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The FDA has deemed the Oct. 27 recall by Teleflex and subsidiary Arrow International of two central venous catheter kits as Class 1 because of the risk of serious injury or death. Read More
Oxford BioDynamics’ EpiSwitch blood biomarker assay for amyotrophic lateral sclerosis (ALS) showed which patients were likely to have a fast or slow progressing disease, the company said, citing interim results from a multicenter trial.
Pfizer has entered into a multi-year deal with Anumana — a joint venture between the Mayo Clinic and nference, an electronic health record data company — to develop software for early detection of cardiac amyloidosis.
Guardant Health’s investigational blood test to detect colorectal cancer in average-risk adults showed promising results in a 20,000-participant study evaluating what would be the first blood test available in the U.S. to scan for colorectal cancer.
To clear up any confusion about what the FDA considers delaying, denying, limiting, or refusing a drug or device inspection, the agency released a draft guidance on Thursday.
Patients who tested positive for peripheral artery disease (PAD) when screened using Selmer Scientific’s QuantaFlo in-home test showed significantly increased cardiac and adverse limb events in the follow-up period, according to a study reported in the peer-reviewed journal AJPM Focus. Read More
A federal court in California has dismissed all claims against RST-SANEXAS by Vanguard Clinic and several other plaintiffs about the company’s alleged misleading statements about insurance reimbursement for services for the company’s neoGen pain management devices.
The technology can enable surgeons to limit instrument movement based on a two-dimensional projection during surgery combined with pre-operative imaging.