Devices
FDA is asking members of its General and Plastic Surgery Advisory Committee to comment on the risks and benefits of IceCure Medical’s ProSense cryoblation system intended to be used in patients with early-stage, low-risk breast cancer as an alternative to breast-conserving surgery (lumpectomy). A briefing paper
Drugs
In an NPR interview, FDA commissioner Robert Califf says the field of artificial intelligence will be so big that FDA couldn’t possibly hire enough people to regulate it alone. “It’s very important that we get the clinical community, the health systems, the professions, the people you see for
Devices
FDA has approved an Envoy Medical IDE for its pivotal study of the Acclaim Fully Implanted Cochlear Implant, an implanted sensor that the company says is designed to leverage the natural anatomy of the ear to capture sound. The agency approved the IDE application as a staged clinical study, which
Devices
FDA has cleared a SimBioSys 510(k) for TumorSight Viz to expand its use by breast surgeons by processing images using artificial intelligence (AI). According to the company, the AI processing delivers “accurate and efficient tumor and tissue segmentation, enabling detailed 3D spatial visualization to support treatment planning.” The digital
Biologics
Four stakeholders — St. Jude Children’s Research Hospital, the National Organization for Rare Disorders (NORD), the Muscular Dystrophy Association (MDA), and the Biotechnology Innovation Organization (BIO) — are voicing support for an FDA proposal to create an FDA Rare Disease Innovation Hub (RDI Hub). The four also respond to FDA questions
Devices
Attorney Bradley Thompson (Epstein Becker Green) says his review of the FDA consensus standards database indicates that CDRH “is not yet investing enough time and energy in recognizing standards to support digital health and the adoption of artificial intelligence.” Writing online in Health Law Advisor, Thompson also says he is
Devices
Percussionaire has recalled (Class 1) certain lots of its Phasitron 5 breathing circuits due to the unexpected presence of nickel coating on one of the circuit’s components. This “may react to combinations of saline mixed with albuterol and N-acetylcysteine causing both discoloration and the potential to aerosolize the
Biologics
Responding to an FDA request for comments on total lifecycle considerations for generative artificial intelligence-enabled medical devices, AstraZeneca says it is important that the agency use a risk-based approach to the regulation of artificial intelligence/machine learning (AI/ML). “Risk-based frameworks are an important regulatory tool used
Devices
GE HealthCare subsidiary Datex-Ohmeda is recalling (Class 1) its Giraffe OmniBed and Giraffe OmniBed CareStation to update their use instructions after receiving reports about the warmer heater doors becoming loose. “If doors become loose, a high-priority alarm goes off and canopy movement stops,” a recall notice says. “If
Devices
FDA has approved the removal of an imaging contraindication on Abbott’s FreeStyle Libre 2 and 3 continuous glucose monitoring systems, and they can now be worn during common imaging procedures, such as X-rays, CT scans and MRIs. “Previously, patients had to remove their sensors during these procedures, resulting
Devices
FDA is partnering with the Department of Veterans Affairs to test healthcare-related artificial intelligence (AI) tools. A Nextgov/FCW report says the AI testing lab “will be an asset for federal agencies and the private sector to be able to test applications of AI in a virtual lab environment
Devices
FDA says the restrictions on GE Healthcare EVair compressor use that were announced in response to a company 12/29/2023 urgent medical device correction noting a potential for elevated levels of formaldehyde, based on preliminary testing, no longer apply. A 10/29 agency notice says GE determined that the
Devices
FDA has cleared a Paragonix Technologies 510(k) for its transportable perfusion device KidneyVault and its use in kidney preservation. The company says the device uses “streamlined digital monitoring capabilities with portable hypothermic perfusion technology to protect donor kidneys during transport.” The device is intended to be used for the
Devices
FDA has granted Distalmotion a de novo marketing authorization for the Dexter Surgical Robot for adult inguinal hernia repair. The device is designed to “seamlessly integrate” into existing operating workflows, and compatible with current operating room equipment, according to the company. It offers single-use instruments and permits “direct and
Devices
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Devices
Kinova is recalling (Class 1 device correction) its Jaco assistive robotic arm due to an increased fire hazard if the outer coating of the arm has any damage and makes contact with an electrically powered wheelchair that has electrical leakage caused by modifications, damage, or malfunction. The device is intended
Devices
FDA has issued a safety alert recommending that healthcare providers not use BioZorb Markers and BioZorb LP Markers manufactured by Hologic. The alert is based on a company recall notice due to reports of serious adverse events occurring in patients who had the devices implanted in breast tissue. The devices
Devices
Smiths Medical is recalling (Class 1) specific lots of its BLUSelect, BLUgriggs, and BLUperc products due to a manufacturing defect that may cause the pilot balloon to disconnect from the tracheostomy inflation line. “If the pilot balloon used to inflate the tracheostomy cuff disconnects, pressure may not be maintained, which
Devices
FDA has approved Medtronic’s Affera Mapping and Ablation System with Sphere-9 Catheter, which it describes as a mapping and pulsed-field radiofrequency ablation catheter for treating persistent atrial fibrillation and cavotricuspid isthmus-dependent atrial flutter. The device was designed to address “procedural challenges faced by the electrophysiology community,
Devices
Baxter Healthcare is recalling (Class 1) its Life2000 ventilator to update the use instructions after finding that the device may fail to issue a “low gas pressure alarm” if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not connected to the ventilator and turned on before
Devices
Pfizer has submitted several pages of specific line-by-line comments in response to an FDA draft guidance on “incorporating voluntary patient preference information over the total product lifecycle.” Among its recommendations are: * revise the guidance title to reflect that it focuses on patient preference information relating to medical devices;
FDA Policy/General
FDA commissioner Robert Califf says FDA is “entering an era where we’re going to have to rethink everything we do because of the technology changes that we’re seeing, which affect every single industry that we’re dealing with.” As reported by Chief Healthcare Executive, Califf spoke to the