Devices
GE Healthcare’s Datex-Ohmeda unit has recalled (Class 1) 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 R860
Devices
Maquet Cardiovascular is recalling its Atrium Express Dry Suction Dry Seal Chest Drain in response to Nurse Assist LLC’s 11/2023 recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP due to sterility concerns. “If an Express chest drain is knocked over (device not
Devices
Two days after Philips Respironics announced a consent decree (see story) where it would stop marketing its troubled ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines, FDA is now announcing updated medical device reports and reports of death associated with the devices. According to the
Devices
CDRH director Jeffrey Shuren says the Center intends to start the reclassification process for most in vitro diagnostic medical devices (IVDs) from Class 3 (high risk) to Class 2 (moderate risk). In an online post, Shuren says that most of the tests to be reclassified are infectious disease and companion
Devices
Some 29 advocacy organizations are again calling on FDA to release a proposed ban on using electric skin shock devices to treat a person’s self-injurious or aggressive behavior. In a 1/23 letter circulated by the Autistic Self Advocacy Network, the groups say it has been eight years
Devices
Neuralink founder Elon Musk announced 1/29 that the company had implanted a chip in a human brain for the first time and that “initial results show promising neuron spike detection.” In a subsequent post on his social media platform X, Musk said Neuralink’s first product will be called
Drugs
The Department of Justice (DoJ) is looking at the use of artificial intelligence (AI) embedded in patient records that prompts doctors to recommend specific treatments. Bloomberg Law reports that department investigators want to learn more about generative technology’s role in facilitating anti-kickback and false claims violations. The newsletter
Devices
Philips Respironics says it has reached agreement with FDA on the terms of a consent decree over the company’s struggles to resolve issues surrounding its troubled ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. “Until the relevant requirements of the consent decree are met,
Devices
FDA has granted a de novo marketing authorization to Google and its new body temperature app on its latest Pixel 8 Pro smart phone. The app is part of the company’s January Pixel feature drop and it allows users to quickly scan a person’s forehead with the phone
Devices
FDA should identify and document specific changes it seeks to its statutory authorities that would enable it to take the actions it determines best to oversee artificial intelligence/machine learning (AI/ML)-enabled medical devices, a new Government Accountability Office report recommends. It says that once FDA has decided what
Devices
FDA has cleared an Envisionit Deep AI 510(k) for its artificial intelligence (AI)-assisted chest x-ray device, Radify Triage, for triaging pneumothorax and pleural effusion, which the company says are two critical findings that represent significant challenges in emergency rooms and intensive care units. “Radify showed significant clinical
Devices
CDRH says its Office of Strategic Partnerships and Technology Innovation (OST) has been elevated to a super office. The new designation allows the Center to be “well-positioned and capable of adapting to and addressing future public health needs and challenges while continuing to advance the voice of patients, innovation
Devices
FDA has granted Amadix a breakthrough device designation for PreveCol, a blood test for early detection of colorectal cancer. “PreveCol has demonstrated to have the potential to offer a great significant benefit to patients and has proven to have better diagnostic efficacy than currently approved colorectal cancer screening tests in
Devices
FDA has published a draft guidance, Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices, with recommendations for premarket submissions for orthopedic devices that contain metallic coatings and/or calcium phosphate coatings on the surface. The document says the recommendations reflect current review practices and are intended
Devices
FDA has released a draft guidance entitled “Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices.” The document provides recommendations for premarket submissions for orthopedic devices that contain metallic coatings or calcium phosphate coatings on the surface. They are intended to reflect current review practices and are
Devices
FDA has granted Bone Health Technologies a de novo marketing authorization for its Osteoboost, the first non-pharmacological device-based prescription treatment for postmenopausal women diagnosed with osteopenia (low bone density). The wearable belt is worn on the hips and delivers calibrated vibration to the lumbar spine and hips, the
Devices
FDA has cleared a Kallisio 510(k) for Stentra, a 3D-printed oral stent designed to protect healthy tissue in head and neck cancer patients. Customized for each patient, the device directs radiation to the target tumor area while reducing harmful impact to surrounding tissue, according to the company. “A
Devices
Federal Register notice: FDA is announcing a 2/13 meeting of its Medical Devices Advisory Committee’s Circulatory System Devices Panel. Panel members are scheduled to discuss and vote on an Abbott PMA for its TriClip G4 System, indicated for improving health status in patients with symptomatic severe tricuspid regurgitation
Devices
Globus Medical has recalled its ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit due to a calibration error. An FDA notice says the recall is attributed to the device’s design. “A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate
Devices
FDA has approved MRI labeling on Abbott’s dorsal root ganglion (DRG) stimulation therapy, the Proclaim DRG neurostimulation system, which allows patients to receive full-body MRI scans while the device is implanted. The device is intended to provide targeted relief for people with complex regional pain syndrome (CRPS) Types
Devices
In a joint 1/18 statement, CDRH director Jeff Shuren and Centers for Medicare & Medicaid Services (CMS) acting chief medical officer and acting director of the Center for Clinical Standards and Quality Dora Hughes say both agencies support an FDA 10/2023 proposed rulemaking to regulate laboratory-developed tests.
Drugs
Attorneys Chad Landmon and Aaron Savit (Axinn, Veltrop & Harkrider) say the Supreme Court heard oral arguments in two cases this week that appeared to signal the court is likely to restrict, if not eliminate, the so-called Chevron deference under which courts have given deference to executive branch agencies