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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.

EVA15 Insufflator and Smoke Evacuation System Receives FDA Clearance Annouces Palliare

Palliare announced today that it has received 510k clearance from the United States FDA for its patented EVA15 insufflator and smoke evacuation system.

EVA15 is a novel insufflator designed to meet the demanding insufflation requirements of endoscopic and robotic surgery, while offering integrated surgical smoke evacuation capability, filtering the hazardous smoke particles produced during laparoscopic surgery and removing them from the operating room. The built-in smoke evacuation capability also allows EVA15 to reduce device footprint in the OR by 50 percent while significantly reducing the cost of each procedure.

“EVA15 is the optimal solution for insufflation and surgical smoke evacuation, with one device managing two of the most critical needs for these types of surgical procedures,” said Caroline O’Dea, Managing Director, Palliare. “We are excited to receive FDA 510K clearance for EVA15, marking a crucial step toward bringing this important product to market later this year.”

The dangers associated with surgical smoke inhalation have been well documented, leading recently to a number of US states passing legislation mandating the use of such smoke evacuation systems to protect the safety of operating room staff. The American Association of periOperative Registered Nurses (AORN) estimates that being in an operating room for just one day has the potential to expose operating staff to surgical smoke that is equivalent to smoking 27 to 30 unfiltered cigarettes. The EVA15 laparoscopic insufflator provides pedal-activated smoke evacuation, and has the unique capability of connecting directly to the OR scavenging system, ensuring that smoke is completely removed from the operating room and not re-circulated.

Palliare is also pleased to announce two appointments to its Board of Directors. With more than 30 years of experience in the surgical industry, Scott D. Flora will serve as Chairman of the Board. Flora recently served as CEO of Invuity prior to its acquisition by Stryker (NYSE:SYK), and has previously served as President, Global Business Unit, Surgical Devices at Covidien (NYSE:MDT). Additionally, leading Irish Medtech entrepreneur John O’Shaughnessy will serve on Palliare’s Board of Directors. John was a co-founder and Chairman of Neuravi prior to its acquisition by Johnson & Johnson (NYSE:JNJ), and co-founder and CEO of MedNova prior to its acquisition by Abbott (NYSE:ABT).

“We are delighted to have Scott Flora and John O’Shaughnessy join the Palliare Board,” said O’Dea. “Palliare will greatly benefit from their significant experience as we prepare for the EVA15 product launch.”

Latest Posts

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...