Award supports design and preclinical testing of pediatric stent SAN DIEGO, March 22, 2023 /PRNewswire/ — Starlight Cardiovascular, Inc., a medical device company developing pediatric cardiovascular devices, announced that it has been awarded a Small Business Innovation Research (SBIR) Phase II grant from the National Heart, Lung, and Blood Institute (NHLBI) of […]
Author: Ken Dropiewski
Axon Therapies Cohort Study Extends Benefit to 6 months with Early Clinical Data from REBALANCE-HF Randomized Clinical Trial
SANTA CLARA, Calif., March 22, 2023 /PRNewswire/ — Axon Therapies, a private company focused on addressing a root cause of heart failure, today announced positive 6-month results from a roll-in cohort for their feasibility IDE trial, REBALANCE-HF. The latest data is consistent with prior results previously presented for their proprietary Splanchnic Ablation for Volume Management (SAVM) […]
V-LAP Allows Heart Failure Patients to Self-Adjust Medication: Vectorious Reports Promising Findings From its Pilot Study at the THT meeting
During 89.1% of the overall follow up duration (3504 days), Patient Self-Management (PSM) alone was sufficient to stabilize HF patients within the optimal LAP thresholds, while only 10.9% of follow up time, physician intervention was required to adjust medication TEL AVIV, Israel, March 22, 2023 /PRNewswire/ — Yesterday, Vectorious Medical Technologies Ltd. presented interim […]
Semler Scientific Reports Fourth Quarter and Full Year 2022 Financial Results
2022 Q4 and Full Year highlights compared to the corresponding period of 2021: Fourth quarter revenue was $13.8 million, an increase of 20% Fourth quarter net income was $3.2 million, an increase of 113% Full year revenue was $56.7 million, an increase of 7% Full year net income was $14.3 million, a decrease of 17% […]
Tenax Announces Issuance of U.S. Patent Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Patent provides intellectual property protection until December 2040 PH-HFpEF affects more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients by 2030 There are currently no FDA approved treatments for PH-HFpEF Levosimendan combines two MoAs that, for the first time, specifically target the symptoms PH-HFpEF patients […]
FDA Approves First-in-class Evkeeza® (evinacumab-dgnb) for Young Children with Ultra-rare Form of High Cholesterol
Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH), an inherited condition characterized by extremely high low-density lipoprotein cholesterol (LDL-C) 48% reduction in LDL-C from baseline at week 24 when Evkeeza was added to other lipid-lowering therapies in the pivotal trial TARRYTOWN, N.Y., March 22, […]
Nanox.AI Expands Footprint Through New Global Partnership with Ferrum Health
Partnership with Ferrum Health offers unprecedented data security and an integrated AI platform to streamline health systems’ adoption of AI technology, such as Nanox’s Bone solution (HealthOST) and cardiac solution (HealthCCSng) NEVE ILAN, Israel, March 22, 2023 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging […]
Totality of Evidence from BeAT-HF Study Shows CVRx’s Barostim Provides Long-term Benefits for Patients with Heart Failure
MINNEAPOLIS, March 21, 2023 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing Barostim™, an innovative extravascular implantable neuromodulation device for patients with cardiovascular diseases, announced detailed preliminary results of the post-market phase of the BeAT-HF trial at the second annual […]
Viz.ai is First to Receive FDA 510(k) Clearance for AI Algorithm for Abdominal Aortic Aneurysm
New artificial intelligence algorithm flags and triages suspected abdominal aortic aneurysms SAN FRANCISCO – March 21, 2023- Viz.ai, the leader in AI-powered disease detection and intelligent care coordination, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm […]
Brainomix Receives FDA Clearance for Its Flagship Stroke AI Imaging Software
The Oxford, UK headquartered company, long established as a market leader in Europe and a pioneer in the development of innovative stroke AI solutions, is now poised to take its transformative technology to US stroke centers OXFORD, England, and CHICAGO, March 21, 2023 /PRNewswire/ — Brainomix, the AI-powered medtech solutions company, today announced that its Brainomix 360 […]
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