Oct. 2, 2024 — Eko Health recently announced a new independent study from researchers at Imperial College London (Imperial) that demonstrated how AI can identify patients with significantly higher risk of experiencing major adverse cardiac events (MACE), including heart attacks and heart failure. Researchers used Eko Health's FDA-cleared and UKCA-marked Low Ejection Fraction AI to conduct the study, which reinforced the power of Eko's AI for early detection while also showing its potential to improve cardiovascular care in both clinical and remote settings.

Heart failure is a rapidly growing public health issue that can be difficult to manage on a global scale. But there are tools that exist that can improve outcomes, such as guideline-directed medical therapy (GDMT). New UCLA-led research highlights the important role that these guidelines can play in reducing mortality rates for individuals suffering from heart failure with reduced ejection fraction (HFrEF), a type of heart failure affecting an estimated 29 million people worldwide.

PHOTO CAPTION: The Elucid PlaqueIQ user interface is a fully interactive visualization of the patient’s coronary anatomy, showing specific plaque type and amount across various views to inform physician assessment of risk and patient-specific treatment pathway. The original CT image is preserved to provide further context.

 

Elucid has announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its PlaqueIQ imaging analysis software to help physicians diagnose cardiovascular disease (CVD).

Sept. 24, 2024 — Thrombolytic Science, LLC (TSI) has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for mutant prourokinase, a recombinant fibrinolytic pro-enzyme. A U.S.-based clinical trial will further confirm the safety and tolerability of TSI's novel mutant prourokinase (mproUK) in healthy volunteers.

Sept. 18, 2024 – Astellas Pharma Inc. recently announced that Digitiva, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration (FDA).

Digitiva is classified as a Class I Software as a Medical Device (SaMD) and is exempt from 510(k) premarket submission*. Digitiva is the first digital health offering from Astellas in the U.S.

Sept. 16, 2024 — Numerous social and structural factors, including immigration status, socioeconomic position and access to health care, contribute to differences in cardiovascular health and heart disease risk for Asian Americans, and these factors affect Asian ethnic subgroups in different ways, according to a new scientific statement published today in the American Heart Association’s journal, Circulation.

HIMSS will present a two-day Healthcare Cybersecurity event next month in Washington, D.C.

The Healthcare Cybersecurity Forum will take place Oct. 3 to Nov. 1, 2024, at the Renaissance Arlington Capital View hotel.

The Forum is designed for decision-makers, cybersecurity experts, technology leaders, and other healthcare professionals tasked with safeguarding health systems against cyber threats.

Sept. 16,  2024 — Biotronik has received U.S. Food and Drug Administration (FDA) labeling approval of its Selectra 3D catheter in conjunction with its Solia S lead for use in left bundle branch area pacing (LBBAP). The two products represent the first and only FDA-approved stylet-driven lead and dedicated delivery catheter system approved for LBBAP.

Sept. 16, 2024 – Shockwave Medical, Inc., part of Johnson & Johnson MedTech, has announced the full U.S. launch of the Shockwave E8 Peripheral IVL Catheter, following clearance by the U.S. Food and Drug Administration (FDA). The Shockwave E8 catheter is designed to optimize the treatment of patients with calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI).  

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