IschemaView Gains Expanded Clearance for Neuroimager January 17, 2019 The Rapid system is the only imaging platform currently approved for selecting stroke patients for blood clot removal, the company said. Read More
Gramercy’s Nitinol Staple System Cleared by FDA January 17, 2019 The device provides an array of sterile symmetric and asymmetric, barbed and smooth staples. Read More
FDA Approves Abbott’s Premie Heart Opening Treatment January 17, 2019 The self-expanding, wire mesh device is inserted in the leg and directed through vessels to the heart. Read More
FDA Clears Applied Tissue’s Platform Wound Dressing January 16, 2019 The device applies an even distribution of negative pressure across the wound. Read More
Ultrasonic System Gains 510(k) Clearance January 15, 2019 The system offers reusable instruments with per-procedure costs similar to traditional laparoscopic surgeries. Read More
FDA Clears Additive Orthopedics’ 3D Printed Lattice Plates January 15, 2019 The patient-specific implants will be a component of the company’s integrated surgical planning system it plans to launch later in the year. Read More
Aseptika’s Health and Wellness App Earns CE Mark January 15, 2019 The app displays the data it gathers in descriptive charts and tables to show patient patterns. Read More
Tela, Aroa Receive FDA Clearance for Bioscaffolds January 14, 2019 The device is made up of biologic and synthetic materials. Read More
FDA Clears Ossio’s Bone Pin Family January 14, 2019 The bone pins fully integrate with the patient’s anatomy in approximately 18 to 24 months. Read More
Empatica’s Epilepsy Band Cleared for Pediatric Use January 9, 2019 In a clinical trial of 141 patients with epilepsy, the device had a 98 percent accuracy rate in identifying seizures. Read More
ArcherDX’s Companion Diagnostic Assay Receives Breakthrough Designation January 9, 2019 The sequencing-based assay analyzes more than 50 genes to detect alterations in somatic tumor DNA. Read More
NHS Approves Diabetes Digital Media’s App January 8, 2019 The app is available for Apple and Android devices. Read More