Fujirebio Gets Breakthrough Designation for In Vitro Diagnostic Test February 14, 2019 The results are meant to help assess patients aged 50 or older that are experiencing cognitive impairment. Read More
Hologic’s HIV-1 Assay Receives Two CE Marks February 14, 2019 Hologic says the assay is the only HIV diagnostic test with dual-claims for both viral load and early infant diagnosis. Read More
Intrinsic Therapeutics Receives PMA for Spinal Implant February 13, 2019 The device consists of a woven polyester component attached with a titanium anchor. Read More
Bausch + Lomb Receive 510(k) Clearance for Contact Lens Coating February 13, 2019 The high-water polymer coating that bonds to the contact lens’ surface, helps ease contact lens dryness and discomfort. Read More
FDA Clears LaserOptek’s Picosecond Laser February 13, 2019 The device is designed to treat pigmented lesions and can perform tattoo removals, skin rejuvenation and scar corrections. Read More
Delcath’s Hepatic Delivery System Approved in Brazil February 12, 2019 The system lowers the chemotherapeutic agent’s concentration after it leaves the target organ. Read More
Synopsys Launches 3D Imaging Tool After Gaining CE Mark February 12, 2019 The tool can be used for simulating and evaluating a patient’s surgical treatment options. Read More
FDA Approves Grifols’ Babesia Test February 11, 2019 Babesia is a malaria-like parasite that can be spread through blood from infected donors. Read More
FDA Exempts Certain Unclassified Devices From Premarket Notification February 8, 2019 Products exempt from premarket notification requirements include fertility diagnostics and a spine curvature device. Read More
VentureMed Group Appoints New CEO February 8, 2019 Paulson previously served as Restore Medical’s president and CEO, where he guided Medtronic’s 2008 acquisition. Read More
Orchestrate Orthodontics’ 3D Printing Software Cleared for Marketing February 8, 2019 The software system allows dentists to design and produce their own orthodontic clear aligner appliances. Read More
Altona Gains CE-IVD Mark for Hep C Diagnostic Kit February 8, 2019 The test is for use with the devicemaker’s AltoStar automation system. Read More