Devices
FDA has issued a safety alert about illegal use of injectable silicone for body contouring and associated injuries and disfigurement that can result from such products. The agency says the injectable silicone products are being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of
Devices
CDRH associate director for science and strategic partnerships Suzanne Schwartz says medical device manufacturers have made “a fair amount of progress that has been very encouraging” in dealing with cybersecurity issues. In an audio interview with the Information Security Media Group, Schwartz says the agency has seen industry be “more
Devices
FDA has cleared a Clinical Genomics and Quest Diagnostics 510(k) for its InSure One, an at-home collection, fecal immunochemical test intended to detect blood in stool. The device detects human hemoglobin in fecal samples to aid in identifying lower gastrointestinal bleeding. It requires sample collection from one bowel
Devices
FDA has cleared a Lensar 510(k) for its IntelliAxis-L, the company’s latest astigmatism management feature to guide toric intraocular lens (IOL) alignment in cataract surgery procedures. This feature for the femtosecond laser platform provides “intraoperative imaging to precisely and permanently identify the location of the steep corneal
Devices
FDA says it is no longer adding new adverse event codes for Medical Device Reporting (MDR) in response to device manufacturer requests. As part of an adverse event harmonization effort with the International Medical Device Regulators Forum (IMDRF), FDA expects to transition to the new coding as new annexes from
Devices
FDA has cleared a DT MedTech 510(k) for its Hintermann Series H2 Total Ankle Replacement System. The semi-constrained, total ankle replacement prosthesis is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis, primary arthritis
Drugs
Stericycle Expert Solutions says that medical device recalls fell 39% to 167 in the third quarter of 2017. It was the lowest quarter for the industry since the fourth quarter of 2011. Despite the steep drop, however, the group says, recalled units increased 1% to 68 million. “The main reason
Devices
A 9/18-10/16/14 FDA inspection found objectionable conditions at a clinical site operated by Dr. William Domb in Upland, CA, who was sponsor/investigator of the significant risk clinical study entitled “Expectations for IRB Research Associations and Oxygen/Ozone Simplified and Suggested Research Treatment Protocols: A Historical
Devices
Medical journal editors should encourage authors to disclose CDRH’s role in clinical trial design and execution and to discuss pivotal trial results within the context of regulatory approval, according to an 11/7 JAMA viewpoint piece. “Such policies will increase transparency and understanding of the regulatory approval process and
Devices
FDA wants to implement a novel regulatory approach for direct-to-consumer genetic health risk (GHR) tests that will use “flexible” oversight similar to the model used for digital health technologies (see earlier story). The agency is issuing a Federal Register notice 11/7 proposing to allow GHR tests to
Devices
CDRH Office of Compliance director Robin Newman has left the agency to pursue an undisclosed opportunity. She joined the Center 2/2016 after leaving Siemens Healthcare Diagnostics as its quality management vice president. Newman has over 20 years of senior level clinical/regulatory and compliance management in new product research
Devices
FDA has cleared a Medacta International 510(k) for its 3DMetal Tibial Cones for knee revision surgery. The device is used for structural support in areas of bone deficiencies that may compromise revision implant fixation, and are indicated for use with Medacta’s GMK Revision and GMK Hinge Knee systems,
Devices
FDA has cleared an IntraFuse 510(k) for its FlexThread Fibula Pin System that is intended to provide percutaneous fixation of distal fibula fractures, primarily Danis-Weber B type fractures, or trans-syndesmotic fractures. “Incorporating IntraFuse's proprietary FlexThread technology, the distal end of the implant is a flexible,
Devices
Abbott Quality & Regulatory says a draft FDA guidance on “Deciding When to Submit a 510(k) to an Existing Device” interprets a “major change in intended use” to be a type of change that “could significantly affect safety or effectiveness,” which is inconsistent with current regulatory language. In its
Devices
During a recent FDA Webinar on an agency final guidance on design considerations and premarket submission requirements for interoperable medical devices, CDRH senior science health advisor Heather Agler said the agency suggests that companies design systems with interoperability as an objective. “Think about this upfront when you’re thinking about
Devices
A Massachusetts federal judge has entered a consent decree of permanent injunction sought by FDA against Philips North America and two of its officers, generally prohibiting them from manufacturing, processing, packing, holding, or distributing medical devices made by the firm’s Emergency Care and Resuscitation (ECR) business unit at facilities
Devices
The 510(k) Coalition says in a comment letter that an FDA draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device,” exemplifies a strong step forward in clarifying and defining the process for when a modification would trigger a new 510(k)
Devices
An FDA safety update says that interim study results through three years from a pivotal clinical trial (ABSORB III) continue to show an increased rate of major adverse cardiac events and scaffold thrombosis in patients receiving Abbott Vascular’s Absorb GT1 Bioresorbable Vascular Scaffold (BVS), when compared to patients treated
Devices
CDRH associate director for science and strategic partnerships Suzanne Schwartz says the agency is encouraging medical device manufacturers to proactively update and patch their devices in a safe and timely manner to address cybersecurity threats. Writing in an FDA Voice blog post, Schwartz says the “concept of updates and patches,
Devices
FDA has cleared an Abbott 510(k) for its Alinity ci-series instruments for clinical chemistry and immunoassay diagnostics. The company says the devices are designed to help labs address modern industry challenges, including aging populations and growing management of chronic diseases and increased access to care, which are driving
Devices
Following Internet blog reports that Bayer has enrolled only one patient of the 2,400 needed for a post-marketing study of its controversial Essure birth control device, three House members led by Rep. Rosa DeLauro (D-CT) have asked for a meeting with FDA commissioner Scott Gottlieb to express
Devices
FDA has cleared a Butterfly Network 510(k) for what the sponsor describes as the world’s first “ultrasound-on-a-chip” based imaging system, the Butterfly iQ for the iPhone. The clearance covers 13 clinical applications, the “broadest ever for a single ultrasound transducer,” the company says. “By combining