EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart failure.
If Approved, Teprotumumab Would be the First FDA-Approved Medicine for this Vision-Threatening Disease
Representative Jim Struzzi (R-IN) introduced two new bills that have the potential to regulate cannabidiol (CBD) and kratom sales in Pennsylvania.
The FDA has issued new draft guidance for labeling of prescription medications that could be abused, with the goal of making the risks of dependence clearer for health care providers and for patients.
The Food and Drug Administration (FDA) has granted a submission for a Breakthrough Device designation from Prescient Metabiomics for its LifeKit Prevent Colorectal Neoplasia Test for the early detection of colon polyps and colon cancer.
Sofwave Medical Ltd., an emerging aesthetic device company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sofwave system. The Sofwave device is indicated for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles.
Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, has announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the JuggerStitch™ meniscal repair device.
The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners.
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Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce the launch of the ReDSTM PRO ("ReDSTM PRO") system, the next generation of lung fluid management technology for heart failure.
Gottlieb joins as Aetion advances real-world evidence for making drug development and commercialization more efficient
The most important technology to embrace the beauty industry in the past decade.
First RECELL System clinical trial in the U.S. focused on acute soft tissue injuries, defects, and reconstruction; study expected to commence within next 6 months
ResearchAndMarkets.com held a seminar in San Diego on Sept. 12 and 13 entitled, "Managing Your Complaints and Obstacles in Post-Market Requirements – Results from Top Medical Device Observations During an Inspection.”
The U.S. Food and Drug Administration (FDA) removed the alcohol contraindication from Addyi, the only FDA-approved treatment for pre-menopausal women for Hypoactive Sexual Desire Disorder (HSDD).
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The Trump administration’s move to ban certain flavors of e-cigarettes and vaping devices either goes too far or doesn’t go far enough, according to those on opposite sides of the debate.
FDA publishes draft guidance documents to provide device-specific performance criteria for the Safety and Performance Based Pathway
The U.S. Food and Drug Administration barred 485 shipments from entering the United States in August, according to FDA import records.
Rybelsus® represents an innovation in diabetes treatment by providing a GLP-1 receptor agonist in an oral formulation
Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can address this crisis
The Prescription Drug Pricing Reduction Act (PDPRA) is expected to work its way through Congress this fall.