Posts by rw-admin
RapidAI Receives First and Only FDA 510(k) Clearance of Non-Contrast CT Imaging Product to Accelerate Acute Stroke Triage
RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today announced it has received FDA 510(k) clearance for Rapid NCCT Stroke – a major addition to the RapidAI suite of non-contrast based solutions for stroke and trauma care, and the first and only FDA cleared medical device to detect suspected intracranial…
Read MoreCaristo Diagnostics Completes Series A Financing and Welcomes New CEO to Advance Ground-Breaking AI Technology for Cardiac Disease Detection
Caristo Diagnostics Limited, a global leader in cardiac and vascular disease diagnostics and risk prediction, today announced it has secured a further £13 million (US$16.3 million) to conclude its Series A financing round. Caristo will use the capital to advance its CaRi-Heart® technology, an AI-assisted diagnostics and risk prediction tool, into standards of cardiac care in…
Read MorePrecision Optics Appoints Mahesh Lawande as Chief Operating Officer
Precision Optics Corporation, Inc. (NASDAQ: POCI), a leading designer and manufacturer of advanced optical instruments for the medical and defense industries, today announced the appointment of medical device and aerospace/defense industry manufacturing veteran, Mahesh Lawande, as the Company’s Chief Operating Officer effective April 24, 2023. In the newly created role, Lawande will lead Precision Optics operations team, including…
Read MoreNeuvotion Secures an Additional $1.25M to Commercialize NeuStim™ Technology for Treating Stroke and Debilitating Injuries
Neuvotion, Inc. is an early-stage medical device company developing neurostimulation products for the rehabilitation, brain-computer interface, and physical therapy markets, today announced that it has received an additional $1.25M in funding, bringing cumulative funding to over $2.75M. Northwell Holdings, the venture investment arm of Northwell Health, Topspin Fund, and Long Island Angel Network also participated in the round. This…
Read MoreSentiAR Announces Close of $8.5 million Series B Financing
SentiAR, Inc. a St. Louis, Missouri based pioneer in using Augmented Reality (AR) visualization technology for medical procedures, has closed an $8.5 million Series B financing. The financing was led by cultivate (MD) Ventures and joined by MedVenture Partners alongside several insider investors, including TechWald Holding, VCapital, QRM Capital, and Harmonix Fund. The funding will allow the company to launch…
Read MoreBioVentrix® Closes $48.5 Million Series A Financing
BioVentrix, Inc., a privately held medical device company developing minimally invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process in patients with congestive heart failure, today announced the completion of $48.5 million Series A round financing. The round was led by Andera Partners, a prominent life-science venture capital investor. The…
Read MoreAbyrx Receives Additional FDA Clearances for MONTAGE® Settable, Resorbable Bone Putty as Bone Void Filler and Cranial Bone Cement
Abyrx, Inc. (http://abyrx.com), a leading biomaterial sciences company with a focus on therapeutic technologies for use during surgical procedures, today announced its receipt of additional United States Food and Drug Administration (FDA) clearances for the company’s MONTAGE® Settable, Resorbable Bone Putty as both a bone void filler and cranial bone cement. Used by surgeons across…
Read MoreFDA Authorizes Marketing of MISHA™ Knee System for People Suffering from Knee Osteoarthritis
Moximed, a medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), today announced that the U.S. Food and Drug Administration (FDA) granted marketing authorization of the MISHA™ Knee System, an implantable shock absorber (ISA) for the knee. The MISHA Knee System is indicated to treat people…
Read Morerestor3d Receives FDA Clearance of Patient Specific Resection Guides for use with the Kinos Axiom Total Ankle System
restor3d, a research-driven medical device company, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Axiom PSR System for use with the company’s Kinos Axiom Total Ankle System. The Axiom PSR (patient-specific resection) System is additively manufactured from titanium alloy, making it the first all-metal, patient-specific instrument system cleared…
Read MoreIcentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®
Icentia Inc., announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. “This approval marks a key milestone for our company. The FDA clearance opens the door to the world’s largest medical device market. With the cost effectiveness and demonstrated ability of…
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