RevMedx’s Self-Expanding Gauze Gains CE Mark March 21, 2019 The sponges expand to ten times their original size, making them useful for wound-packing and treating certain traumatic injuries. Read More
Hitachi Chemical Receives 510(k) Clearance for Multiplex Allergy Tester March 21, 2019 The system automatically checks the device’s performance before each analysis. Read More
FDA Clears Beckman Coulter’s Hematology Analyzer March 21, 2019 The tabletop system removes the need for sample exposure. Read More
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