Smiths Medical Receives FDA 510(k) Clearance for Wireless Ambulatory Infusion Pump August 31, 2017 The device launched last year in Canada, Australia, New Zealand, Ireland and the United Kingdom. Read More
FDA Marks Down Compounder for Aseptic Shortfalls August 31, 2017 Workers at the compounding pharmacy used non-sterile wipes to clean a sterile area. Read More
Regentis Biomaterials Gets Expanded CE Mark for GelrinC August 30, 2017 The implant naturally degrades within 6 to 12 months as it’s replaced by cartilage. Read More
Cardio Indication Approved for Diabetes Drug August 30, 2017 Victoza is approved for adults with diabetes 2 or cardiovascular disease. Read More
C.R. Bard Lands Additional Indication for Drug-Coated Balloon Catheter August 29, 2017 The approval was based on an investigational device exemption clinical trial that showed sustained clinical benefit and safety. Read More
MHRA Approves Dovonex Psoriasis Ointment August 29, 2017 The ointment contains the vitamin D analog calcipotriol. Read More
FDA Clears Stryker’s Pedicle Screws August 28, 2017 The Serrato screws can be customized to fit the patient’s needs. Read More
Appeals Court Revives Antitrust Suit Over Generic Lipitor, Effexor XR August 28, 2017 The U.S. Court of Appeals for the Third Circuit in Philadelphia reversed the earlier ruling. Read More
FDA Clears XSTAT to Stop Gun and Knife Wounds in Arms and Legs August 25, 2017 The devices have previously been FDA approved to treat wounds around the groin and shoulders. Read More
New Gout Medication Gets Green Light from FDA August 25, 2017 The drug combines the standard for gout treatment, allopurinol, with lesinurad. Read More
FDA Adds UL 2900 Cybersecurity Standard to Recognized Medical Device Standards August 24, 2017 The standard covers assessments of network-connectable devices for malware, software limitations and vulnerabilities. Read More
FDA to Tweak Pre-Submission Draft Guidance for GDUFA II August 24, 2017 The agency will give companies the option to pre-submit ANDA sections. Read More