw, and the company’s patented locking mechanism. Read More
Omega Diagnostics’ HIV Monitoring Test Receives CE Mark March 19, 2019 The company noted an unmet need in low and middle-income countries for a test that can identify patients with advanced HIV infection. Read More
Nyxoah’s Obstructive Sleep Apnea Device Earns European Approval March 19, 2019 The device delivers nerve stimulation for patients with moderate to severe sleep apnea. Read More
Abbott Gains CE Mark for Diagnostics System and Assays March 19, 2019 The system saves laboratory space and time by performing the functions of several devices. Read More
FDA Green Lights Biotronik’s Tachycardia Devices March 18, 2019 The battery-powered products are independent of AC power. Read More
Via Surgical Gains 510(k) Clearance for Lockable Surgical Mesh March 18, 2019 The lightweight sutures provide a strong fixation. Read More
Zyppah’s Anti-Snoring Device Cleared for OTC March 18, 2019 Zyppah calls the product a “seatbelt” for the tongue. Read More
FDA Allows Marketing of Device for Carbon Monoxide Treatment March 15, 2019 ClearMate makes the patient breathe faster to speed up the rate of carbon dioxide exiting the body. Read More
FDA Grants New Indication for Valve Repair Device March 15, 2019 The new indication is for treating patients with moderate-to-severe or severe mitral regurgitation due to diminished left heart function. Read More
HemoSonics’ Quantra QPlus System Earns De Novo Authorization March 14, 2019 The results can be used in managing critical bleeding after cardiac and orthopedic surgeries. Read More