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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.

New England Journal Of Medicine Confirms Viability of Rory’s Regulations, Deems Sepsis “A Public Health Crisis Worthy of a Policy Response


Sepsis is a public health crisis worthy of a public policy response

The Rory Staunton Foundation for Sepsis Prevention today reported on a new study released on May 21, 2017 in the New England Journal of Medicine (NEJM) confirming that sepsis protocols in New York State hospitals are leading to expedited intervention and a steady decline in sepsis deaths. Ciaran and Orlaith Staunton, who lost their son, Rory, at twelve years old to undiagnosed and untreated sepsis, are the driving force in the adoption of New York State’s Rory’s Regulation protocols. They are now calling on state and federal officials to take action in the adoption of Rory’s Regulation protocols nationally.

Sepsis will kill upwards of 300,000 Americans in 2017 and will result in more that $20 billion in healthcare costs. Ciaran and Orlaith Staunton commented: “In light of this new evidence, we call on governors, health commissioners, and Health and Human Services Secretary, Tom Price, to adopt these protocols nationally. Families across America to date still do not know the meaning of the word ‘sepsis’, and because of that and the lack of comprehensive sepsis policy, are losing their family members in droves. It’s time to enact these lifesaving, low-cost, simple regulations in every medical institution in the country. Constituents should hold their elected officials accountable and ask them why they are allowing this crisis to continue when it is within their power to prevent it.”

The NEJM study, co-authored by Dr. Chris Seymour, assistant professor at the University of Pittsburgh, and Dr. Mitchell Levy, a physician and professor at Brown University’s medical school, examines data from New York and confirms that the sepsis regulations adopted in 2013 led to faster care and increased chances of survival for sepsis patients. Rory’s Regulations, require hospitals to follow a checklist of steps within the critical three hour window; including blood tests, checking blood lactate levels (a marker for sepsis) and beginning antibiotics. The faster hospitals completed the checklist, the lower the risk of death.

Sepsis is the body’s overwhelming reaction to infection. It causes inflammation, damages tissue, and leads to organ failure and death. The Stauntons established the Rory Staunton Foundation for Sepsis Prevention following their son’s death and actively campaign for the adoption of sepsis protocols in every state by 2020. Illinois adopted regulations in 2016 and Pennsylvania is moving to do so this year with more states to follow. The new study should bolster support for the regulations–and the Stauntons and their supporters will continue to fight at the state and national level until every hospital in the country operates with a sepsis protocol in place. None other than Atul Gawande, the physician, bestselling author of The Checklist Manifesto, and author of the World Health Organization’s Surgical Safety Checklist hailed the progress made by New York State as “impressive and important.” He added, “It’s real evidence that time matters.”

April 1st represented the fifth year since Rory’s Staunton’s death. “We are not going away. We demand a systemic change within our nation’s healthcare system. The most respected and recognized medical journal concurs with the benefits of Rory’s Regulations. The suggested ‘policy response’ is long overdue,” Orlaith Staunton concluded.

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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.” 

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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