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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
Baxter said users and facilities should “stop use of all WatchCare system accessories where possible until this functionality is temporarily disabled and while Baxter continues to work to determine the cause of this problem.” 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
Pancreatic cancer patients treated with ViewRay’s MRIdian ablative radiation technology had a one-year survival rate from diagnosis of 93.9 percent and no incidences of acute toxicity, according to study results reported at the annual meeting of the American Society for Radiation Oncology (ASTRO) in San Antonio, Texas, Oct. 24-27. Read More
The FDA grants the De Novo classification to devices for which there are no comparable products already on the market that meet the same clinical need. Read More