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Biotechnology News Magazine

BD Introduces Smart Connected Robotics to Automate Microbial Identification (BD Kiestra™)

BD Kiestra™ IdentifA Receives 510(K) Clearance for Automated Sample Processing and MALDI Target Preparation

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BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD Kiestra™ IdentifA system, which is designed to automate the preparation of microbiology bacterial identification testing.

Identifying the microorganism that is causing an infection is a labor-intensive process. With the BD Kiestra™ IdentifA, the lab technician uses BD Synapsys™ informatics to select discrete bacterial colonies from a digital plate image. Sophisticated robotics then physically pick those selected organisms and prepare the sample for specific identification testing. By automating what are typically cumbersome manual steps, the BD Kiestra™ IdentifA may reduce the potential for human error when preparing samples for bacterial identification and produce more accurate diagnoses for patients. Streamlining processes also enables lab technicians to focus their time and expertise on higher-value tasks.

“BD continues to invest in automation and innovation for the microbiology laboratory to enable smart, connected, end-to-end workflows designed to accelerate insights and efficiency,” said Brooke Story, president of Integrated Diagnostic Solutions for BD. “Our ‘discovery to diagnostics’ strategy positions us to provide best-in-class solutions at every point along this continuum.”

BD Kiestra™ IdentifA is the only FDA-cleared solution that is available as part of a track-connected system for lab automation to support specimen preparation workflows for routine and challenging isolate types. The integration of the BD Synapsys™ Informatics solution with the BD Kiestra™ IdentifA, in combination with matrix-assisted laser desorption/ionization-time of flight (MALDI-ToF) mass spectrometry, can yield more rapid and accurate identification of bacteria and yeasts to aid clinician treatment decisions.

“The BD Kiestra™ IdentifA system transforms the manual workflow into one that is standardized, automated and digitized,” said Greg Miziolek, vice president and general manager of the U.S. region for BD Integrated Diagnostic Solutions. “Mass spectrometry methods, including MALDI-ToF technology, have innovated and advanced microbial identification in clinical microbiology but often require a significant number of process steps and hands-on-time. The BD Kiestra™ IdentifA system uses automated colony picking and MALDI-ToF spotting to reduce time to pathogen identification, which in turn can help improve patient management.”

Executives

Intelligent Implants Taps Leading Medical Device Entrepreneur, Benjamin A. Hertzog, PhD, as CEO

Dr. Hertzog will lead the progression of product development, clinical, and commercial activities for the company’s novel and proprietary smart orthopedic implant platform.

US Med-Equip Appoints 4 New Chief Executives

"We sought out superstars and brought in the best executives in their fields to join our burgeoning team. They will be instrumental in building on the growth of our company and our community of employees and healthcare partners we support," Salario said. Read who they are.

Perineologic Appoints Jim Fortune as President and Promotes Matthew Allaway, DO, to Chief Executive Officer

Mr. Fortune served as chief operating officer at Ocular Therapeutix, Inc. Dr. Allaway is the founder of Perineologic and has been a practicing urologist and managing partner at Urology Associates in Cumberland, Maryland.

FDA Updates

Medtronic Reports FDA Approval of Spinal Cord Stimulation Therapy for Treating Chronic Pain Resulting from Diabetic Peripheral Neuropathy

This new indication enables us to apply Medtronic's more than 40 years of proven SCS experience, as well as the company's deep diabetes expertise, to deliver better care to even greater numbers of diabetes patients.

Cardiovascular Systems, Inc. and OrbusNeich Announce FDA PMA Approval of Scoreflex® Scoring Balloon

Scott Ward, CSI’s Chairman, President and Chief Executive Officer, said, “We remain committed to expanding our portfolio of differentiated products that help physicians deliver improved outcomes for patients with complex coronary artery disease.

Nevro Reports FDA Approval for Expanded Labeling for Senza® Spinal Cord Stimulation System

This approval is specific to Nevro's proprietary 10 kHz Therapy and differentiates Nevro's Senza System as the only SCS system with specific labeling to treat NSRBP patients.
Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.
Tags

Diagnostic Imaging

Carestream Continues Drive to Improve Image Quality and Workflow With 45 Patents in 2021

“Carestream continuously strives to deliver cutting-edge technologies worldwide, and these patents demonstrate our commitment to meet the evolving needs of providers and patients alike,” said Eugene Shkurko, Intellectual Property Counsel at Carestream.

Aidoc Partners with Novant Health

By incorporating Aidoc's AI platform, which includes seven FDA-cleared solutions for triage and notification of patients with acute medical conditions, Novant Health is taking proactive steps to improve patient outcomes and reduce emergency department (ED) length of stay amid resource constraints inflicted by the Omicron variant.

Trials

NEJM: New Data on COVID-19 Lung Transplants

The analysis of more than 3,000 lung transplants in the U.S. between Aug. 1, 2020, and Sept. 30, 2021, showed that during the pandemic, 7% of the nation’s lung transplants were performed to treat severe, irreversible lung damage caused by COVID-19. More than half of these patients needed ventilators or extracorporeal membrane oxygenation, or ECMO, before their transplant.

Preclinical Study Provides Guidance for Optimizing Safety and Efficacy of Endovascular Hepatic Denervation Devices to Treat Diabetes

“This study leveraged our deep experience in preclinical evaluation of denervation therapies and could not have been performed in a timely manner without the digital morphometry techniques we developed in-house. We remain excited about the potential of neuromodulation technologies and are committed to supporting further innovation in this space,” explained Rami Tzafriri, PhD, lead author and Director of Research and Innovation at CBSET.

Other News

NEJM: New Data on COVID-19 Lung Transplants

The analysis of more than 3,000 lung transplants in the U.S. between Aug. 1, 2020, and Sept. 30, 2021, showed that during the pandemic, 7% of the nation’s lung transplants were performed to treat severe, irreversible lung damage caused by COVID-19. More than half of these patients needed ventilators or extracorporeal membrane oxygenation, or ECMO, before their transplant.

University of Colorado School of Medicine Will Work with DreaMed Diabetes to Deploy Its Advisor System as a New Resource for Diabetes Device Initiation

“We are truly honored to be part of this project,” said Ryan Hovey, general manager for North America at DreaMed. “We have been able to demonstrate the ability to support endocrinology practices by centralizing patient device data as well as providing evaluation reports and FDA cleared treatment recommendations.

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