Devices
Vision Advocacy president Paula Cofer, who also moderates a Facebook support group of over 7,000 people who suffer from complications associated with refractive eye surgery, such as LASIK, PRK, SMILE, and phakic intraocular lenses, has asked FDA commissioner Robert Califf to take regulatory action against refractive eye surgery providers
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FDA has cleared an Auris Health (Ethicon subsidiary) 510(k) for its Monarch surgery platform’s expanded use for endourological procedures. The clearance makes Monarch the first multispecialty, flexible robotic device for use in both bronchoscopy and urology, Auris says, adding that it is designed to enable urologists to reach
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CDRH is rolling out organizational changes that include new offices established within the Office of Product Evaluation and Quality. For example, the Office of In Vitro Diagnostics and Radiological Health is being split into two new offices — the Office of Health Technology 7 within the Office of In Vitro Diagnostics,
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After 13 years at the agency, CDRH Digital Health Center of Excellence director Bakul Patel has announced he will be leaving the agency early this month to explore an undisclosed new chapter in his professional life. In an announcement on his Linkedin page, Patel said: “It truly has been an
Devices
FDA is warning healthcare providers about the possibility that patients who have Medtronic’s Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may instead have a welding defect in the internal pump causing the pump to malfunction. According to a just-released Medtronic Urgent Medical
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FDA has updated its “Digital Health Policies and Public Health Solutions for Covid-19” Web page. An agency statement says the update: * provides examples of software functions identified in guidances issued during the Covid-19 public health emergency; * reflects policies and legislation currently in effect, including the software provisions of
Devices
The Medical Device Innovation Consortium (MDIC) has published its MDIC External Evidence Methods Framework, which was developed by experts from FDA, industry, and academia. MDIC says the framework is intended to help stakeholders navigate their way through the process of leveraging external data by harnessing the power of statistics. “The
Devices
Retired Ethicon senior principal quality engineer Eric Hinrichs says weighing risk versus reward is the key to successful medical device product development. And the way to make such an assessment, he writes in a Med Device Online guest column, is through using risk documents. “Failure mode and effect analysis documents
Devices
FDA says it is evaluating the potential risk of airway obstruction when using two Medtronic silicone-based electromyogram (EMG) endotracheal tubes. An agency letter to healthcare providers identifies the affected devices as the Medtronic NIM Standard Reinforced EMG Endotracheal Tube and the Medtronic NIM Contact Reinforced EMG Endotracheal Tube. The
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CDRH Digital Health Center of Excellence director Bakul Patel tells the Association for the Advancement of Medical Instrumentation that in his new position as chief digital health officer of global strategy and innovation, he will focus on two key areas: developing a strategy for advancing digital health technology and addressing
Drugs
Attorney Bryan Feldhaus (DuVal & Associates) says his firm does not think the new FDA “intended use” rule published on 9/1/21 represents a material change for drug and device manufacturers in 2022. In this way, his analysis differs from some observers who have projected an increased exposure for
Drugs
Six Wilson Sonsini attorneys say FDA enforcement actions were featured in the Justice Department Civil Division’s Consumer Protection Branch’s (CPB) first-ever “recent highlights” report. In an online post, the attorneys say (includes link to report) the report “gives some insight into the enforcement trends companies can expect
Devices
Medtronic has recalled (Class 1) its Harmony Delivery Catheter due to the potential for a break to occur in the bond holding the capsule at the end of the delivery catheter. The recalled device is part of the company’s Harmony Transcatheter Pulmonary Valve (TPV) System, which is used to
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The Justice Department says 11 defendants, including the founders of several lab companies — Unified Laboratory Services, Spectrum Diagnostic Laboratory, and Reliable Labs — have pleaded guilty in a $300 million scheme to pay kickbacks to induce medical professionals to order medically unnecessary lab tests, which they then billed to Medicare and
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FDA has released a final guidance entitled Refuse to Accept Policy for 510(k)s that outlines the procedures and criteria the agency intends to use in assessing whether a medical device premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review.
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FDA says recalls of the Philips Respironics V60 ventilator, V60 Plus ventilator, and V680 Plus ventilator were all Class 1. In each instance, Philips says ventilator units have been identified to have an issue affecting an internal electrical circuit that in some cases could potentially result in the ventilator failing
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FDA has granted Bridge to Life a breakthrough device designation for its LifeCradle Heart Preservation Transport System, intended to provide preservation, storage, monitoring, and transportation of donor hearts using hypothermic, oxygenated, nutrient perfusion from the time of organ procurement until transplantation into a recipient. “The inherently intuitive system utilizes a
Devices
The National Evaluation System for Health Technology Coordinating Center (NESTcc), created by the Medical Device Innovation Consortium, is partnering with Aetion, a real-world evidence (RWE) analytics provider, in a five-year effort to advance the use of RWE in medical devices and diagnostics. An announcement says that as part
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FDA will hold a three-day virtual public workshop on “Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration” on 6/7-9. A meeting announcement says the workshop is to discuss ways to foster resiliency in the medical device supply chain and to seek
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FDA says patients and healthcare providers should be aware of the risk of false results with genetic non-invasive prenatal screening (NIPS) tests, sometimes called noninvasive prenatal testing or tests. An agency safety communication says results from such tests can provide information about the possibility of a fetus having certain
Drugs
Drug sponsors should consider making race and ethnicity diversity plans an important part of their drug development plans, according to a law firm’s analysis of the agency’s recently published draft guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.
Devices
FDA has cleared a SonoScape 510(k) for its flagship video endoscopy system HD-550 for gastrointestinal diagnosis. The device uses a 4-LED light source for 1080P high definition in multi-spectrum and multi-mode applications. It also features chromoendoscopy Spectral Focused Imaging and versatile Intelligent Staining Technology light