By Following OIG Recommendation, Medicare Would Have Saved Millions April 28, 2015 Medicare payments were based on average sales prices over the previous half year rather than on the cheaper average wholesale prices. Read More
Avita Medical Wins CE Mark for New ReCell Device April 27, 2015 The second generation burn treatment features a six-fold greater coverage area than an earlier model. Read More
Teva Settles Provigil Lawsuit for $512 Million April 27, 2015 The drugmaker could still face billions more in court-ordered payments. Read More
Nipro Diagnostics Wins FDA Approval for True Metrix Air April 24, 2015 The self-monitoring blood glucose system can wirelessly deliver data to a smartphone. Read More
FDA Pushes Genervon to Release All Trial Data on ALS Drug April 24, 2015 The FDA says it will use all expedited development and approval pathways available to further treatments of the disease. Read More
Medtronic’s Neurostimulators Snag Expanded EU Indication April 23, 2015 The device is the only one of its kind approved for full-body MRI scans, company claims. Read More
Counterfeit Botox Shows Up in the U.S. April 23, 2015 The FDA is advising providers to check with Allergan to determine if they purchased Botox from an authorized distributor. Read More
FDA Grants Great Basin’s Strep Test 510(k) Clearance April 22, 2015 The company plans to launch the assay in the second quarter of this year Read More
EMA Updates Reporting Requirements for Nonserious Medication Errors April 22, 2015 Drugmakers should disclose the errors in safety update reports and risk-management plans. Read More
Cardiovascular Systems’ Smaller Diamondback 360 Wins FDA Nod April 21, 2015 The device can treat peripheral arterial disease with smaller incisions at below the knee sites. Read More
HHS Investigates Rising Generics Prices April 21, 2015 HHS wants to know whether recent price increases have exceeded inflation rates. Read More
Syneron Candela’s Picosecond Laser Wins FDA, Health Canada Nods April 20, 2015 The PicoWay can be used for tattoo removal or the treatment of pigmented lesions. Read More