Κυριακή 3 Απριλίου 2022

Envista Obtains FDA Clearance for Assisted Intelligence Mandibular Nerve Tracing

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 We are seeing more and more artificial intelligence systems enter into the healthcare space and dentistry in general.  Envista is a large player in the dental space, owning several companies under t he "umbrella" of Envista.

Many of the companies that are owned by Envista have products in the tech sphere and the company works hard with research & development to expand the use of its technologies across its portfolio.

Now comes word that the company has received FDA clearance for mapping of the inferior alveolar nerve.  The process, which has been referred to as "nerve tracing" for years has, until now, required manual input from the doctor. 

Before this discovery, it was necessary for the office to take a CBCT scan and then manually trace points along the mandibular canal.  When completed, the software would plot a line through all of the points to indicate the location of the canal throughout the mandible.

Now... that process has been automated.  I recently made a post about the dental A.I. company Pearl and how that company's FDA clearance was a watershed moment in dentistry.  Now we've reached another A.I. milestone in the profession.  This announcement is groundbreaking and these types of A.I. assisted procedures are only going to become more commonplace.

The profession has shown the FDA that these types of systems work reliably and this is only the beginning.  Here is full announcement from Envista:

Envista announced today the 510(k) Food and Drug Administration (FDA) clearance of its Assisted Intelligence (AI) mandibular nerve tracing feature in its image acquisition and diagnostic software platform DTX Studio Clinic.

The tracing of the mandibular nerve in modern dentistry is of high significance as it influences the available therapeutic options for the patient. The proper visualization of the nerve can prevent complications. When done manually, it is a task that can be both time-consuming and error prone. DTX's AI capabilities supports clinicians as they perform this important task.

This clearance complements a series of AI-powered functionality in DTX Studio Clinic. In 2017, Envista obtained FDA clearance for its AI-driven 3D virtual tooth setup algorithm. In 2020, a further clearance was received for automatic tooth position identification and automated sorting of full-mouth x-ray series. On March 25, the FDA cleared the third AI-focused 510(k) for the fully automated mandibular nerve tracing on CBCT scans.

Amir Aghdaei, Envista CEO, said, "This cle arance is another important step towards our digital strategy of expanding the capabilities of our powerful, unified, and open dental diagnostic software platform DTX Studio Clinic. With its combination of a user-friendly interface and AI-driven functionality, DTX Studio Clinic reduces the time clinicians spend on time-consuming tasks, while simultaneously helping prevent complications and enabling increased focus on the patient. We are particularly proud of our fully automated mandibular nerve tracing functionality with its high clinical relevance for dental implant-based patient rehabilitations."

About Envista Holdings Corporation

Envista is a global family of more than 30 trusted dental brands, including Nobel Biocare, Ormco, DEXIS, and Kerr united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers a broad range of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. With a foundation comprised of the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus, Envista is well equipped to meet the end-to-end needs of dental professionals worldwide. Envista is one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, pl ease visit www.envistaco.com.

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Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts

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Abstract

Successful translation of new and innovative medical products from concept to clinical use is a complex endeavor that requires understanding and overcoming a variety of challenges. In particular, regulatory pathways and processes are often unfamiliar to academic researchers and start-ups, and even larger companies. Growing evidence suggests that the successful translation of ideas to products requires collaboration and cooperation between clinicians, researchers, industry, and regulators. A multi-stakeholder group developed this review to enhance regulatory knowledge and thereby improve translational success for medical devices. Communication between and among stakeholders is identified as a critical factor. Current regulatory programs and processes to facilitate communication and translation of innovative devices are described and discussed. Case studies are used to highlight the importance of flexibility when considering evidence requirements. We provide a revi ew of emerging strategies, opportunities, and best practices to increase the regulatory knowledge base and facilitate medical device translation by all stakeholders.

Graphical abstract

Clinicians, regulators, industry, and researchers require regulatory knowledge and collaboration for successful translation of innovative medical devices

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18F-FDG-PET/CT can be used to predict distant metastasis in hypopharyngeal squamous cell carcinoma

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Hypopharyngeal squamous cell carcinoma (HPSCC) has a high rate of distant metastasis, resulting in poor prognosis. The role of the maximum standardized uptake value (SUVmax), which was assessed via pretreatmen...
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In Vivo Murine Models of Cardiotoxicity Due to Anticancer Drugs: Challenges and Opportunities for Clinical Translation

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Abstract

Modern therapeutic approaches have led to an improvement in the chances of surviving a diagnosis of cancer. However, this may come with side effects, with patients experiencing adverse cardiovascular events or exacerbation of underlying cardiovascular disease related to their cancer treatment. Rodent models of chemotherapy-induced cardiotoxicity are useful to define pathophysiological mechanisms of cardiac damage and to identify potential therapeutic targets. The key mechanisms involved in cardiotoxicity induced by specific different antineoplastic agents are summarized in this state-of-the-art review, as well as the rodent models of cardiotoxicity by different classes of anticancer drugs, along with the strategies tested for primary and secondary cardioprotection. Current approaches for early detection of cardiotoxicity in preclinical studies with a focus on the application of advanced imaging modalities and biomarker strategies are also discussed.

