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LumiraDx and Chembio announce COVID-19 Strategic Partnership

LumiraDx UK Ltd., today announced plans it has entered a strategic partnership with Chembio Diagnostics (Nasdaq: CEMI) to develop point of care test solutions for the detection and monitoring of the COVID-19 virus, and IgG and IgM antibodies. The agreement builds on the strengths of both companies in delivering novel point of care test solutions.

“We are pleased to expand our relationship with Chembio as our partner given the company’s expertise and speed in developing high-quality point-of-care assays. By joining forces and bringing together the best of these two companies, we believe we will become the chosen approach for the detection and monitoring of the COVID-19 virus, which has become a worldwide pandemic,” stated Ron Zwanziger, LumiraDx’s Chairman and Chief Executive Officer.

Point of care test solutions will be developed on both the LumiraDx and Chembio DPP platforms.

The LumiraDx Platform is a simple, easy to use, portable point of care test system. Its microfluidic technology enables accurate test results in line with those from hospital laboratory analyzers, using small patient samples, including capillary fingerstick blood. Fast results are delivered in minutes at the patient side and can be connected directly into the patient’s health record. The LumiraDx technology is designed to be cost-effective and applicable to many diagnostic assays, with a number of tests already in development and near to launch. The Platform will develop into a unique connected multi-test solution with the potential to accelerate diagnostic testing to improve clinical decision-making and patient experience, leading to better outcomes.

ACR Recommendations for the use of Chest Radiography and Computed Tomography (CT) for Suspected COVID-19 Infection

 

To date, most of the radiologic data comes from China. Some studies suggest that chest CT in particular may be positive in the setting of a negative test. We want to emphasize that knowledge of this new condition is rapidly evolving, and not all of the published and publicly available information is complete or up-to-date.

Key goals for the U.S. health care system in response to the COVID-19 outbreak are to reduce morbidity and mortality, minimize disease transmission, protect health care personnel, and preserve health care system functioning.

The ACR believes that the following factors should be considered regarding the use of imaging for suspected or known COVID-19 infection:

  • The Centers for Disease Control (CDC) does not currently recommend CXR or CT to diagnose COVID-19. Viral testing remains the only specific method of diagnosis. Confirmation with the viral test is required, even if radiologic findings are suggestive of COVID-19 on CXR or CT.
  • For the initial diagnostic testing for suspected COVID-19 infection, the CDC recommends collecting and testing specimens from the upper respiratory tract (nasopharyngeal AND oropharyngeal swabs) or from the lower respiratory tract when available for viral testing.
  • Generally, the findings on chest imaging in COVID-19 are not specific, and overlap with other infections, including influenza, H1N1, SARS and MERS. Being in the midst of the current flu season with a much higher prevalence of influenza in the U.S. than COVID-19, further limits the specificity of CT.

Additionally, there are issues related to infection control in health care facilities, including the use of imaging equipment:

  • Primary care and other medical providers are attempting to limit visits of patients with suspected influenza or COVID-19 to health care facilities, to minimize the risk of spreading infection. The CDC has also asked that patients and visitors to health care facilities be screened for symptoms of acute respiratory illness, be asked to wear a surgical mask and be evaluated in a private room with the door closed.
  • In addition to environmental cleaning and decontamination of rooms occupied by a patient with suspected or known COVID-19 infection by thorough cleaning of surfaces by someone wearing proper protective equipment, air-flow within fixed radiography or CT scanner rooms should be considered before imaging the next patient. Ventilation is an important consideration for the control of airborne transmission in health care facilities . Depending on the air exchange rates, rooms may need to be unavailable for approximately 1 hour after imaging infected patients; air circulation rooms can be tested.
  • These measures to eliminate contamination for subsequent patients may reduce access to imaging suites, leading potentially to substantial problems for patient care.

Based on these concerns, the ACR recommends:

  • CT should not be used to screen for or as a first-line test to diagnose COVID-19
  • CT should be used sparingly and reserved for hospitalized, symptomatic patients with specific clinical indications for CT. Appropriate infection control procedures should be followed before scanning subsequent patients.
  • Facilities may consider deploying portable radiography units in ambulatory care facilities for use when CXRs are considered medically necessary. The surfaces of these machines can be easily cleaned, avoiding the need to bring patients into radiography rooms.
  • Radiologists should familiarize themselves with the CT appearance of COVID-19 infection in order to be able to identify findings consistent with infection in patients imaged for other reasons.

