ALIVECOR: FDA Grants First-Ever Clearances to Detect Bradycardia and Tachycardia on a Personal ECG Device
KardiaMobile® Now The Only Personal ECG to Detect The Three Most Common Heart Arrhythmias
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BOSTON SCIENTIFIC CORPORATION: Receives FDA Approval for LOTUS Edge™ Aortic Valve System
Transcatheter Aortic Valve Replacement Technology for Patients with Severe Aortic Stenosis Designed to Minimize Paravalvular Leakage, Offer Controlled Delivery and Repositionability Post Deployment
Out-of-pocket drug costs a key voter concern, new poll finds
Lowering out-of-pocket costs for prescription drugs is among American voters’ top health concerns, a new poll by released by a drug company trade association concludes.
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ABBVIE: Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis
Approval based on clinical trials showing people treated with SKYRIZI™ (risankizumab-rzaa) every 12 weeks - four doses a year after two initial doses - achieved high levels of durable skin clearance at 16 weeks and maintained this response at one year[1-3]
NEUROSIGMA, INC.: Announces FDA Clearance of Monarch eTNS System as First Non-Drug Treatment for Pediatric ADHD
NeuroSigma, Inc., a Los Angeles-based bioelectronics company focused on commercializing Trigeminal Nerve Stimulation (TNS) technology for treating neurological and neuropsychiatric disorders announced that its Monarch® eTNS® System (Monarch) received FDA clearance as a non-drug treatment for attention deficit hyperactivity disorder (ADHD).
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for pediatric patients with lupus
The U.S. Food and Drug Administration approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus”
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves device to help increase access to more lungs for transplant
The U.S. Food and Drug Administration approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant.
'Stop doing these analyses,' Mercatus Center researcher says ahead of FDA benefit-risk public meeting
The U.S. Food and Drug administration's public meeting in May about the agency's human drug lifecycle benefit-risk activities has already attracted a recommendation from a regulatory and policy researcher: “stop doing these analyses.”
U.S. FOOD AND DRUG ADMINISTRATION: First FDA-approved vaccine for the prevention of dengue disease in endemic regions
The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas.
New campaign seeks to remove opioids from the home
The Food and Drug Administration is looking to women aged 35-64 to “Remove the Risk” of opioids in the household.
FDA moves to reduce risks associated with surgical staplers and implantable stables
The Medical Device Safety Action plan outlines the FDA’s mission to protect public health in a more timely and effective way.
IVANTIS, INC.: Announces Groundbreaking 3 Year Results from FDA Clinical Trial; First Device in Minimally Invasive Glaucoma Surgical (MIGS) Category to Demonstrate Significant Long Term Reduction of Severe Major Surgeries for Glaucoma Patients
First study of any kind showing a MIGS device achieving a statistically significant reduction in secondary incisional surgery; over 70% of patients remain free of medications
Clinical drug trial costs 'surprisingly low,' Johns Hopkins researchers find
Contrary to past drug company pronouncements, the cost of clinical trials makes up a small fraction of pharmaceutical drug development costs, a new study concludes.
CARIS LIFE SCIENCES: Receives FDA Breakthrough Device Designation for MI Transcriptome™ Companion Diagnostic Test
This is the first companion diagnostic to detect gene fusions across all solid tumors; Caris expects to submit for Pre-Market Approval later this year
INVITAE CORPORATION: New Study From Invitae Highlights the Importance of Multigene Genetic Testing for Uterine Cancer Patients
Results from one of the largest datasets in uterine cancer presented at The American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting
UPSHER-SMITH LABORATORIES, INC.: Unveils Educational Resources And Support Tools For Migraine Patients
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the launch of its newly redesigned website for Qudexy® XR (topiramate) Extended-Release Capsules.
ISAPS: Applauds U.S. FDA Allowance of Textured-Surface Breast Implant Sales
FDA announces new efforts to protect women's heath and ensure the safety of breast implants
U.S. FOOD AND DRUG ADMINISTRATION: Vaccination Is the Best Protection Against Measles
Measles is one of the most contagious respiratory diseases in the world that has the potential to be life-threatening.
U.S. FOOD AND DRUG ADMINISTRATION: Life Rising Corporation Recalls Chinese Herbal Supplements Because of Possible Health Risk
Life Rising Corporation of Willowbrook, IL is recalling Life Rising Holder-W Holder Warmer capsules, Life Rising NECK-ND Neck Clear capsules, and HoliCare Metabolism Cleansing (MET-CLS) tablets because the products have the potential to contain excessive levels of lead.
U.S. FOOD AND DRUG ADMINISTRATION: FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis
On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults.