Devices
FDA has granted Cala Health a breakthrough device designation for its Cala Trio targeted therapy for treating action tremors in the hands of adults with Parkinson’s disease. Cala Trio is currently FDA-cleared to relieve hand tremors from essential tremor. The company expects to begin clinical trials evaluating the
Devices
FDA has cleared a Tyber Medical 501(k) for its new line of foot and ankle plating systems. The clearance covers over 42 different indication-specific anatomical plating types, the company says, which are indicated to treat a range of deformity, trauma, and degenerative conditions to the forefoot, midfoot, rearfoot,
Devices
FDA has asked Helius Medical Technologies for more information to support its request for de novo classification and clearance of the Portable Neuromodulation Stimulator device as a potential treatment for gait deficit due to symptoms of multiple sclerosis, intended to be used as an adjunct to a supervised therapeutic exercise
Drugs
The Office of Management and Budget (OMB) has given federal agencies until 11/26 to issue final rules needed to implement a 5/19 executive order setting forth 10 principles of fairness that agencies are to consider in administrative enforcement and adjudication actions. The order was issued to help promote
Devices
FDA has cleared an Ezra 510(k) for its artificial intelligence (AI) and its use in assisting radiologists in their analysis of prostate MRI scans. The device is intended to provide accurate prostate volume measurements, semi-automatic lesion measurements, and automatic prostate and lesion segmentation and 3D volume representation. Should
Devices
FDA’s Medical Device Development Tools program has listed an agency-qualified tool that medical device sponsors can use in developing and evaluating medical devices that pose a cybersecurity concern. The tool is a rubric for applying a common vulnerability scoring system to medical devices. FDA says the rubric is
Devices
FDA is seeking feedback on a discussion paper entitled Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework. The paper provides best practices to consider when communicating with patients and caregivers about cybersecurity vulnerabilities. Feedback on the discussion paper, according to the agency, will help inform future efforts designed to
Devices
FDA has cleared an Ossio 510(k) for its Ossiofiber Compression Screw Portfolio for alignment maintenance and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis and bone grafts of the upper extremity, fibula, knee, ankle and foot. The devices comprise a 4.0mm-diameter cannulated, headless, partially threaded compression
Devices
CDRH has released a list of prioritized guidance documents that it intends to publish this fiscal year (FY 2021). Final guidance topics the Center intends to publish include Surgical Staplers, Safer Technologies Program for Medical Devices, Clinical Decision Support Software, Device-Specific Criteria Guidance for Safety and Performance Based Pathway
Devices
CDRH has released a series of videos highlighting the progress the Center has made to date with implementing the current medical device user fee program. The program has just ended its third year, and the videos include performance goals met, building CDRH’s total product lifecycle regulatory approach, accessing and
Devices
University of Oxford researchers say their review of comments on a proposed FDA regulatory framework for modifications to artificial intelligence and machine learning-based software as a medical device found that 63% of the comments came from parties with financial ties to industry and 86% of comments did not cite
FDA Policy/General
The Justice Department says Merit Medical Systems, South Jordan, UT, has agreed to pay $18 million to resolve allegations that it caused the submission of false claims to government healthcare programs by paying kickbacks to doctors and hospitals to induce use of its products. A department statement says the company
Devices
FDA has cleared a Livmor 510(k) for the Livmor Halo AF Detection System, a physician-prescribed wearable device that provides continuous monitoring of pulse rhythms for the detection of atrial fibrillation (AF), on demand during the day and automatically overnight. Continuous monitoring can significantly enhance the detection of paroxysmal
Devices
FDA has made available a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices. The document provides recommendations on testing for interference by biotin on the performance of in vitro diagnostic devices. It is intended to help device developers and clinicians understand how the agency recommends biotin
Devices
CDRH has released a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin. The document proposes select updates to FDA’s current thinking on the type of biocompatibility information that should be provided in a premarket submission for certain devices made from common polymers
Devices
FDA has published a guidance, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol, with the agency’s current thinking on technical considerations specific to devices using nitinol due to its unique properties. The document says nitinol is commonly used in the medical device industry. Device manufacturers have
Devices
FDA has issued an immediately-in-effect guidance, Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency, to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of
Devices
Researchers from Yale University and the University of California San Francisco say that FDA could ensure that better evidence is generated to guide clinical decision-making by requiring that medical devices cleared through the de novo pathway meet prespecified effectiveness endpoints for clearance. They also say that postmarket studies should
Devices
FDA has cleared an ImmersiveTouch 510(k) for its ImmersiveView Surgical Plan digital surgery platform that is intended to assist surgeons in planning cases with patient-specific 3D models. “This technology will not only help the surgeon prepare, predict and plan for any potential complication but will also improve patient
Devices
FDA has granted miR Scientific a Breakthrough Device Designation for its miR Sentinel PCC4 Assay, a prostate test that offers a new method to analyze small non-coding RNAs derived from a urine specimen from age-eligible men. The company says the test uses a “statistical classification algorithm” to score
Devices
FDA has granted CartiHeal a breakthrough device designation for the Agili-C implant and its use in treating cartilage lesions in arthritic and non-arthritic joints. CartiHeal is currently conducting a pivotal clinical study to evaluate the implant’s superiority over the current surgical standard of care – microfracture and debridement.
Devices
FDA has cleared a GE Healthcare 510(k) for the Ultra Edition package on its Vivid cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that helps clinicians acquire faster, more repeatable exams consistently. The device features AI Auto Measure Spectrum Recognition which can detect the appropriate