Tuesday, October 3, 2023
Tuesday, October 3, 2023

Contact: 561.316.3330

ABK Biomedical Receives FDA 510(k) Clearance of Easi-Vue Embolic Microspheres

ABK Biomedical, Inc., an innovative medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces FDA 510(k) clearance of Easi-Vue embolic microspheres for the treatment of patients suffering from arteriovenous malformations and hypervascular tumors.

Arteriovenous malformations (AVMs) occur when capillaries, veins, and arteries don’t develop properly and may lead to cutaneous discoloration, sensitivity, pain, and vascular bleeding. Vascular embolization, performed by interventional radiologists, is an effective therapy for addressing the symptoms of patients suffering from this condition.

Hypervascular tumors occur in both benign and malignant states and are characterized by blood supply from an abnormally large number of blood vessels. Microspheres embolization reduces or eliminates the blood flow to these tumors and is an effective interventional radiology therapy for treating this disease state.

Aravind Arepally, MD, FSIR, and Chief Medical Officer of ABK Biomedical said

“The evolution of embolic therapies to treat these complex disease states has been notable in recent years. Now, with Easi-Vue embolic microspheres, interventional radiologists have a highly calibrated, see-and-do technology capable of visually targeted placement using conventional x-ray and fluoroscopy systems. This microspheres technology and proprietary controlled-concentration delivery system have the potential to improve patient outcomes.”

“We are excited to achieve FDA 510(k) clearance for this new technology that has the potential to advance the field of embolic therapies”, said Gary Donofrio, Chief Business Officer of ABK Biomedical. “This represents a major milestone for ABK as our team continues to execute our product development objectives. We will partner with key physicians to understand the range of clinical utilization and optimization of Easi-Vue therapy. Additionally, ABK continues to significantly advance the development program of our Eye90 microspheres® radio-embolic technology that’s being investigated for the treatment of patients with unresectable Hepatic Cellular Carcinoma (HCC). Easi-Vue embolic microspheres share core technologies and design characteristics with Eye90 microspheres. Both devices continue to add to our knowledge base regarding the clinical experience of the first glass radiopaque embolic microspheres therapy.”

Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.


4SC Receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA

Jason Loveridge, Ph.D., CEO of 4SC, commented: “Receiving orphan drug designation for resminostat provides us with a number of important benefits, most crucially 7 years’ market exclusivity in the US, a key foundation of our efforts to commercialise Kinselby.  We are currently preparing a marketing authorisation application for Kinselby in the EU, which remains on track for submission in Q1 2024.”

Abyrx Receives FDA Clearance for MONTAGE ® Settable Bone Putty for Use in Cardiothoracic Surgery

By expanding the range of FDA-cleared surgical applications for MONTAGE, this latest milestone positions Abyrx to build upon the more than 25,000 units of MONTAGE that have been used to date by surgeons in trauma, orthopedics, sports medicine, foot and ankle, and craniomaxillofacial procedures.

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

By using this website you agree to accept Medical Device News Magazine Privacy Policy