Devices
FDA has cleared a NinePoint Medical 510(k) for the Real-time Targeting feature for its NvisionVLE Imaging System. The company says the device uses its Optical Coherence Tomography technology to allow physicians to perform Volumetric Laser Endomicroscopy (VLE) procedures, producing real-time, high-resolution cross-sectional images to help
Devices
FDA has granted a waiver for Circulatory System Devices Panel chairman Richard L. Page despite a conflict of interest when the panel reviews and votes 5/24 on a St. Jude Medical PMA for its Amplatzer PFO Occluder. The device is intended to be permanently implanted to close patent foramen
Devices
FDA has cleared a CareTaker Medical 510(k) for its Beat-by-Beat Blood Pressure and Heart Rate Monitor. The wearable device uses the company’s Finger Cuff technology to allow uninterrupted wire- and electrode-free vital signs monitoring “throughout the full mobile continuum of care; within the clinic and
Devices
Softpedia reports online that the crash of a physician’s computer used to display data from a Merge Hemo medical device during a cardiac catheterization procedure was determined to be caused by the computer’s antivirus software initiating a scan during the procedure. The report says that the adverse event
Devices
CDRH says its “de novo” medical device clearance program will need more resources under the next user fee reauthorization period in order to operate efficiently. According to meeting minutes from an FDA/industry user fee reauthorization negotiation meeting last month, CDRH officials said the program has been increasing and performance
Devices
FDA has cleared an Irvine Scientific 510(k) for expanded use of its Vit Kit vitrification media to include human oocytes. The company says it is the first to obtain such a clearance. Its Vit Kit-Freeze and Vit Kit-Thaw are now intended for use with oocytes, pronuclear zygotes
Devices
FDA has released a draft guidance on “Technical Considerations for Additive Manufactured Devices” that provides regulatory recommendations for device makers using 3-D printing in their manufacturing. The document outlines technical considerations associated with additive manufacturing (AM) processes, and includes recommendations for testing and characterization for devices that include at
Drugs
Researchers from many countries say that responding to President Barack Obama’s call to modernize the current regulatory landscape for precision medicine will be no easy task. The worldwide regulatory challenges that arise in response to calls for precision medicine were explored in a 2014 workshop in Hobart, Australia. Information
Devices
Medical device companies should move quickly to implement the ISO 13485:2016 quality management standard update, according to consulting firm Emergo. Although the standard has a three-year transition period for compliance with the update, the firm’s online post says that companies would be smart to begin advance planning
Devices
FDA has inexplicably reversed position on its recall of some 2,800 Custom Ultrasonics scope-cleaning machines, according to a Kaiser Health News report. The agency had ordered the equipment off the market 11/2014, saying that Custom repeatedly violated safety laws, increasing the risk of patient infection. The recall
Devices
FDA has cleared a Signostics 510(k) for Uscan, which the company describes as the first smart mobile-connected ultrasound visualization device targeted at urologic care. “Using algorithms from the science of computer vision, Uscan actively recognizes the 3D contours of the bladder, for far more accurate volume measurements than
Devices
Cambridge Cognition has filed a 510(k) for its CANTAB Mobile, a device developed to detect episodic memory impairments in early stage Alzheimer's disease patients aged over 50. The CANTAB technology contains a suite of the “world's most validated and sensitive touchscreen neuropsychological tests of cognition,
Devices
FDA says B. Braun is recalling 1,033 units of its Dialog+ Hemodialysis Systems manufactured between 4/1/13 and 7/3/13, and distributed between 6/25/13 and 10/7/15. The company says the recall is due to cracks in conductivity sensors that may allow air to
Devices
FDA has approved a Boston Scientific PMA for two catheters that can be used with its Rhythmia Mapping System — the IntellaNav XP and the IntellaNav MiFi XP navigation-enabled ablation catheters — which are intended to treat Type I atrial flutter. “These are the first magnetically-tracked catheters that Boston Scientific
Drugs
The HHS Office of Inspector General (OIG) finalized 4/18 a guidance explaining how it will base its decision to exclude drug or medical device companies or their personnel from federal healthcare programs due to False Claims Act suits or investigations. The guidance says a decision to exclude is based
Devices
FDA has approved a Biotronik PMA for its Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging scans. The device also has a remote monitoring feature with daily automatic transmission, and a closed-loop stimulation feature that adapts the
Devices
A 9/14-25/15 FDA inspection at Grams Medical Products, Costa Mesa, CA, found Quality System Regulation violations in the firm’s manufacturing of the Grams Aspirator S-300. A just-released 3/17 Warning Letter from the agency’s Los Angeles District Office says that violations listed on
Devices
FDA has cleared a First Ray 510(k) for its Stealth Staple System, an intraosseous small bone fixation device for treating arthrodesis, osteotomies and bone fractures. Current standard-of-care devices are primarily bone plates and bone screws, or bone staples, according to the company. “Due to the prominence above
Devices
AdvaMed says there are several items in an FDA draft guidance on homologous use of human cells, tissue, and cellular and tissue-based products (HCT/Ps) that industry views positively, and several areas where industry disagrees or believes that improvements are needed. In a 4/20 comment letter, it says
Devices
Attorney Michelle Yorty (Dechert) is praising a Texas federal court decision that threw out with prejudice all claims against Covidien from a patient who claimed that the company’s embolization device that was implanted in her brain caused her to suffer a blocked blood vessel that led to mini strokes
Devices
Despite reported issuance of a Justice Department subpoena against the company, FDA 5/2 ducked when asked if it is investigating allegedly defective Halyard Health surgical gowns reported 5/1 by CBS 60 Minutes. Agency spokesperson Angela Stark trotted out FDA’s routine evasion in an email to FDA Webview:
Devices
FDA has cleared a Medtronic 510(k) for its StrataMR valves and shunts, which are used in treating patients with hydrocephalus and cerebrospinal fluid disorders. The clearance covers the device’s acceptable performance during magnetic resonance imaging (MRI) examinations, according to the company. The device contains a magnet inside the