Recommended Resources:

Centers for Disease Control:

Radiologic articles and collections:

Simpleware AS Ortho Now Available as Machine Learning-Based Auto Segmenter Module for 3D Image Processing

Simpleware AS Ortho

Highlights:

  • Automated 3D image segmentation module powered by Artificial Intelligence (AI) technology using Machine Learning (ML) algorithms
  • Time and cost-saving, scalable solution for medical device R&D, pre-surgical planning, and in silico clinical trials
  • Based on hundreds of hours of algorithm training from medical datasets with outputs checked by clinical professionals, ensuring reliable and consistent results
  • Includes additional capabilities for automated landmarking of segmented image data

Industry Challenges

Segmentation of 3D image data from sources like MRI and CT is typically very time-consuming, with those working on the data having to take the time to extract regions of interest form data when working on models. In the case of medical device design and pre-surgical planning, segmentation of the human anatomy is one of the key bottlenecks to getting on to more meaningful analysis and product innovation.

Synopsys, Inc. are tackling this challenge with the launch of Simpleware AS Ortho (Auto Segmenter for Orthopedics), a new Simpleware ScanIP software module for automated segmentation of medical images. Simpleware AS Ortho is powered by Artificial Intelligence (AI) technology using Machine Learning (ML) algorithms.

Embedded in the Simpleware ScanIP software platform and building on its established segmentation capabilities, the new module significantly reduces traditional bottlenecks around manual segmentation of hips and knees. With Simpleware AS Ortho, users will see a 20 to 50 times faster rate of segmentation, meaning that previously tedious work is reduced or eliminated altogether to free up engineering time and resources for analysis and innovation.

Why It Matters

According to the journal Orthopedic Surgery, total knee arthroplasties (TKAs) in the USA will grow by 484%, from 719,000 in 2015 to 3.48 million by 2030, while total hip arthroplasties (THAs) will grow by 172%, from 332,000 to 572,000 in the same period. The Simpleware AS Ortho, together with Simpleware ScanIP, helps reduce the difficulty of meeting this demand, as described below by Johann Henckel MD, Orthopaedic Surgeon, Royal National Orthopaedic Hospital, UK.

“Image segmentation of MRI and CT scans presents a significant challenge for our surgical and engineering multidisciplinary teams. We have interacted with the Simpleware Product Group at Synopsys for solutions to this challenge and are excited with the development of their automated ML-powered tools for the rapid segmentation of clinical images which aligns closely with our own innovation needs. What is currently a laborious process that occupies significant engineering resources and time, can now be completed quickly, accurately and with less variability, promising a scalable solution for generating high-fidelity patient-specific models, surgical tools and bespoke implants.”

 

 

 

 

 

 

 

 

 

 

 

 

 

Florian Elsaesser Appointed Chief Commercial Officer of Biocare Medical

Prior to Siemens Audiology’s acquisition by Private Equity fund EQT, Florian Elaesser held senior financial roles managing global functions in finance and controlling.

After the acquisition, Florian went on to hold senior business development and marketing roles in the newly rebranded Sivantos. In these roles, he managed the acquisition and integration of companies and coordinated global sales and marketing functions. Florian holds a Master’s degree in Economics from Technische Universität Berlin and graduated in Management from the renowned Ecole Supérieure de Commerce de Paris (ESCP).

Mr. Elsaesser’s appointment follows the completion of two of the largest and longest followed up clinical trials ever conducted in tinnitus, including 517 participants. Mr. Elsaesser will be responsible for advancing the commercialization of the Neuromod’s breakthrough tinnitus treatment product – Lenire™.

The Company is working towards the European commercialization of Lenire®; scaling up manufacturing capacity to meet anticipated European demand, and progressing US regulatory strategy to secure market entry into the United States. Mr. Elsaesser will play a key role in these developments.

Welcoming the appointment, Dr. Ross O’Neill, CEO of Neuromod said: “I am delighted to announce that Florian Elsaesser will be joining the Neuromod team as Chief Commercial Officer. Attracting a leading hearing aid industry expert with extensive experience across the sector is an exciting development and recognition of the immense potential of our technology. It is a pivotal time for the Company as we progress with the European commercialization of Lenire™. Florian’s experience will be crucial as we work towards delivering our much-anticipated breakthrough treatment to people currently living with tinnitus.”

Mr. Elsaesser added: “With Lenire™ Neuromod has developed a fantastic treatment option for the millions of tinnitus sufferers globally whose clinical needs remain underserved. Lenire™ has achieved compelling results in multiple large-scale clinical trials. Personally, I am excited about the high overlap between tinnitus and hearing impairment. For a huge number of patients, tinnitus is often a leading indicator of hearing loss. These patients tend to seek treatment for tinnitus much earlier than for hearing loss. Therefore I see huge opportunities for Lenire™ to boost the hearing aid retail market.”

