The U.S. Food and Drug Administration classified the recall of Abbott Laboratories’ CentriMag blood pumping system, following the death of a patient, as Class 1 or the most serious type of recall.
In seeking innovative players that could change pharma and healthcare, Med Ad News found the developer of an app that helps people determine what illnesses are in their neighborhoods; the creator of a wearable injector that allows patients on biologics to receive these drugs outside the clinic; and a designer of a deep learning network aimed at giving pharma and healthcare companies a handle on their data.
What are key trends in the transparency compliance landscape? And, how are life sciences manufacturers tackling growing requirements
Medical device maker Stryker Corp. will buy smaller rival Wright Medical Group for about $4 billion in cash, expanding into the fast-growing business of implants for shoulders and wrists.
EVERSANA, a leading independent provider of commercial services to the life science industry, announced an agreement to acquire Canada-based Cornerstone Research Group Inc.
U.S. state attorneys general said Johnson & Johnson and a company unit agreed to pay nearly $117 million to settle litigation over deceptive marketing of transvaginal surgical mesh devices.
Illumina Inc. and Qiagen N.V. announced a 15-year partnership intended to broaden the availability and use of NGS-based in-vitro diagnostic (IVD) kits, including companion diagnostics, for patient management.
Accelmed, a U.S.-Israel group of funds investing in medical device and digital health companies, is establishing a new fund with the aim of raising and managing $100 million.
A British court ruled in favor of Vectura Group and the company’s partner Sandoz over the packaging of a generic version of an inhaler made by bigger rival GlaxoSmithKline.
The U.S. Food and Drug Administration approved self-administration of AstraZeneca’s asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen.
Abbott announced approvals in Europe for two life-saving pediatric devices, the Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder.
Orchestra BioMed Inc., in partnership with Terumo Corporation, announced Breakthrough Device Designation was granted by the U.S. Food and Drug Administration for the biomedical innovation company’s Virtue Sirolimus-Eluting Balloon in the treatment of below-the-knee peripheral artery disease.