MHRA Makes Changes to Quicksite, Quickflex Alert June 30, 2016 The agency updated a 2012 medical device alert for Quicksite and Quickflex devices. Read More
Stryker Initiates Global Recall of Select Target Nano Neuro-coils June 30, 2016 The recall was prompted by issues with substandard stretch resistance. Read More
Court Rejects Review of Ethicon’s Loss Against Covidien June 30, 2016 The company’s petition for a full bench hearing was rejected 10-1. Read More
SRS Medical Scores CE mark for Spanner Stent June 29, 2016 The stent is intended for patients with bladder outlet obstruction. Read More
Health Canada Approves Baxter’s AMIA June 29, 2016 The company plans on launching the system in late 2016. Read More
Ethicon Voluntarily Withdraws Physiomesh June 29, 2016 Patients already implanted with the product should be followed as usual. Read More
Analogic Ends Foreign Bribery Charges Against Distributor June 29, 2016 Analogic agreed to pay nearly $15 million. Read More
China Says Device Distributors Must Conduct Self-Inspections June 29, 2016 The requirement applies to distributors of Class II and III devices. Read More
Resmon Pro Full Wins FDA Clearance June 28, 2016 The device was developed by Restech Respiratory Technology. Read More
UK Probe Maker’s Supplier Controls Fall Short June 28, 2016 The UK probe maker did not set requirements to evaluate suppliers. Read More
FDA Classifies Power Morcellation Containment Systems as Class II Devices June 28, 2016 The systems are intended for gynecologic laparoscopies. Read More
CorMatrix Earns CE Mark Approval for CanGaroo June 28, 2016 The device nabbed FDA clearance in August 2014. Read More