Dexcom is using the soon-to-be released Apple Watch for its wearable glucose monitor. The Apple Watch showing a heartbeat. (Image courtesy of Apple) Nancy Crotti In the highly competitive, continuous-glucose-monitoring device ...
Tags: Apple Tech, Diabetes Tech
Salamtex, a textile manufacturing company in Egypt, has created a groundbreaking anti-microbial textile named ‘Guard Textiles’ providing protection against the transmission of infection in health care facilities, according to ...
Tags: Anti-Microbial Fabric, textile
Not so fast, Wright and Tornier. U.S. regulatory agencies want a few matters cleared up before deciding whether to approve the proposed $3.3 billion merger of U.S. bone-implant maker Wright Medical Group Inc. with Dutch orthopedic ...
Tags: orthopedic device, medical device
US President Barack Obama has proposed the establishment of a single food safety agency that will consolidate the responsibilities of the Food and Drug Administration, Food Safety Inspection Service, and other related agencies. Proposed ...
Tags: Food Safety, FDA
In America, the FDA’s current position is that BPA is safe at the current levels occurring in foods. In 2014, FDA experts from across the agency, specialising in toxicology, analytical chemistry, endocrinology, epidemiology, and other ...
Tags: toxicology, analytical chemistry, endocrinology, Agriculture
Seattle-based Lime Green Grocer has issued a recall for 783 individually wrapped Thai Delight Burritos, as it may contain undeclared soy. People who are allergic or severely sensitive to soy run the risk of serious or life-threatening ...
Tags: soy, Agriculture
The Nevro Senza, as shown in a video on the company's website. Nevro’s stock is now up more than 20% from where it was late last week, after the Menlo Park, CA–based company said that the FDA has deemed the PMA for its spinal ...
Tags: spinal pain-killing device, Health
Bosch Packaging Technology has expanded its portfolio for the serialisation of pharmaceutical packaging to help drug manufacturers comply with potential legislation changes about to be introduced by governments round the globe in the fight ...
Posted in Regulatory and Compliance by Nancy Crotti on January 21, 2015 Just in time for the next wave of wearable wellness devices appears ready to roll, FDA has issued guidance statements about wellness products and medtech accessories. ...
Tags: type 2 diabetes, heart disease, high blood pressure, Health
Ever So Saucy Foods by Chef Frank, the new brand of handmade, all natural and tradition-inspired fine prepared food line, will debut on QVC. The broadcast will represent the brand's national launch with the network. Ever So Saucy fine ...
Tags: Cheese, tomatoes, Agriculture
The theme of Gregory Conley’s latest article on Washington Times is the call for sensible ecig regulations. Conley, who is the president of American Vaping Association, likewise justifies the need for such policies in this piece. ...
The EnterMedics Maestro Rechargeable System weight loss treatment device is effective although scientists are unclear why. The FDA has approved the first weight-loss device since 2007, giving obese adults an alternative to dieting and ...
Nearly half of all Phase III pharmaceutical clinical trials fail, partly because data about patient adherence is hard to come by. That’s according to computer giant Oracle (ORCL), which has teamed with and ingestible sensor ...
Tags: self-reporting, lab tests, Health
US federal officials have found a link between strains of Listeria bacteria found in a California apple processing plant and the ones responsible for an outbreak that took lives of seven people and left several people sick in 2014. ...
The FDA won’t let 23andMe sell its Personal Genomic Service tests to consumers in the United States, but that hasn’t stopped the company from selling its customers’ anonymous information to other companies for research. ...