Trice Medical Gains FDA Clearance for Mi-Eye 2 October 13, 2016 The device eliminates the need for a MRI. Read More
FDA Grants Lorenz eCTD Contract October 13, 2016 The company will implement its docuBridge, eValidator and Automator solutions. Read More
Device Manufacturers Want Faster Track for Antimicrobial Susceptibility Tests October 13, 2016 In the clinical setting, some physicians are reluctant to prescribe new antibiotic treatments. Read More
FDA Seeks Veterans’ Views on Prosthetic Limbs at Workshop October 13, 2016 The workshop also is intended to engage stakeholders. Read More
PierianDx Acquires Tute Genomics October 12, 2016 Reid Robison, CEO of Tute, will join the PierianDx Board of Directors. Read More
Tute Genomics Stops Crowdfunding for DNA Sequencing Due to FDA Letter October 12, 2016 The company had concluded that the process does not involve what the FDA considers a medical device. Read More
‘SkinPen’ Doesn’t Merit Dermabrasion Exemption, Warning Letter Says October 12, 2016 The agency deemed the SkinPen dermabrasion product adulterated. Read More
Saudi FDA to Regulate Combination Products as Pharmaceuticals October 12, 2016 Existing medical device registrations for these combination products will remain effective until they expire. Read More
St. Jude’s Heart Battery Malfunction Leads to Two Deaths October 11, 2016 The devices could form “lithium clusters” during high-voltage charging. Read More
FDA Approves Spineology’s Interbody Devices with Allograft Bone October 11, 2016 The devices incorporate large graft windows to facilitate healing. Read More
Documentation, Contamination Issues Draw 483 for Chinese Implant Company October 11, 2016 The dental implant manufacturer failed to implement procedures to prevent contamination. Read More
Device Identifiers Would Help CMS Track Defective Products, OIG Says October 11, 2016 The next version of the CMS form due to be released for comment on Dec. 1. Read More