Herta Launches a New Technology That Allows Facial Identification Even With a Mask

Based on Deep Learning technology, Herta’s algorithms provide very high identification rates, especially in identity verification tasks and their reliability is very high, even when people hide a large part of their face. It is worth noting that the most differential part of the human face is in the eye region.

The launch of this software is key for automatic passenger identification systems, such as border control with the passport. This way it will not be necessary for the person to remove the mask, avoiding possible contagion or long waiting times. Its application, in general, extends to any type of access control or identity verification system.

Herta expects that the impact of this new technology in the market will be very important worldwide and that it will be massively used in environments such as transportation, health, government, events, sports stadiums or in the gaming sector.

PROCEPT BioRobotics Announces Multi-Center, Real World Clinical Study Outcome

PROCEPT BioRobotics Corporation, a surgical robotics company developing intelligent solutions to transform the field of urology, has announced that the safety and efficacy outcomes from a multi-center study of Aquablation therapy replicated those achieved in its pivotal clinical trials.

Aquablation therapy is a procedure for the treatment of benign prostatic hyperplasia (BPH), and is performed by the AquaBeam® Robotic System, the first FDA cleared, automated surgical robot for the treatment of this common condition.

“This study provided a very important validation of Aquablation therapy, as this is the first multi-center publication of outcomes in a commercial setting,” said Reza Zadno, president and CEO of PROCEPT BioRobotics. “These findings not only confirm the outcomes we saw in our landmark clinical trials but will also help encourage acceptance and adoption of Aquablation therapy as a new BPH treatment of choice for all prostates, in markets worldwide.”

OPEN WATER was a prospective, multicenter, single-arm, open-label clinical trial of the Aquablation procedure. One hundred and seventy-eight men with prostates sized between 20 and 150 cc were enrolled between September 2017 and December 2018 across five geographies, including Hamburg, Germany; Tauranga, New Zealand; Beirut, Lebanon; Melbourne, Australia; and Frimley, England. Open Water demonstrated large improvements at 12 months in symptom relief and peak urinary flow rates while preserving sexual function and urinary continence.

The study data, which were published in the Journal of Clinical Medicine, demonstrated large improvements at 12 months in symptom relief and peak urinary flow rates while preserving sexual function and urinary continence. Similar levels of symptom relief were seen independent of surgical experience. Moreover, the authors reported that no patient underwent a secondary procedure for recurrent BPH symptoms.

“As noted in our paper, the OPEN WATER study results indicate that the Aquablation procedure provides high levels of symptom relief, consistent with most resective techniques, but with an approximately eight times lower impact on sexual function,” said lead author Prof. Thorsten Bach, Asklepios Westklinikum Hamburg-Rissen. “The magnitude of symptom relief combined with such low rates of sexual dysfunction should give confidence to every urologist considering the adoption of Aquablation therapy in his or her practice.”

RubiconMD Secures $18M in Series C Financing Led by Deerfield Management Company

RubiconMD, the leading eConsult platform providing access to specialist expertise, today announced it raised $18 million in Series C funding led by Deerfield Management Company.

Also participating in this investment round are existing investors including Optum Ventures, HLM Venture Partners, Waterline Ventures and Heritage Provider Network. To date, the Company has raised more than $40 million.

As part of the financing round, RubiconMD is adding Julian Harris, M.D., Partner at Deerfield, to the Company’s Board of Directors. Trained as a primary care physician, Dr. Harris has played a key role in helping to accelerate the country’s shift towards value-based payment through senior roles in the public and private sector.

“We are at a crucial moment in the shift towards a value-based health care system, with private and public payers seeking to find innovative ways to improve quality and affordability,” Dr. Harris said. “By enabling primary care clinicians to practice at the top of their license, RubiconMD serves as a vital partner for the country’s most innovative primary care groups, helping them to improve outcomes for patients and to reduce costs for our system.”

Optum Ventures, who co-led the Company’s last round of funding, joined Deerfield in the current round. “By removing the barriers to receiving specialty insights in all settings of care, RubiconMD is driving healthcare towards a more accessible, value-based ecosystem,” said Laura Veroneau, Partner at Optum Ventures and Board member. “RubiconMD has seen remarkable growth and we are thrilled to continue partnering in their work to bring the healthcare industry into the future.”

