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Patients with herniated discs enjoyed considerable pain relief after surgery using Hoogland Spine Products’ MaxMoreSpine endoscopic system, the company reported, citing a study by researchers in the Netherlands and the New York-Presbyterian Weill Cornell Brain and Spine Institute in New York. Read More
High-risk “class D” in vitro diagnostics (IVDs) should get specialized handling from their manufacturers and the third-party notified bodies authorized to approve them on behalf of the EU, said the Medical Device Coordination Group (MDCG), which is made up of experts appointed by EU member states. Read More
The fifth most cited problem that the FDA encounters during inspections is process validation. Process validation is conducted on production equipment and is intended to confirm what you already know about how that equipment works. Validation is specific to the equipment, process and production, and should identify and control critical raw material and process parameters. The firm must complete this before the final design transfer and it should be a part of the design history file or DHF. Read More
Medical diagnostic test developer Cleveland Diagnostics has received a Form 483 for deficiencies observed during an FDA inspection of the company’s facility in Cleveland, Ohio, last November. Read More
The best way for Congress to help the FDA address its concerns about reports of a high level of false-positive results from noninvasive prenatal testing (NIPT) is to pass new legislation, the FDA said in a Feb. 11 letter to lawmakers. Read More
San Francisco, Calif.-based Sirona Medical has acquired two FDA-cleared products from Nines, another California radiology software developer, expanding its portfolio of products that use artificial intelligence (AI) for analysis of radiographic images. Read More
The FDA has released its long-awaited proposed rule that aims to harmonize the agency’s Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485 standard. Read More