Devices
Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz and attorney Allyson Mullen say FDA should follow its 2/20 letter to the medical device industry urging companies to be aware of issues with fraudulent laboratory data with “practical guidance to help firms establish and maintain data integrity
Devices
A 9/18-9/26/2023 FDA inspection at the Exactech facility in Gainesville, FL, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of orthopedic implants and accessories. A just-released 1/19 Warning Letter says specific violations were: * failing to adequately establish procedures
Devices
FDA has published a draft guidance, Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the Federal Food, Drug, and Cosmetic Act, to propose select updates to the guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. The draft document says the agency intends to
Devices
FDA and Instem researchers say their review of more than 10 million Medical Device Reports (MDRs) in the MAUDE (Manufacturer and User Facility Device Experience) database filed between 2011 and 2021 found that about 92% of reported issues represented medical device physical or functional failures rather than adverse events. Writing
Devices
Windstone Medical Packaging has recalled (Class 1) its Local Lower Extremity Pack, In-House Ocular Pack and Closure Kit in response to Nurse Assist’s 2023 ongoing recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to sterility concerns. The recalled kits contain Nurse
Devices
Abbott is recalling its HeartMate Touch System (version 1.0.32) due to the risk of an unexpected pump stop or start. “Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a ‘pump stop’ command is running,” a recall notice says. “When
Devices
FDA’s Medical Imaging Drugs Advisory Committee has voted 16-2 in support of approving a Lumicell NDA for Lumisight (pegulicianine), an optical imaging agent for use in patients with breast cancer. The combination product is intended for use with the Lumicell Direct Visualization System as an intracavity, fluorescence-guided
Devices
FDA has cleared a Getinge 510(k) for the Vasoview Hemopro 3, a third-generation endoscopic vessel harvesting (EVH) device. The Vasoview Hemopro is primarily indicated for patients undergoing EVH for arterial bypass. Its 7 mm extended length endoscope and dissection tip allows for visualization of a surgical cavity, dissection
Devices
FDA has classified as Class 1 a Medtronic Neurology recall of its Duet External Drainage and Monitoring System due to the potential for catheter disconnection from patient line stopcock connectors. The device is used to drain cerebrospinal fluid (CSF) to reduce intracranial pressure and CSF volume in people who have
Devices
Ventec Life Systems is recalling (Class 1) its VOCSN Patient Breathing Package due to a manufacturing issue that causes the bonded spiral wrap to detach before or during ventilation. “If the spiral wrap detaches, it can compromise the structural integrity, functionality, or cause blockage, stoppage, or leaks in the breathing
Drugs
FDA commissioner Robert Califf says he is concerned that the main use of artificial intelligence (AI) algorithms in healthcare will be “decisions that optimize the bottom line rather than optimizing the longevity and well-being of patients.” Speaking 3/5 to the Coalition for Health AI, of which FDA is
Devices
FDA has granted Quanterix a breakthrough device designation for its Simoa phospho-Tau 217 (p-Tau 217) blood test as an aid in diagnostically evaluating Alzheimer’s Disease (AD). The company says p-Tau 217 is a “top-performing biomarker” for AD pathology, noting that an Alzheimer’s Association working
Devices
An 8/15-9/7/2023 FDA inspection at the Fresenius Kabi USA facility in North Andover, MA, found Quality System and Medical Device Reporting violations in the facility’s work as a specification developer and manufacturer of the Ivenix Infusion System. A just-released 1/4 Warning Letter says
Drugs
The Parenteral Drug Association (PDA) says an FDA “Draft Report and Plan on Best Practices for Guidance” does not provide an overview and metrics on the initiatives in an agency 2011 good guidance practices report. PDA says it suggests that FDA include a section in the draft report with the
Devices
Smiths Medical ASD has recalled (device correction) its Medfusion model 3500 syringe pump due to software-related issues (before version 6). According to a Smiths recall notice, “Issues associated with earlier software versions of the medical pump include a high-priority alarm for delivery during motor not running, restarting infusion
Devices
FDA has cleared a Dexcom 510(k) for the company’s Stelo Glucose Biosensor System, which the agency says is the first over-the-counter continuous glucose monitor (CGM). The integrated CGM is intended for “anyone 18 years and older who does not use insulin, such as individuals with diabetes
Devices
FDA has approved a Boston Scientific PMA for the AGENT Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue. The paclitaxel-coated balloon catheter is designed
Devices
FDA has classified as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says it became aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE
Devices
FDA has updated a Class 1 recall (correction) of Megadyne Medical Products’ Mega Soft patient return electrode models. An agency notice says the recall was to update the instructions for use and product labeling to restrict the use of the device to patients aged 12 years and older. “Megadyne has
Devices
CDRH has posted an online statement updating its work in providing information to patients and providers about the safety risks of breast implants and regulatory actions involving implants and their removal. In the statement, CDRH Office of Surgical and Infection Control Devices director Binita Ashar cites a recent article in
Devices
FDA says it has received reports of adverse events associated with electrical operating room tables, including problems with positioning or unintended movement of the table that may result in serious patient injury, or extended or delayed surgical procedures that can lead to potentially life-threatening complications. “While FDA believes that
Devices
Wipro GE Healthcare Private Ltd. is recalling (Class 1) its Care Plus and Lullaby Incubators due to the device’s bedside panel or porthole not properly latching closed. “If a bedside panel or porthole is not latched properly, the panel can detach and open, no longer protecting the patient from