We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A position paper from the European Commission’s Medical Device Coordination Group (MDCG) proposes a list of actions aimed at easing the burden of notified bodies (NB) under the EU’s new regulations, including use of hybrid audits and evidence from previous assessments. Read More
Integra LifeSciences has issued a global recall of all its CereLink intracranial pressure (ICP) monitors due to customer reports of pressure readings that were out of range. Read More
Campbell, Calif.-based Imperative Care’s Zoom Stroke Solution proved safe and effective in treating distal vessel occlusions in ischemic stroke patients, according to study results presented at the World Federation of Interventional and Therapeutic Neuroradiology’s annual meeting in Tokyo this week. Read More
In a move to increase patient access to certain medical devices, the Centers for Medicare and Medicaid Services (CMS) said it plans to discontinue the use of two cumbersome medical device forms for claims with dates of service on or after Jan. 1, 2023. Read More
Event Medical did not properly investigate hundreds of complaints about failures in its ventilators, an FDA investigator observed in a Form 483 issued after a May 9-18 inspection of the company’s Irvine, Calif., facility. Read More
The Medical Device Innovation Consortium (MDIC) is moving ahead with plans to create a global, publicly available research library of somatic reference samples (SRS) — human cell lines containing important, cancer-causing mutations — for use in developing cancer diagnostic tests. Read More
Medical device recalls reached their highest level in two years during the second quarter of 2022 with 268 events, a 34 percent increase from the 200 recalls in the first quarter, according to Sedgwick, a company that specializes in product recalls and remediation. Read More
The FDA said it has received 44 more reports of deaths associated with the June 2021 recall of millions of Philips’s continuous positive airway pressure (CPAP), bi-level positive airway pressure (BiPAP) and ventilator devices.
The FDA has updated its guidance for manufacturers of in vitro diagnostic devices who want to use a previously cleared instrument assay, or replacement reagent, on another instrument, providing information on when and how to determine if a new 510(k) application is needed. Read More
Manufacturers should provide better information about specific risks and directions for use of hydrogen peroxide-based contact lens care products (HPCPs), the FDA said in a draft guidance released yesterday. Read More