Devices
Draeger Medical has recalled (Class 1) its Draeger Perseus A500 Anesthesia Workstation due to the potential for an unexpected shutdown while operating on battery power. Last month, the company sent consignees an urgent medical device recall notification about the problem and the possible loss of ventilation if a shutdown occurred,
Devices
FDA has cleared a Cochlear 510(k) to lower the patient age for its Cochlear Osia System from 12 years to five years for children with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness. The bone conduction hearing device uses digital piezoelectric stimulation to bypass damaged areas
Devices
The Advanced Medical Technology Association (AdvaMed) says FDA’s draft guidance on “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials” needs to address what sponsors should do in the case of persons who choose not to identify race or ethnicity or those
Devices
Philips Respironics has recalled (Class 1) its Trilogy Evo ventilator and all software versions, except 1.05.06.00, due to the device’s potential for sudden loss of ventilation due to “battery depleted” or “loss of power” alarms while the unit has sufficient power. A recall notice says a
Devices
CDRH has released two reports on medical device safety and innovation. The reports have summaries of the Center’s accomplishments and planned initiatives for the future. They say that over a decade ago CDRH established a new vision for the Center based on the pillars of safety and innovation. “We
Devices
Boston Scientific is recalling (Class 1) its embolic agent Obsidio Embolic by issuing a correction after an investigation determined that delivery of the device using the aliquot technique, a commonly used delivery method in embolization procedures, for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. To date,
Devices
Sen. Bill Cassidy (R-LA) is calling on FDA to justify its decision to expand its oversight over clinical decision support (CDS) software beyond its statutory authority. In a letter to FDA commissioner Robert Califf, Cassidy says the agency’s 9/2022 final guidance that seeks to regulate CDS as
Devices
Fresenius Kabi USA has recalled its Ivenix Infusion System’s pump software due to a necessary software update. “The reason for the recall is that multiple software anomalies were occurring that have the potential to result in serious patient harm or death,” a recall notice says. “To remedy this issue,
Devices
FDA says it has learned that Soulaire Corp. in Santa Monica, CA, is marketing an external counter-pulsating device in the U.S. without marketing clearance or approval. A just-released 1/29 Warning Letter says the device is intended to treat chronic stable angina that is refractory to optimal
Devices
Former Decision Diagnostics CEO Keith Berman has been sentenced to seven years in prison for a securities fraud scheme involving a Covid-targeting medical device that he claimed was on the verge of being approved by FDA, but in reality did not exist. The scheme resulted in about $28 million
Devices
FDA has approved an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation. The “capacitively coupled” device emits a low-energy signal that has been clinically proven to promote bone healing after spinal fusion surgery, according to the company. It is designed to prioritize patient ease of
Devices
CDRH says it has launched a new public dataset to help chemistry labs ensure the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. A statement from CDRH director Jeffrey Shuren says the dataset “will allow analytical chemistry labs to determine their ability to detect a
Devices
FDA has cleared a 3D Systems 510(k) for its 3D-printed, patient-specific cranial implant VSP PEEK Cranial Implant, which is intended for cranioplasty procedures to restore defects in the skull. The device includes a “complete FDA-cleared workflow comprising segmentation and 3D modeling software, the 3D Systems EXT
Devices
Abbott’s Thoratec unit is recalling (Class 1) its HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due to an issue called extrinsic outflow graft obstruction. The condition occurs when “biological material builds up between the HeartMate outflow graft and the outflow graft bend relief or additional components
Devices
Fresenius Kabi USA has recalled (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that have the potential to cause underdose, overdose, or a delay in therapy, which could lead to serious patient harm or death, according to an agency recall notice. The
Devices
FDA has granted 16 Bit Inc. a de novo marketing authorization for Rho, an AI-enabled software device aimed at improving osteoporosis screening. The device was given a breakthrough device designation in 2021 as the first FDA-recognized radiology software for opportunistic evaluation of low bone mineral density (BMD), according
Devices
FDA has given a breakthrough device designation to Roche’s Elecsys pTau217 plasma biomarker test that it is developing with Lilly to aid healthcare providers in identifying amyloid pathology, a feature of Alzheimer’s disease. A Roche statement describes pTau217 as a phosphorylated fragment of the protein tau that is
Devices
FDA has cleared a Neurovalens 510(k) for the Modius Stress and its use to treat generalized anxiety disorder (GAD). The prescription device is designed to treat anxiety by delivering a small electrical pulse to the head for 30 minutes before bed, during which users can do other activities, such
Devices
FDA has cleared a U.S. Army Biotechnology High Performance Computing Software Applications Institute 510(k) for an artificial intelligence-powered smartphone application (APPRAISE-HRI) that uses vital-sign data from trauma patients to assess their risk of hemorrhage. The clearance will permit the Army’s Medical Research and Development
Drugs
A new report from the National Academies of Sciences, Engineering, and Medicine calls on FDA, HHS, the National Institutes of Health, and Congress to act to improve the inclusion of pregnant and lactating women in clinical trials. The document says such women are often excluded from clinical trials due to
Devices
In the latest move by FDA in its ongoing investigation into the quality of syringes made in China, the agency is announcing expanded actions against Jiangsu Shenli Medical Production Co. Ltd. with an additional import alert for not meeting device quality system requirements. The import alert is intended to prevent
Devices
Ten members of an FDA advisory committee evaluating an Abbott heart device had financial ties to the company, according to a KFF Health News report carried by NBC. The media outlet used the federal government’s Open Payments database to find that one committee member was linked to hundreds of