As we celebrate more women becoming medtech leaders and paving the way for innovation, it's important to remember the many accomplishments women have already made when it comes to the advancement of health and medicine. X-rays on the battlefield, the American Red Cross, leprosy treatment and more -- these advances happened because of women. As we mark Women's History Month this March, go to Medical Design & Outsourcing to discover the stories of eight women who have made their mark on health and medicine.
Astellas Pharma's supplemental new drug application for Xtandi, or enzalutamide, to treat patients with nonmetastatic castration-resistant prostate cancer, was given priority review status by the FDA. The agency has set the action date for Xtandi for July.
The marketing application for pSivida's Durasert, which is being developed as a three-year treatment for patients with posterior segment uveitis, was accepted by the FDA for review. The agency has set the PDUFA date for Nov. 5.
Heron Therapeutics' HTX-011 reduced pain and allowed patients undergoing bunionectomy or hernia repair to avoid postoperative opioid pain drugs in two Phase III clinical trials, and the company plans to request FDA approval for the drug. The drug, which was injected at the surgical site and is comprised of bupivacaine with meloxicam, was superior to bupivacaine alone and to a placebo in both trials, the company says.
Natural Grocers suspended the production of and recalled its Coconut Smiles Organic coconut because of contamination with salmonella, which was linked to six reported illnesses. The recalled products, which were packed in 10-ounce bags with the UPC number 8034810, were sold to 145 stores in 19 states.
A study presented at the European Heart Rhythm Association's annual meeting showed use of Medtronic's Arctic Front Advance cryoballoon for treating atrial fibrillation demonstrated a 60.7% rate of freedom from atrial arrhythmias of at least 30 seconds, meeting the primary outcome of single-procedure success at one year. The device also showed a procedure-related complication rate of 4% for the 130-patient trial's secondary outcome, acute procedural success.
Edwards Lifesciences obtained de novo clearance from the FDA for its Acumen Hypotension Prediction Index, which has features for detecting potential hypotensive events, providing alerts when the hypotension prediction index exceeds an upper threshold and identifying the cause of low blood pressure. The software, designated as an adjunctive predictive cardiovascular indicator by the FDA, will be launched on a targeted basis.
Draft guidelines were released by India's Department of Pharmaceuticals to require domestically sourced components to account for 25% to 50% of the cost of medical devices, depending on product categories, before the technologies can qualify for procurement by the government. A domestic medtech group says the guidelines have no provisions to facilitate domestic industry growth, and international groups say the rules may not be possible to follow for high-end devices that cannot be manufactured in India.
A round of Series C funding pulled in $55 million for Unity Biotechnology, which develops candidates for age-related diseases. Unity's UBX0101 is anticipated to enter clinical study this half for osteoarthritis and its UBX1967 is in preclinical testing for diabetic retinopathy, diabetic macular edema, glaucoma and age-related macular degeneration.
Scientists working in a California-based USDA research lab are finding new ways to recycle the billions of pounds of almond waste produced by farmers throughout the state, including in biofuel, bio-based plastics, beer and cider. Scientists say they are also using the hulls to produce alternative sugars for feeding bees and as a possible replacement for high-fructose corn syrup.
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