The U.S. Food and Drug Administration has increased its scrutiny of Indian pharmaceutical companies following recent events of bad practices at a handful of manufacturing facilities, according to a report in The New York Times.
Supply Chain
The U.S. Food and Drug Administration has approved Mountain View, Calif.-based Hansen Medical's Magellan 6Fr Robotic Catheter, according to a Hansen Medical news release.
Emergo Group, a global medical device consulting group, released an outlook report that shows medical device industry professionals around the globe are generally optimistic about the future of the industry, according to a Bionews Texas report.
Plattsburgh, N.Y.-based Medisca has issued a voluntary recall of four lots of L-Citrulline after finding these lots do not contain any L-Citrulline.
Bedford, Ohio-based Ben Venue Laboratories has issued a voluntary recall of one lot of its Acetylcysteine solution, 10 %, USP, due to a glass particle found floating in a vial in the affected lot.
Reports on medical device adverse events will soon be required to be submitted electronically, according to a final rule issued by the U.S. Food and Drug Administration, effective Aug. 14, 2015.
Boulder, Colo.-based JustRight Surgical has received 510(k) clearance from the U.S. Food and Drug Administration to market its 5mm Stapler, according to a news release.
Minnetonka, Minn.-based IMRIS received clearance from the U.S. Food and Drug Administration for the next generation of its VISIUS Surgical Theatre, an intraoperative imaging system.
The U.S. market for disposable medical supplies is projected to be valued at $49.3 billion by 2018, growing at a rate of 4.1 percent per year, according to a Report Linker report.
Florence, S.C.-based McLeod Health and St. Louis, Mo.-based ROi (Resource Optimization and Innovation) have signed a strategic supply chain agreement to improve clinical, financial and operational results for the health system, according to an ROi news release.