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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.

ImmunoCAP Specific IgE alpha-Gal Allergen Component Test Receives FDA Clearance

ImmunoCAP Specific IgE alpha-Gal Allergen Component Test has received U.S. Food & Drug Administration (FDA)Clearance for in vitro diagnostic use.. The news was announced today by Thermo Fischer Scientific.

According to the American Academy of Asthma, Allergy and Immunology, an allergy to alpha-Gal can cause patients to have a severe and potentially life-threatening reaction to galactose-alpha-1, 3-galactose that is found in most mammalian (red) meat. Unlike other food allergies, reactions from eating red meat may be delayed, occurring three to eight hours after eating. Symptoms range from hives and itching, to abdominal pain, nausea or vomiting. In severe cases the allergy can cause anaphylaxis which can be potentially fatal. The condition can appear in patients who have tolerated meat for many years, with researchers believing that sensitization to alpha-Gal may be the result of a bite from the lone star tick (Amblyomma americanum).

“Alpha-gal is dramatically different from other forms of food allergy,” said Thomas Platts-Mills, MD, professor of medicine and microbiology at the University of Virginia School of Medicine and a leading researcher on the topic. “Previously healthy adults can suddenly develop potentially life-threatening reactions to red meats such as beef, pork and lamb. The delayed nature of the reactions adds to the difficulty that clinicians and patients have in identifying the cause of the symptoms. This unique set of circumstances makes an accurate diagnosis critical for managing this disease.”

ImmunoCAP Specific IgE alpha-Gal Allergen Component Test is the most widely used specific IgE blood test, and its use is documented in more than 6,000 peer-reviewed publications. The tests can help identify allergic sensitization to common environmental allergens – seasonal and perennial, outdoor and indoor– as well as common food allergens such as peanut, egg and milk. The ImmunoCAP Specific IgE Stinging Insect Allergen Component tests were recently cleared by the FDA to help improve the diagnosis of bee and wasp allergies. ImmunoCAP Specific IgE blood tests, which are available in most major U.S. laboratories, can be ordered for patients of any age regardless of skin condition, current medication, disease activity or pregnancy status.

“Sensitization to the alpha-Gal carbohydrate has been notoriously difficult to measure in patients,” said Dr. Lakiea Wright, MD MAT MPH, Medical Director, US ImmunoDiagnostics at Thermo Fisher Scientific. “Skin prick testing to red meats such as beef, pork, or lamb often gives weak or negative results, which is why, based on clinical studies, quantification of IgE antibodies to alpha-Gal in the blood is the preferred diagnostic method. Information from these tests can help providers be more precise in their diagnosis and management recommendations.”

 

 

 

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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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