Baxter (NYSE:BAX) warned patients with ascites of a potential software problem with its HomeChoice peritoneal dialysis machine that could cause low blood pressure and "hemodynamic compromise," according to a field alert.
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Boston Scientific breathes easy with China win for Alair
Boston Scientific (NYSE:BSX) said the Chinese FDA approved its Alair bronchial thermoplasty system for treating patients with persistent asthma.
Stryker nearly doubles estimate on recall costs
Stryker (NYSE:SYK) said yesterday that the cost of the recalls of its Rejuvenate and ABG II hip implants could top $1 billion, nearly double its prior estimate.
The Kalamazoo, Mich.-based orthopedic medical device company said in a regulatory filing that it now expects the recalls to cost between $700 million and $1.13 billion.
Single QMS audit program pilot for medical devices set for January 2014
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Australia, Brazil, Canada and the US are preparing to launch a pilot for their Medical Device Single Audit Program (MDSAP) in January 2014.
Aesthetic: Allergan lands FDA win for Juvederm facial filler
Varian Medical lands FDA clearance for treatment software
Varian Medical (NYSE:VAR) said it won 510(k) clearance from the FDA for its RapidPlan treatment planning software.
U.K. healthcare regulators warn of ‘buckling’ Becton Dickinson catheters
Medtronic recalls dilation catheters over labeling issue
FDA puts highest-risk label on GE Healthcare recall
EU Parliament: No PMAs here please
The European Parliament today failed to back an EU panel’s recommendation to enact strict requirements for medical device approvals that would have matched those required by the FDA’s pre-market approval program.
The EU body voted instead to strengthen the rules by authorizing unannounced inspections and more stringent monitoring of the "notified bodies" that govern medical device regulation there.