With COVID-19 causing deferments of medical procedures worldwide, Johnson & Johnson beat Wall Street estimates for the second quarter of 2020, with better than expected performance in its medical device segment. Worldwide sales for the unit totaled $4.29 billion, down 32.5% year over year on an adjusted operational basis vs. the Street’s projected 47% decline. Read More
Diversified health care player Abbott Laboratories did better than expected when it reported second quarter earnings. The Abbott Park, Ill.-based company is one of the earliest to start reporting for this period, which in the U.S. was characterized by an initial heavy impact from the ongoing pandemic. Read More
The next phase of testing for the COVID-19 pandemic will hopefully include the roll-out of tests for neutralizing antibodies for the SARS-CoV-2 virus, but there are some roadblocks. The FDA’s Tim Stenzel said the agency has a limited amount of information to offer regarding emergency use authorizations for these tests, a predicament that might not resolve until several applicants are in and the agency can see some information that will aid in development of performance and validation standards. Read More
In its first fully virtual markup session, the House Energy and Commerce Committee Wednesday set aside politics to approve a bill that would make the U.S. Strategic National Stockpile (SNS) a better emergency resource – at least for the next few years. Read More
PARIS – Affluent Medical SA recently raised $17.8 million in new financing. This will be used to bring forward the clinical program for its minimally invasive implants, designed to restore physiological function in patients suffering from structural heart disease as well as urinary incontinence. Read More
Edwards Lifesciences Corp. has scored an approval from the U.S. FDA for the Konect Resilia aortic valved conduit, a ready-to-implant solution for bio-Bentall procedures. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3D Med, 7D Surgical, Abiomed, Invo Bioscience, M.I. Tech, Todos Medical. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Telemedicine Association, Heraeus, Zimmer Biomet. Read More
Keeping you up to date on recent developments in diagnostics, including: Predicting likelihood of rare disease; X chromosome is finished; Cotesting improves detection of cervical cancer; Single-cell studies give insights into pulmonary fibrosis. Read More