FDA Deflates Sales, Imports of Dutch Endorectal Balloons September 18, 2017 QLRAD promoted the device for use with radiation therapy on its web site and in brochures distributed at medical conferences, the FDA said. Read More
FDA Sacks Eye-Sync as Concussion Assessment Device September 18, 2017 The device resembles a set of virtual-reality goggles connected wirelessly to a suitcase-sized, portable input processing unit. Read More
FDA Approves Two Ortho Hepatitis B Assays September 18, 2017 The assays are used to diagnose individuals with acute or chronic hepatitis B or in recovery from hepatitis B infection. Read More
FDA Clears Agilent’s GenetiSure Dx Postnatal Assay September 18, 2017 The device is intended for use on the Agilent SureScan Dx microarray scanner system. Read More
Edap Seeks New Marketing Clearance for Ultrasound Device September 15, 2017 The new application includes a new set of clinical data. Read More
Douglas Medical Products Wins FDA 510(k) Clearance for IV Administration Set September 15, 2017 The company said it will launch the product immediately. Read More
Pulse Biosciences Pulls FDA 510(k) Application September 14, 2017 The company plans to re-file with additional information. Read More
Leica Wins FDA Clearance for Novel Microscopy Filter September 14, 2017 The device combines two illumination methods. Read More
FDA Releases Guidance on Interoperable Devices September 13, 2017 The final guidance includes recommendations for labeling and premarket submissions. Read More
Gecko Biomedical Receives CE Mark Approval for SETALUM Sealant September 13, 2017 The sealant is the most recent successful example of bio-inspired technology in medicine. Read More
FDA to Pilot New High-Risk PMA for Medical Devices September 13, 2017 Participants in the PMA CtQ program would agree to post-approval inspections. Read More
Migraine Treatment Device Wins Marketing Clearance September 12, 2017 Devicemaker eNeura received 510(k) clearance from the FDA for the eNeura Spring TMS for treatment of migraine headache. Read More