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Medtronic is spinning off its patient monitoring and respiratory interventions businesses into a new, independent entity that has yet to be named. Read More
In an effort to accelerate drug and diagnostic advances in multiple sclerosis (MS), non-alcoholic fatty liver disease and other conditions, Quest Diagnostics and Decode Health are working on a national platform for gathering and storing trial participant specimens for future RNA analysis. Read More
The FDA aims to help industry prepare responses to deficiency letters by suggesting a standardized format, the agency said in a final guidance released yesterday. Read More
The FDA has requested that Accelerate Diagnostics discontinue marketing and distribution of its Accelerate Arc system and related blood culture kit as they are not Class I devices and therefore not exempt from 510(k) clearance. Read More
Sensoria Health and Padula Research Technologies (PRT) will be presenting details of NeurOpTrek and its sock sensor tool to assess the risk of falling at the American Academy of Optometry annual meeting in San Diego, Oct. 26-29. Read More
Although the FDA may initiate voluntary or mandatory product recalls, the most common method is a company-initiated voluntary recall, as described in 21 CFR §7.46. Read More
Cordis has acquired Switzerland-based MedAlliance and its Selution SLR (sustained limus release) drug-eluting balloon — an alternative to the paclitaxel-coated balloons that have raised concerns among regulators because of the risk to patients with peripheral arterial disease (PAD). Read More
The FDA issued Harmar Mobility a Form 483 for inadequate design validation procedures and other lapses observed at the company’s Lake Winnebago, Mo., facility during a July 11-15 inspection. Read More