NinePoint Medical, Inc., a transformative medical device company pioneering the use of a real-time optical imaging platform for gastrointestinal applications, announced that it has received U.S. Food and Drug Administration (FDA) clearance to market the NvisionVLE® Imaging System for use in the pancreas and bile duct.
People afflicted with the deadly and crushing disease amyotrophic lateral sclerosis (ALS) are searching for some glimmer of hope in the shadow of promising drug treatments, however ALS patients do not currently have real access to these drugs, which are presently in trials.
NeuroVive Pharmaceutical AB (Nasdaq Stockholm: NVP) (OTCQX: NEVPF) announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.
Latest QTbreasthealth center now open within Scottsdale's Vincere Cancer Center, defining a new generation of breast imaging for women
Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that it has received clearance from the U.S. Food and Drug Administration ("FDA") to clinically investigate LPCN 1144 in an expanded target population of adult male non-alcoholic steatohepatitis ("NASH") patients.
Company Plans to Advance Pacritinib 200 mg Twice-Daily (BID) Dose to Phase 3 for Patients With Severe Thrombocytopenia
FDA grants crizanlizumab Priority Review based on Phase II data showing prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease, shortening FDA review to six months from standard ten months
The U.S. Food and Drug Administration is warning patients and health care providers that certain Medtronic MiniMed insulin pumps are being recalled due to potential cybersecurity risks and recommends that patients using these models switch their insulin pump to models that are better equipped to protect against these potential risks.
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BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting related to the potential increase in mortality associated with the use of paclitaxel-coated devices in patients with peripheral arterial disease (PAD) in the superficial femoropopliteal artery (SFA
WASHINGTON, D.C. -- A physician has applauded a new FDA program that aims to simplify the process doctors use to offer non-approved cancer treatments to patients.
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CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, announced FDA 510(k) clearance for the Cor™ PATCH. The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients.
Illinois’ Cook County is the U.S. jurisdiction most at risk of a measles outbreak this year, according to a study published this month in the British medical journal The Lancet Infectious Diseases.
New Labeling Reports Results of Post-Marketing Study Demonstrating Safety, Efficacy and Tolerability in Pediatric Patients
The number of U.S. measles cases confirmed this year reached 839 as of May 10, the highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.
US physicians and patient advocacy organizations expressed their overwhelming support for the FDA's suffix-based naming system for biologic medicines and biosimilars, according to comments electronically submitted last week to the agency.
The number of U.S. measles cases confirmed this year as of April 4 reached 465, the second-highest level for any year since the nation declared the disease eliminated in 2000, according to the Centers for Disease Control and Prevention.