Motivated by their own experiences within the healthcare system, CEO Gil Addo and President Carlos Reines founded RubiconMD in 2013 to bridge the gap between primary and specialty care. Today, the platform offers quick access to specialist insights across more than 120 specialties. The company has partnered with the top payors in the country to scale its offering.

“We are delighted to bring on Deerfield as an investor,” said Addo. “Deerfield’s experience, reach and commitment to realizing the future of healthcare will be pivotal as we continue to break down barriers to access and ensure all patient populations receive the care they need.”

The Company expects to use the new capital to fuel its ongoing growth. RubiconMD also plans to leverage its data to deliver new product offerings to better serve primary care clinicians. “Our goal has always been to empower primary care.” said Reines. “We remain focused on ensuring that the right information is delivered into the hands of the primary care clinician at the right time, so they are able to drive towards better, more efficient care delivery.”

 

TruMed Systems, Inc. and MEDENT Announce AccuVax® MEDENT Integration

“We are thrilled to collaborate with TruMed and provide the AccuVax MEDENT integration for our customers,” said MEDENT’s VP of Sales and Marketing Barbara Cuthbert. “AccuVax offers the emerging standard in vaccine storage and management for any immunization provider.”

Cuthbert added, “No other vaccine system can provide an all-in-one solution that guarantees vaccine integrity, frees staff time, eliminates vaccine waste and maximizes patient safety. Combining AccuVax with MEDENT is the best solution that provides robust functionality and seamless interoperability that enhances our full offering to our customers.”

“The goals of both MEDENT and AccuVax are to help our customers create value and allow more time for patient care,” said Jesper Jensen, CEO of TruMed Systems. “We are proud to integrate with such a customer-centered organization to expand on our workflow efficiencies and reduce charting requirements and greatly enhance patient safety by eliminating errors for all MEDENT customers around the country.”

COVID-19 FDA Update: Foreign Inspections

The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees, Centers for Disease Control and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of our employees.

Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

We are aware of how this action may impact other FDA responsibilities, including product application reviews.  We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.

When we are temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure we employ additional tools to ensure the safety of products imported to the U.S., which have proved effective in the past. These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections. For example, we began exercising this authority when we postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak. This is all part of the FDA’s multi-pronged and risk-based approach to ensuring quality, as well as compliance, with applicable federal laws and regulations.

The FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law.

The FDA has the ability through our risk-based import screening tool (PREDICT) to focus our examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.  We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.

Americans can rest assured the FDA is diligently monitoring this outbreak and the impact to our operations. Our leadership team meets daily to talk about the myriad of urgent issues facing us as we actively facilitate efforts to diagnose, treat and prevent the disease; survey the medical product supply chain for potential shortages or disruptions and help to mitigate such impacts, as necessary; and leverage the full breadth of our public health tools, including enforcement tools to stop fraudulent COVID-19 activity.

As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed to help advance federal response efforts in the fight against this outbreak.

Other FDA news items can be found here.

Exero Medical Appoints Prominent Gastrointestinal Expert Professor Charles Knowles to its Scientific Advisory Board

Exero Medical, developer of a biodegradable wireless sensor for early detection of anastomotic leaks (AL) following GI surgery, today announced the appointment of Charles Knowles, Professor of Surgery at Queen Mary University of London and Consultant Colorectal Surgeon at Barts Health NHS Trust, to its scientific advisory board.

“We are excited to welcome Professor Charles Knowles, whose clinical expertise and deep knowledge of the gastrointestinal field brings immediate value to Exero Medical, and will be instrumental in navigating both clinical trials and clinical implementation of our AL detection technology,” said Erez Shor, PhD, CEO of Exero Medical. “Professor Knowles provides us with an axis between the operation and functionality of our leak detection system and its clinical application. His expert input will be vital in the development of our technology, which will result in better, safer care of GI surgery patients.”

Professor Knowles has been a major contributor to the field of gastrointestinal research for over 25 years. Professor Knowles is Deputy Director of the Blizard Institute and Honorary Professor of Experimental Therapeutics at UCL. He is Chair of several research committees including the European Society of Coloproctology. Professor Knowles has authored over 190 peer reviewed publications as well as contributed several book chapters to major international colorectal and general surgical texts.

“AL has a 6-10% occurrence rate post-operation in lower GI procedures and can lead to life threatening complications, with substantial risk of mortality,” said Professor Knowles. “I look forward to working closely with the Exero Medical team, whose technology is novel to this field, to address this widespread issue and help alert physicians to post-operative AL early on, allowing for timely medical intervention and improved patient outcomes.”

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