FDA Permits de novo Clearance for AirXpander’s Tissue Expander System December 23, 2016 The device is designed for patients who chose reconstructive surgery after a mastectomy. Read More
Written MDR Procedure Lands Miramar Labs a Form 483 December 23, 2016 The MDR procedure did not have instructions to file MDRs for overseas incidents for devices also marketed in the U.S. Read More
Complaint Evaluation Procedures Net Circle Prime Form 483 December 23, 2016 Records of acceptable suppliers, contractors and consultants were not being adequately established. Read More
HHS OIG Work Plan Focuses on Recalled Devices, Cybersecurity December 23, 2016 The OIG will review Medicare claims to identify how much it costs replace recalled devices. Read More
ZipLine Medical Nabs CFDA Approval for Skin Closure Device December 22, 2016 The Zip is a non-invasive wound closure device. Read More
EC Grants CE Mark to InSightec’s Exablate Prostate System December 22, 2016 The device uses focused ultrasound waves to target and destroy specific tissue in the prostate. Read More
Poor Supplier Evaluations Lead To Form 483 for CME America December 22, 2016 Potential suppliers were not evaluated and selected based on their ability to meet specified requirements. Read More
ANSM Issues Instructions For Clients of Denotified Bodies December 22, 2016 Manufacturers must submit five criteria when applying for a marketing extension. Read More
Iradimed Corporation Scores FDA Clearance for MRI Compatible IV Infusion Pump December 21, 2016 The compatible device delivers fluids during MRI procedures. Read More
FDA Grants Marketing Clearance to Cepheid’s Next-Generation Test for MRSA Colonization December 21, 2016 Xpert MRSA NxG is a molecular test that delivers results in about an hour. Read More
FDA, CMS Parallel Review Program To Be Made Permanent December 21, 2016 The agencies learned two primary lessons from the pilot program. Read More
Multi-Part Device Labeling, Other Issues Dog UDI Rule December 21, 2016 There has been some confusion about who is actually responsible for UDI. Read More