China Introduces Routine Overseas Device Inspections January 16, 2019 Devices approved for marketing in China are subject to the new regulations. Read More
MIM Software Cleared for Molecular Radiotherapy Dosimetry January 16, 2019 The SurePlan MRT allows for personalized dosimetry measurements. Read More
FDA Brings Back More Staff for Inspection Activities January 16, 2019 Approximately 100 staff members will carry out inspections of high risk medical device manufacturing facilities. 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
AdvaMed Suggests Health Canada Revise 3D Printing Guidance January 15, 2019 It is unclear if there are higher expectations for Class III 3D-printed devices, AdvaMed said. 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
Endologix Appoints New Chief Commercial Officer January 14, 2019 Zehren previously served at Medtronic, Covidien and ev3. 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 Expands Excepted Device Activities During Government Shutdown January 14, 2019 “FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations,” Gottlieb said. 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