Medical device companies are seeking to reduce product defects and increase patient safety with an industry-managed program that focuses on final product quality via oversight of the most critical manufacturing processes. Modeled on a 30-year-old aerospace industry program called Nadcap, Medaccred brings device manufacturers and suppliers together to define accreditation for special processes.
Cambridge, Mass., startup Enclear Therapies Inc. has secured $10 million in series A financing led by 20/20 Healthcare Partners. The company is developing a device to aid in treating amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases by removing toxic proteins from cerebrospinal fluid (CSF).
Medtronic plc, of Dublin, blamed dampened demand for heart devices ahead of new product launches for its third-quarter revenue miss. Fiscal 2020 Q3 revenue totaled $7.72 billion, below Wall Street’s estimate of $7.81 billion, for organic sales growth of 2.6% vs. consensus and guidance of 4% or higher.
Keeping you up to date on recent developments in diagnostics, including: Creating a safer MRI contrast agent; Novel blood test for HPV-related head and neck cancer; More enhancers suggest more pathogenicity: study; Distinguishing real from backseat drivers.
ANAHEIM, Calif. – Most medical device manufacturers follow a traditional, linear, task-driven approach for product development. Switching to a knowledge-driven approach, called agile-lean, may yield better results. That was the takeaway from a talk at MD&M West.
ANAHEIM, Calif. – Is artificial intelligence (AI) ready for prime time in health care? What’s hype and what’s real? That’s the question that was posed to an expert panel at MD&M West.
ANAHEIM, Calif. – The digital health wave is impacting seemingly every aspect of health care, from digital therapeutics where software is the therapy to powerful analytics that bring actionable insights to aid in a clinical situation.
Houston-based Nanospectra Biosciences Inc. has kicked off a pivotal U.S. study of its Aurolase therapy in the targeted destruction of prostate tumors using nanomedicine technology. The IDE study, with an estimated completion date of December 2022, will support a de novo 510(k) submission to the U.S. FDA. The first two patients were treated at the University of Michigan, which also participated in the first-in-human pilot study of Aurolase.
Keeping you up to date on recent developments in diagnostics, including: Raman spectroscopy to monitor blood glucose; A score to predict progressive chronic liver disease; From African genomes, big insights with small sample size.
Becton, Dickinson and Co. (BD) (NYSE:BDX) reported revenue of $4.23 billion for the first quarter of fiscal year 2020, ended Dec. 31, up 1.6% from the same period a year ago. Revenue grew 2.5% on a currency-neutral basis. However, an unexpected regulatory hurdle for its Alaris infusion pumps caused the Franklin Lakes, N.J.-based company to lower its 2020 revenue and earnings guidance. Despite the shadow cast by the Alaris news, BD beat Street expectations for the quarter – clocking in at $4.23 billion vs. $4.18 billion.
