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Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Modulim Announces CE Mark of Clarifi Imaging System for Microvascular Assessment

Modulim can now expand its marketing and distribution throughout Europe and apply for registration in other international markets that recognize the CE Mark.

Genius AI Detection Receives FDA Clearance

Hologic notes the new technology which the company has now made commercially available represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius 3D Mammography exam.

Linde Partners with 3D Medlab in Pioneering Research to Optimize 3D Printing of Complex Structures for Medical Devices

Today Linde announced it has started pioneering research into how atmospheric conditions in the additive manufacturing process can be optimized to produce complex latticed structures for medical devices. In collaboration with 3D Medlab, a leader in additive manufacturing for the medical sector, the joint project is the first of its kind and represents a milestone in the field of orthopedic device development.

Multifaceted, latticed components aim to mimic human body parts and can better assimilate into the patient’s own bone and tissue structure, leading to fewer rejections and quicker healing times. Additive manufacturing can optimize the production of such components ensuring high-quality repeatability of the process and requiring less post-print finishing. However, the atmosphere in the printing chamber needs to be optimal and reproducible.

Atmospheric gases play a fundamental role in the printing process and any impurities that remain in the chamber, even once purged, can have a detrimental effect on the part being manufactured. Additionally, fumes created during the production process can remain on the part, requiring post-production cleaning.

Even extremely small variations in oxygen content can impair the mechanical or chemical properties of metals sensitive to oxygen – such as titanium and aluminum alloys – and can affect the composition of the end product. For the Linde/3D Medlab research trials, the titanium alloy in question is Ti-6AI-4V.

“We are proud to be collaborating with 3D Medlab on this important and forward-looking project,” said Pierre Forêt, Senior Expert Manufacturing, Linde. “As a customer at the forefront of medical device manufacturing, anything less than optimal product outcomes is critically important to avoid, so it is testament to our gases expertise and know-how that we have been selected to partner in this endeavor.”

The atmospheric trials involve a new helium/argon gas mixture created especially by Linde for the project to make the process smoother and cleaner, along with use of Linde’s ADDvance O2 precision, a first-of-a-kind oxygen measuring and analysis technology to ensure the optimal mix of gases within the print chamber. Along with the new gas mixture, ADDvance O2 precision will give 3D Medlab precise, granular control over the oxygen concentration and humidity levels in the print chamber.

“Our experience with Linde shows that they are as committed to the same high standards of precision and excellence in additive manufacturing that we are,” said Gaël Volpi, CEO, 3D Medlab. “Full regulatory compliance is a fundamental cornerstone in our engineering and design process and our customers trust us to ensure all proper measures and controls are in place.”

Linde began its association with 3D Medlab originally through the supply of its ADDvance powder cabinet, designed to retain the quality of valuable, sensitive metal powders used in the additive manufacturing process by protecting them from exposure to ambient air and humidity. While the current collaboration between Linde and 3D Medlab is focused on Ti-6AI-4V lattice structures, future efforts will include the potential of nickel titanium (also known as nitinol) in view of its excellent shape memory and super elasticity, making it an ideal candidate for next generation stents.

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Fusion Antibodies and Queen’s University Belfast Awarded a £453,000 Grant from Invest Northern Ireland

The two organisations will use the funds to accelerate the discovery of novel therapeutic and diagnostic antibodies with validated anti-infective properties against COVID-19. Building on strong scientific knowhow, a new antibody development platform will be created that will help realise the vision of producing a breakthrough therapeutic that directly targets SARS-CoV-2.

Attune Medical Major Milestones: Including ensoETM in Cardiac Ablation Procedures Published Study and $4 Mil Convertible Note Closing

Dr. Mark Gallagher (St. George’s University Hospital, London UK) evaluated the use of the ensoETM in cardiac ablation procedures to ascertain whether using the esophageal space for temperature management could have the potential to decrease collateral thermal injury related to radio-frequency (RF) ablation for the treatment of atrial fibrillation.

Signia Introduces World’s First ‘Face Mask Mode’ for Hearing Devices: Improves Audibility for Those Communicating with Someone Wearing a Face Covering & No More Lip Reading

“The hearing challenges presented by face masks became obvious pretty quickly into the pandemic, so Signia developed the first-of-its-kind Face Mask Mode to help those with hearing loss better communicate in this new reality,” said Tish Ramirez, Au.D. of Signia. “When this setting is activated, the hearing aids optimally capture the sound of the speech signals, enabling the words to sound clearer and reducing any background noise to help the wearer understand what is being said.” 

Kayentis, a global provider of digital data capture systems for clinical trials, today announces it has raised €7M (approx. $8.3M) in growth capital.

Kayentis is active in the global electronic Clinical Outcome Assessment (eCOA) market, which is expected to reach $2.6 billion by 2027. Market growth in eCOA – a method of capturing outcomes data electronically in clinical trials – is driven by the clinical trials industry.

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New England Biolabs® Introduces NEBNext® Custom RNA Depletion Design Tool and RNA Depletion Core Reagent Set for Customizable RNA Depletion

This technology has been superb for eliminating the ribosomal RNA for a range of custom projects, including tracking novel viruses in mosquitoes, longitudinal profiling for astronauts, and host-pathogen interactions in COVID samples.

INTERCEPT Blood System for Cryoprecipitation Receives FDA Approval States Cerus Corporation

"FDA approval of the INTERCEPT Blood System for Cryoprecipitation is an important step forward in our mission to establish pathogen reduction as the standard of care for transfused blood components globally," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer.

Research Paper Showing ProtoKinetix AAGP® Enhanced Stem Cell Derived Retina Precursor Cells Restoration of Vision

ProtoKinetix notes the research paper has been submitted to a prestigious journal specializing in tissue regeneration for peer review and editing.

OrganaBio to Expand Its cGMP Cell and Gene Therapy Manufacturing Facility: 19,000 Sq. Ft. Slated to Commence Operations In Q3 2021

OrganBio, a Miami-based cGMP facility, will include process development space, ISO 7 cleanrooms, state-of-the-art scientific equipment, analytics and QC laboratories, and a suite of support services to enable OrganaBio and its partners to rapidly and economically self-manufacture clinical materials. 

Stoke Therapeutics Announces Proposed Public Offering

November 18, 2020 Stoke Therapeutics, Inc., a biotechnology company pioneering a new way to treat the underlying cause of genetic diseases by precisely upregulating protein...