Devices
FDA has cleared a Median Technologies 510(k) for eyonis LCS, the first artificial intelligence (AI)–based device cleared for both detection and diagnosis in lung cancer screening. The software-as-a-medical-device is designed to help clinicians identify lung cancer at earlier, potentially curable stages while reducing false
Devices
Johnson & Johnson MedTech has recalled (Class 1) multiple versions of its Cerepak Detachable Coil System, which is manufactured by subsidiary Cerenovus, for treating intracranial aneurysms and other neurovascular conditions. An FDA recall notice says the devices are being removed from hospitals and other points of use after the manufacturer
Devices
FDA has published a guidance, Computer Software Assurance for Production and Quality Management System Software, to supplement an earlier guidance on General Principles of Software Validation. The new document contains recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or
Devices
A 10/20-10/30/2025 FDA inspection at the Flextronics America facility in Austin, TX, found Quality System Regulation violations in the firm’s manufacturing of a continuous glucose monitor. A 1/27 Warning Letter says the specific violations were: * failure to adequately ensure that when the results of
Devices
Three Hogan Lovells attorneys say FDA’s new medical device inspection protocol that aligns with the new Quality Management System Regulation will require device manufacturers to prepare for a significant operational and cultural transformation for undergoing, addressing, and responding to inspections and remote regulatory assessments. Writing in an online post,
Devices
FDA has classified Abbott Diabetes Care’s recall of certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus continuous glucose monitoring sensors as a Class I recall, the agency’s most serious designation, warning that continued use could cause serious injury or death. The recall involves specific lots of the
Devices
Former CDRH branch chief for diagnostic and surgical devices Morris Waxler, who was involved in the original approval of laser eye surgery (LASIK) and later a prominent critic of the procedure, has passed away at the age of 88 in a hospital in Madison, WI. His wife, Carolyn Zahn-Waxler,
Devices
An FDA review of records submitted at the agency’s request by Unomedical Device in Reynosa, Tamaulipas, Mexico, identified Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of infusion sets for subcutaneous insulin delivery in diabetic patients. A just-released 1/8 Warning Letter says
Devices
A 10/14-10/23/2025 FDA inspection at the Abbott Diabetes Care facility in Alameda, CA, found Quality System Regulation violations in the firm’s manufacturing of flash and continuous glucose monitoring systems. A 1/23 Warning Letter says the specific violations were: * failure to adequately establish and maintain
Devices
FDA has issued an early alert to warn clinicians about a potentially high-risk issue affecting certain Abiomed heart pump devices used to support patients with acute right heart failure. The alert, which applies to all Impella RP with SmartAssist and Impella RP Flex with SmartAssist devices, comes after Abiomed
Devices
FDA has issued Beta Bionics a Warning Letter following an inspection of the company’s Irvine, CA, facility conducted 6/2025, according to a company regulatory filing. The agency issued the letter 1/29 after reviewing the company’s responses to a Form 483 listing inspectional observations identified during the
Devices
A patient safety advocacy group has filed a citizen petition urging FDA to create a comprehensive public database of medical device labels, arguing that greater transparency is needed to support informed decision-making, research, and postmarket oversight. The petition asks the agency to publicly post all labels, labeling, and instructions
Devices
On 2/2, FDA is discontinuing the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850). FDA will also no longer use Inspection of Medical Device
Devices
Grail has submitted the final module of its PMA for the company’s multi-cancer early detection blood test. The Galleri test, which was designated a Breakthrough Device by FDA in 2018, is designed to detect cancer signals and predict their tissue of origin from a single blood draw. It
Devices
FDA has issued an updated guidance clarifying when clinical decision support (CDS) software functions fall outside the definition of a regulated medical device, offering developers greater insight into how the agency interprets its statutory authority over digital health tools. The document, Clinical Decision Support Software, which supersedes an identically titled
Devices
As part of its MDUFA 5 commitment to promote international harmonization and provide additional CDRH resources for that work, the Center conducts annual assessments of its international activities. The 2025 report lists the five strategies envisioned in the CDRH strategic plan on international harmonization: * increase engagements in international harmonization, convergence,
Devices
The CDRH 2025 Annual Report says the Center authorized 124 novel medical devices last year, including the first blood test to diagnose Alzheimer’s disease. The report says the number of authorizations was one of the highest in the Center’s more than 40-year history. Other accomplishments cited by
Devices
FDA’s recent issuance of Warning Letters to four direct-to-consumer testing companies over the use of unauthorized at-home blood collection devices underscores that self-collection kits remain subject to FDA oversight despite a recent court ruling that curtailed the agency’s authority over laboratory-developed tests (LDTs)
Devices
FDA has issued a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manufactured by its subsidiary, Magellan Diagnostics, underscoring an ongoing regulatory focus on the company’s LeadCare products. The 12/22 warning follows an FDA inspection conducted this past summer at Magellan’
Devices
FDA has issued MAST Biosurgery USA a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting violations related to the company’s SurgiWrap FROST surgical mesh products. The 12/17 letter says the inspection found that the products were adulterated under federal law because the company
Devices
FDA has approved Guardant Health’s Guardant360 CDx liquid biopsy as a companion diagnostic to identify patients with BRAF V600E–mutant metastatic colorectal cancer who may benefit from treatment with Pfizer’s Braftovi (encorafenib) in combination with cetuximab (Lilly’s Erbitux) and chemotherapy. The decision was supported by data from
Devices
FDA has issued a draft guidance laying out detailed expectations for how makers of cuffless, non-invasive blood pressure monitoring devices should test and validate their products before seeking market clearance. The document focuses on clinical performance testing for a fast-growing class of devices that estimate blood pressure without