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
CAPAs, Change Controls Spell Trouble for Medtronic Unit June 28, 2016 The letter addresses a Medtronic subsidiary that makes absorbable antibacterial envelopes. Read More
John Sheets Tapped as New Director of ODE June 27, 2016 Sheets began his new duties on June 12. Read More
Akers Biosciences, Aero-Med Ink Distribution Deal June 27, 2016 Financial terms of the deal were not disclosed. Read More
BioVentrix Scoops Up CE Mark Approval for Revivent TC June 27, 2016 The system excludes scarred myocardium from the healthy tissue of the LV. Read More