Three years ago, Mylan (NSDQ:MYL) began holding summits for food allergy bloggers to learn about its campaign to get its EpiPen epinephrine injector into schools. Many of the bloggers, mothers of children with serious allergies, were eager to help. Some, including Ruth LovettSmith, wrote thousands of posts, providing testimony that some legislators say convinced them […]
Food & Drug Administration (FDA)
Big Pharma urges acquittal for ex-Acclarent execs
Pharmaceutical giants including Bayer (ETR:BAYN) and Pfizer (NYSE:PFE) filed a motion backing ex-Acclarent executives William Facteau and Patrick Fabian, urging the Massachusetts federal court to acquit them of their misdemeanor charges. Former Acclarent CEO Facteau and ex-sales vice president Fabian were convicted in July on 10 misdemeanor counts of “introducing adulterated and misbranded medical devices into […]
Mylan CEO testifies before Senate about EpiPen pricing
Mylan CEO Heather Bresch testified before Senate yesterday after the Oversight and Government Reform Committee expressed concerns about the company’s price increases of its epinephrine auto-injector. Since Mylan (NSDQ:MYL) acquired the EpiPen from Merck in 2007 it has raised the price 17 times, from $100 in 2008 to nearly $600 today – a price increase of […]
Global Kinetics wins FDA nod for 2nd-gen wearable kinetigraph
Global Kinetics Corp said today it won FDA 510(k) clearance for its next-gen wrist-worn personal kinetigraph system. The device is designed to record movement symptoms of Parkinson’s and provides medication reminders and aid in making assessments about response to medication, the Melbourne, Australia-based company said. “Our new second generation PKG represents the most recent milestone in […]
FDA releases priorities for national device evaluation system
The FDA, in association with the Duke Margolis Center for Health Policy, released a report yesterday establishing guidelines for the development of the National Evaluation System for health Technology. The NEST aims to operate as a “cooperative network of partners working to use data, advanced methodologies, and good governance to improve the state of medical device […]
Levita Magnetics wins Class II status for gallbladder surgery device
The FDA today announced that it reclassified Levita Magnetics’ magnetic surgical system, cleared for gallbladder removal surgeries, as a Class II device. The system is designed to retract and maneuver the gallbladder using magnetic fields, which the San Mateo, Calif.-based company said “reduces the number of incisions” necessary for the procedure and prevents damage to the […]
FDA clears components for K2M’s Mesa spine implant
K2M (NSDQ:KTWO) said today it won FDA 510(k) clearance for screw and connector components used as part of the company’s Mesa spinal system. The newly cleared components from the Leesburg, Va.-based company are designed to be used as part of a growing rod construct designed to accomodate growth in pediatric patients 10 years and younger. “We are […]
House committee probes FDA’s ‘Botox police’
A U.S. House committee launched a probe of the FDA’s criminal office, raising questions about the unit’s management and handling of cases involving devices, food and drugs. The U.S. House Energy & Commerce Committee told FDA commissioner Dr. Robert Califf that it’s “examining management concerns” and “possible morale concerns with the field offices” of the federal safety […]
Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements. The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead […]
GI-View wins FDA clearance for Aer-O-Scope disposable colonoscope
GI-View said today that its Aer-O-Scope colonoscopy device won 510(k) clearance from the FDA. The company’s flagship product is a disposable colonoscope with 2 channels for tools to take biopsies during a colon cancer screening. The device is the 1st colonoscope to provide a 360-degree view of the colon to detect polyps behind folds, according […]
FDA clears Life Spine’s Pro-Link Ti cervical spacer
Life Spine said today that it won 510(k) clearance from the FDA for its Pro-Link Ti cervical spacer. The Huntley, Ill.-based company said the product is slated for full release by the end of 2016, joining a portfolio of devices that Life Spine launched this year. The spacers allow for the fusion of adjacent segments […]