Abbott Laboratories said its newly launched glucose monitoring device would be covered by the Centers for Medicare & Medicaid Services, expanding its usage to millions of diabetes patients in the United States.
What are key trends in the transparency compliance landscape? And, how are life sciences manufacturers tackling growing requirements
The U.S. Food and Drug Administration issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valve.
People with chronic obstructive pulmonary disease (COPD) who use long-acting inhaled bronchodilators may have an increased risk of heart attacks and strokes right after they start taking these medicines, a Taiwanese study suggests.
Todd Campbell, writing for The Motley Fool, notes four biopharma stocks that topped out in the S&P 500 in 2017.
Anika Therapeutics Inc. announced that its HA-based bone void filler received 510(k) clearance from the U.S. FDA and is indicated for filling bone voids or defects of the skeletal system, which are not intrinsic to the stability of the bone, created during surgery or resulting from traumatic injury.
The U.S. Food and Drug Administration said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems.
Medtronic Plc agreed to pay $12 million to resolve claims that the company engaged in a deceptive marketing strategy to promote its Infuse bone graft product used in spinal surgery, the Massachusetts attorney general said.
U.S. House Republicans proposed to delay or suspend several taxes under former President Barack Obama’s healthcare law, including a tax on medical devices and the so-called “Cadillac” tax on generous health insurance plans.
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.
AliveCor today announced FDA clearance of KardiaBand in the U.S., allowing Apple Watch users to discreetly capture their EKG anytime and anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia.
Cochlear Limited received U.S. Food and Drug Administration approval for the first remote feature to allow follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform.
FDA approves first implanted lens that can be adjusted after cataract surgery to improve vision without eyeglasses in some patients
The U.S. Food and Drug Administration approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens’ power after cataract surgery so that the patient will have better vision when not using glasses.
The U.S. Food and Drug Administration approved the first two-drug regimen to treat HIV, aimed at lessening the side effect burden of current treatments that combine three or four medicines.
A federal jury in Dallas ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implants.
Shares of Merit Medical Systems jumped more than 9 percent after the company announced it plunked down $100 million for two product lines belonging to Becton, Dickinson and Company (BD).
The European Commission approved GlaxoSmithKline’s three-in-one inhaler Trelegy Ellipta for chronic lung disease.
The FDA approved an electrical nerve stimulator designed to reduce the symptoms of opioid withdrawal.
U.S. regulators approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.
Less than one month after announcing plans for construction of a South Carolina manufacturing facility, surgical solutions firm Arthrex announced the company’s plans for the expansion of its global headquarters in Florida.
Philips expects sales to grow by 4-to-6 percent in the coming three years as the Dutch company focuses on growth in the health technology market.