Graphical abstract

Potential applications of cardiotoxicity modelling in rodents are illustrated in relation to the advancements of promising research topics of cardiotoxicity. Created with BioRender.com.

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Endoscopic Adenoidectomy Replacing the Outdated Curette Adenoidectomy: Comparison of the Two Methods at a Tertiary Care Centre

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Abstract

To compare intraoperative and postoperative parameters of the two techniques of adenoidectomy, endoscope and microdebrider powered adenoidectomy and conventional adenoidectomy. Study Design Prospective study. Setting: Academic tertiary referral centre. In our study, cases of adenoid hypertrophy were randomly selected from the outpatient department of department of ORL & HNS. Out of these patients, 30 underwent Endoscopic adenoidectomy (EA) (Group A) and 30 underwent Conventional adenoidectomy (CA) (Group B). All of the patients were assessed pre-operatively, intra-operatively and post-operatively to compare the various parameters. The most common complaint in both the groups was mouth breathing with snoring. Intra-operative bleeding was 29.15 ml in group EA and 15.2 ml in group CA. Operative time for CA was shorter at 21.8 min as compared to 32.1 min for group EA. Residual adenoids and injury to adjacent structures were more common in group CA. Hospital stay was 3.2 days for EA patients and 3.43 days for CA patients. Resolution of symptoms was near comparable in both groups. Operative time and intra-operative bleeding are both significantly reduced with the CA as opposed to EA. However, injury to adjacent structures and residual adenoids occur significantly less in group EA. After weighing the risks and benefits, we can conclude that EA is comparatively better than CA.

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Readmission Rates Following Major Head and Neck Surgery With Concurrent Tracheostomy

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Annals of Otology, Rhinology &Laryngology, Ahead of Print.
Objectives:To determine the influence of major head and neck procedures on readmission and complication rates following tracheostomy.Methods:A retrospective cohort study using the 2005 to 2017 National Surgical Quality Improvement Program (NSQIP) database. Current Procedural Terminology codes were used to identify tracheostomy patients and to define the underlying head and neck procedure. Patients under the age of 18 and with unknown pre-operative variables were excluded. Univariate and multivariable analyses were performed.Results:A total of 3240 tracheostomy patients undergoing major head and neck surgery were identified in NSQIP. The 30-day mortality rate was 104 (3.2%) and 258 (9.0%) patients were readmitted. 637 (19.7%) patients had an unplanned return to the operating room. There were 1606 (49.6%) non-tracheostomy specific complications, which included 850 (26.2%) medical and 1142 (35.2%) surgical complica tions. On multivariable analysis, we found that the underlying procedures did not impact the risk of readmission (P > .05 for all). The underlying procedure was also not associated with unplanned return to the operating room except for thyroidectomies, which had a lower risk than free tissue graft reconstruction (OR = 0.53 (95%CI 0.31, 0.88), P = .018).Conclusion:While almost 1 in every 2 patients had a complication following major head and neck surgery that included creation of a tracheostomy, the rate of readmission is comparatively low and is not associated with the underlying procedure. These findings should reassure head and neck surgeons that properly managed tracheostomies do not constitute a disproportionate risk of readmission.
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The Effect of Topical Tranexamic Acid in Endoscopic Sinus Surgery: A Triple Blind Randomized Clinical Trial

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Annals of Otology, Rhinology &Laryngology, Ahead of Print.
Objective:Our aim is to evaluate the effect of topical tranexamic acid (TA) on bleeding and surgical quality field in the functional endoscopic sinus surgery (FESS).Methods:A total of 74 patients who underwent FESS due to chronic rhinosinusitis were included. The patients were randomized into 2 groups. TA group (n = 37) received a topical cotton pledget soaked with TA and placebo (PL) group (n = 37) received a pledget soaked with saline solution.Results:A significant effect was noted for the TA group versus the PL group in the grade 1 of the Boezaart scale at 35 minutes (4 for TA group and no case for PL group). This effect was absent for higher grades. We did not notice a significant effect between the 2 groups at 5 minutes. Blood loss was 359 ml in the TA group versus 441 ml in the PL group. No significant change was observed between the 2 groups concerning the blood parameters. No side effects were reported.Conclusion:Despite its safety when administrated locally and its low cost, TA provides limited effect on quality of surgical field after 35 minutes of the start of FESS in the patients with chronic rhinosinusitis. This effect was absent at the start of the intervention and when analyzing the blood loss and hematologic parameters.
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