Device Trade Group Identifies Highest-Priority FDA Guidance March 16, 2017 Three of the guidances involve IVDs. Read More
Medtronic Joins Call for Anti-Kickback Statute Safe Harbor March 16, 2017 The proposed safe harbor would facilitate more flexible payments between device manufacturers and buyers. Read More
FDA Cites Lusys Labs for Design Control, Other Procedures March 16, 2017 Inspectors observed the company had not established design control procedures for several of its Zika virus tests. Read More
Grassley Questions EpiPen Rival’s Pricing Policy March 16, 2017 This pricing policy raises similar concerns to those for the EpiPen. Read More
FDA Expands Clearance of Millar’s Pressure Catheter March 15, 2017 The expansion adds to the Mikro-Cath's previous clearance for use in cardiovascular pressure monitoring. Read More
DJO Global Wins FDA Marketing Clearance for Exprt Revision Hip March 15, 2017 The joint implant connects the femoral bone to the hip. Read More
FDA Awards Marketing Clearance to First Ray’s Expanded Stealth Staple Product Line March 15, 2017 New sizes have been added to the product portfolio. Read More
Obamacare Replacement Bill Would Permanently Repeal Device Tax March 15, 2017 The bill was approved by both the House Ways and Means Committee and House Energy and Commerce Committee. Read More
Pulse Biosciences Submits Marketing Application for PulseTx System March 14, 2017 NPS is a non-thermal drug-free tissue treatment technology. Read More
Health Canada Clears Conavi Medical’s Echocardiography System March 14, 2017 The device system is a catheter-based ultrasound system. Read More
Teleflex Receives FDA Clearance for Dual Access Catheter March 14, 2017 The catheter contains both a rapid-exchange lumen and an over-the-wire lumen. Read More
Petition Calls on FDA to Set Timeline for Designation Appeals Process March 14, 2017 Appeals for some products are particularly susceptible to delays. Read More