Devices
FDA has issued an alert after becoming aware that Medtronic recently sent a letter to customers recommending that certain DLP Left Heart Vent Catheters be removed from where they are used or sold. Reports have been received about affected products resisting shape retention when being bent, according to the alert,
Devices
Thoratec has recalled (Class 1) its HeartMate Mobile Power Unit AC power cords due to unintended power disruptions. According to a just-posted recall notice, a misaligned V-Lock feature on the cords may cause an unintended disconnect. Customer advisory letters were recently sent stating that affected cords will be
Devices
FDA has granted de novo authorization for the ArteraAI Prostate test, the only artificial intelligence (AI)-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. A company statement says the authorization establishes a new product code category for future AI-powered digital pathology risk-
Devices
DeepSight Technology says it has received 510(k) clearance for its NeedleVue LC1 Ultrasound System, a device designed to deliver high-precision imaging for image-guided medical procedures. The device works by “leveraging” the company’s proprietary NeedleVue and OnPoint Imaging technologies to provide “real-time, highly accurate, ultrasound-based
Devices
A 9/10-9/13/2024 FDA inspection at the Spectra Therapy facility in Port Huron, MI, found multiple types of violations in the firm’s manufacturing of the LASERwrap system of therapeutic heating infrared lamps. A 7/22 Warning Letter says Quality System Regulation violations were: * failure to establish
Devices
Draeger is recalling (Class 1) its SafeStar and TwinStar breathing filters due to a risk of misleading carbon dioxide (CO₂) readings. The filters are used during anesthesia and mechanical ventilation to protect against bacterial and viral contamination. A recall notice says that misleading carbon dioxide readings could result in healthcare
FDA Policy/General
Infactory CEO Brooke Hartley Moy says she was not surprised when FDA’s internal artificial intelligence tool Elsa started producing fake research data. Interviewed for an online Cybernews report, Moy says AI models are still far from perfect and are known to hallucinate facts, oversimplify nuance, and generate confident nonsense.
Devices
Medical device manufacturers should be using FDA Warning Letters as a source of strategic intelligence that highlights recurring patterns, systemic gaps, and evolving priorities that can be used to strengthen compliance and drive operational excellence. That’s the view of “independent expert” Marcelo Trevino, writing in a MedDevice Online column.
Devices
FDA has approved Nyxoah’s Genio system, a hypoglossal nerve stimulation (HGNS) therapy for certain patients with moderate to severe obstructive sleep apnea. The device is intended for adults with an Apnea-Hypopnea Index (AHI) between 15 and 65 events per hour. The company says Genio offers HGNS treatment by
Devices
Becton Dickinson has recalled (Class 1 device correction) its BD Alaris Pump Module Model 8100 with Guardrails, Suite MX software versions, because the infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Devices
FDA has approved an Instylla PMA for its Embrace Hydrogel Embolic System (HES), a liquid embolic device for treating hypervascular tumors in peripheral arteries measuring 5 millimeters or less. Hypervascular tumors, which are commonly found in the liver, kidneys, bones, and other organs, are typically difficult to treat due to
Devices
A 2/24-2/27 FDA inspection at Visgeneer, Inc., in Hsinchu City, Taiwan, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of a glucose monitoring system and a blood uric acid monitoring system. A just-released 6/13 Warning Letter says the specific
Devices
FDA says the per- and polyfluoroalkyl substances (PFAS) used in medical devices are not the same as those identified as being potentially harmful to people in other contexts. An agency online post says the PFAS materials used in medical devices, known as fluoropolymers, have a long history of use. “FDA’
Devices
FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The agency has set a user fee
Devices
FDA has issued an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads with expanded polytetrafluoroethylene (ePTFE) coated coils that may impact shock efficacy or require early replacement. The leads are intended for pacing, rate-sensing, and delivery of cardioversion and defibrillation shocks
Devices
FDA has issued an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use instructions to prevent air embolism events. The devices are intended to provide vascular and transseptal access for the family of Watchman FLX Left Atrial Appendage Closure Devices with Delivery
Devices
FDA says it is aware that Medline ReNewal has told affected customers that certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters should be removed from where they are sold or used. An agency Early Alert says Medline ReNewal stated that specific lots of
Devices
A 2/24-2/27 FDA inspection at the Mectronic Medicale S.R.L. facility in Bergamo, Italy, identified Quality System, Medical Device Reporting, and other violations in the firm’s illegal manufacturing of adulterated and misbranded laser medical devices. A just-released 6/27 Warning Letter says the firm
Devices
Philips Respironics is recalling (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to the risk of failure involving the “Ventilator Inoperative” alarm, which can cause therapy interruption or loss. A recall notice says the devices may reboot intermittently, which could stop therapy,
Devices
Illumina has agreed to pay $9.8 million to settle allegations that it violated the False Claims Act by selling genomic sequencing systems with known cybersecurity vulnerabilities to U.S. government agencies. According to the Department of Justice (DoJ), between 2016 and 2023 Illumina allegedly sold sequencing systems to federal
Devices
Draeger has recalled (Class 1) its SafeStar 90 Plus bidirectional breathing system filter after receiving reports of slow increase of CO2-curve when a gas sample is taken from the filter’s sampling port, according to a recall notice. The filters are designed for infection prophylaxis during mechanical ventilation, particularly
Devices
Hamilton Medical has recalled (Class 1) its coaxial (1.8 m) breathing circuit set with flow sensor and expiratory valve that are used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators. The breathing circuit may have a crack in its blue tubing, which is used to deliver fresh gas