With tens and possibly hundreds of billions of dollars in potential savings still snagged in a regulatory limbo, federal lawmakers and health industry stakeholders strongly urged the Food and Drug Administration last month to knock down the final barriers to review and approval of biosimilar drugs for marketing in the United States.
The Bluetooth Special Interest Group recently adopted the continuous glucose monitoring profile, developed by the Medical Device Working Group, to standardize data collection, measurement and delivery for Bluetooth Smart glucose monitors.
The adoption of personal medical devices and healthcare kiosks that capture consumer health data — like blood pressure and glucose — coupled with data points with a patient’s health record at the pharmacy represents a significant opportunity to enhance disease state management programs.
Close to 100 million wearable, remote patient-monitoring devices will ship over the next five years, according to ABI Research, boosted by growing interest and awareness about the benefits of supporting healthcare away from the hospital and into patients’ homes.
During its annual business review Tuesday, Johnson & Johnson announced that the recent introduction of the OneTouch Verio Glucose testing platform represented one of the first diabetes care devices to alert and display high/low patterns that deliver more meaningful and actionable insights to help patients better understand and manage their diabetes.
The House of Representatives on Wednesday passed legislation that reauthorizes the Food and Drug Administration’s prescription drug user fee programs that are scheduled to expire in September. H.R. 5651 passed the House by a vote of 387 to 5.
Cambridge Consultants on Thursday released a report outlining how the health-and-wellness market may take shape as more consumer-friendly medical devices featuring the latest in technology reach the market.
ROCKVILLE, Md. — The Food and Drug Administration on Monday announced that a consent decree of condemnation, forfeiture and permanent injunction has been filed against H&P Industries, Triad Group and three individuals, which would prevent them from manufacturing and distributing products from their Hartland, Wis., facility, or any other location.
Lansinoh Labs on Tuesday announced the acquisition of certain operational and manufacturing assets from En-Ko Electronic Control Systems in Izmir, Turkey. The acquisition will allow Lansinoh to directly control the manufacturing of the Lansinoh Affinity double electric breast pump, Lansinoh Affinity breast-milk storage bottles and Lansinoh ComfortFit flanges.