Devices
Three stakeholders have submitted information in response to an FDA renewed solicitation for public input on patient safety, including best practices to promote patient safety, education, and competency, associated with medical software functions that are excluded from the medical device definition in the 21st Century Cures Act. Wolters Kluwer cites
Devices
A 3/21-5/10 FDA inspection at a Criticare Technologies medical device operation in Warwick, RI, found that the patient monitors it manufactures, including the nGenuity patient vital signs monitor, are adulterated due to violations of the Quality System regulation. A 7/12 Warning Letter says specific violations were:
Devices
FDA has posted a Web page of frequently asked questions (FAQs) about its new final rule on laboratory-developed tests (LDTs). The post covers definitions and general oversight, phaseout policy and enforcement discretion policies, labeling, premarket review, investigational use, specific test categories or technologies, and resources and interactions with FDA.
Devices
FDA has cleared a Think Surgical 510(k) for its Tmini Miniature Robotic System with Tmini 1.1. software for total knee arthroplasty procedures. The device’s Tmini PRO workflow “enables positional refinement and optimization” of the implant tailored to a patient’s needs, the company says. “The workflow’s
Devices
FDA has granted Tulavi Therapeutics a de novo marketing authorization for its Allay Nerve Cap, described as a fully absorbable in situ forming hydrogel that is designed to protect transected nerves, prevent axonal escape, and reduce the risk of neuroma formation. When peripheral nerves are cut during amputation, they attempt
Devices
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Devices
Mainz Biomed has submitted an application requesting a breakthrough device designation for what it calls its non-invasive next-generation colorectal cancer test including the company’s portfolio of messenger (mRNA) biomarkers. The submission is based on data read-outs of its clinical studies ColoFuture and eAArly Detect, as well
Devices
FDA is announcing an 11/6 public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The workshop is intended for the agency to discuss the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to
Devices
FDA has cleared a Heidelberg Engineering 510(k) for its Spectralis optical coherence tomography angiography (OCTA) Module with SHIFT technology, which is claimed to reduce acquisition time by 50%. The preset OCTA speed of 125 kHz is designed to enhance clinical efficiencies and maintain image quality, the company says. “Combined
Devices
FDA has cleared a Globus Medical 510(k) for its ExcelsiusFlex with total knee arthroplasty option. The new robotic navigation platform is designed to offer surgeons control, resection accuracy, and procedural flexibility in total knee arthroplasty, according to the company. Additionally, it says Actify 3D Total Knee System for use
Devices
FDA has granted Restore Medical a breakthrough device designation for its ContraBand device and its use in treating heart failure with reduced ejection fraction (HFrEF) patients who remain symptomatic despite maximally tolerated guideline-directed medical therapy and who don’t have significant pulmonary hypertension or right heart failure. ContraBand is
Devices
FDA says it has issued two additional Warning Letters as part of its ongoing evaluation of plastic syringes made in China for potential medical device failures. Warning Letters were sent to Jiangsu Shenli Medical Production Co., Ltd. for quality system violations for syringe products, and to Jiangsu Caina Medical Co.
Devices
FDA says that Philips Respironics is updating instructions for using its OmniLab Advanced+ ventilator due to interruptions and/or loss of therapy. An agency notice says it considers this latest Philips correction a Class 1 recall. According to the notice, Philips issued an urgent recall notice for all affected customers
Devices
FDA has cleared a Subtle Medical 510(k) for its SubtleSYNTH, which uses deep learning to generate synthetic Short Tau Inversion Recovery (STIR) images from already-acquired T1 and T2 weighted contrasts. “SubtleSYNTH creates synthetic STIR images with zero acquisition time that are interchangeable with conventionally acquired STIR images,” the
Devices
Baxter International is recalling (Class 1) certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly due to reports of the handset plug disconnecting from the nebulizer port on the blue ventilator adapter. To date, there have been no reported injuries associated with the issue.
Devices
FDA has cleared a Hyperfine 510(k) for the ninth generation of artificial intelligence-powered Swoop system software. The software is designed to significantly reduce scan times across multiple magnetic resonance (MR) sequences without sacrificing image quality, the company says. “These scan time reductions may enable Swoop system images to
Biologics
FDA has published a guidance, Application User Fees for Combination Products, explaining how fees are assigned for combination products reviewed in a single application or separate applications for each component. The document says the guidance replaces one issued in 4/2005 to provide consistency with current user fee programs and
Devices
FDA has cleared a Smith+Nephew 510(k) for its new Catalystem Primary Hip System, which the company says is designed to address the increased adoption of anterior approach procedures and the expanding role of ambulatory surgery centers. “Advancements in primary hip arthroplasty include a shift to a shorter, proximally
Devices
CDRH is announcing new organizational changes to help the Center meet commitments under the Medical Device User Fee Amendments reauthorization and other strategic priorities. For example, CDRH is elevating the Office of Communication and Education into a super office called “Office of Communication, Information Disclosure, Training, and Education (OCITE)” and
Devices
Baxter is recalling (Class 1) its Life200 Ventilator System due to the potential for battery failure involving its charging dongle, which can prevent the system from charging or only allow for intermittent charging. “Use of affected products may cause serious adverse health consequences, including a drop in oxygen levels (desaturation
Devices
Former FDA commissioner Scott Gottlieb (2017-2019) says Congress needs to design a framework for the modern, efficient regulation of medical artificial intelligence that could be based on the regulatory scheme articulated in the pending Verifying Accurate Leading-edge IVCT Development Act (VALID Act — bills S 2209 and HR 4128)
Devices
Bausch+Lomb’s Synergetics unit is recalling (Class 1) its I-PACK Injection Kit with Drape, which is used for the administration of an intravitreal (back of the eye) injection, because sterilization certificates could not be validated by the supplier. The company sent an “Urgent Medical Device Voluntary Recall” notice