Medical Device News Magazine

FreMon Scientific Announces FDA Clearance of ZipThaw™

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

FreMon Scientific is pleased to announce the FDA has now cleared ZipThaw™ for frozen plasma thawing as a Class II medical device. ZipThaw, used with the ZipSleeve™ anti-contaminant disposable barrier, is the world’s first dry and portable precision plasma thawing system. Clinicians can now deliver vital plasma to patients at the right time and temperature.

ZipThaw and ZipSleeve have earned CE Mark, ISO certification, UL Listing and now FDA clearance for thawing fresh frozen plasma (FFP) and plasma frozen within 24 hours after phlebotomy (FP24).

We are delighted with the FDA’s clearance of ZipThaw as an effective and safe plasma thawing device for clinical use,” said FreMon Scientific CEO Dr. Farideh Bischoff.

“ZipThaw delivers plasma to patients requiring transfusions, and with ZipSleeve’s patented sensors, the system gives accurate, degree-by-degree measurement of the specimen’s actual temperature during the thawing process, not its surroundings. Today marks a new era in plasma thawing for patients, clinicians, and researchers seeking a more effective approach that is efficient, reproducible and safe.”

In most of the world, blood banks thaw plasma using hot water baths. The water baths are heavy, they require significant bench space, they are difficult to keep clean and often lead to waste since clinicians have to pre-order thawed plasma from a central location. They also only measure ambient water temperature, not the specimen’s actual temperature.

FreMon Scientific has designed the next generation thawing device that is safe, dry, easy to use, light enough to carry, and that uses a disposable, medical-grade sleeve to reduce contamination and increase accuracy. ZipThaw is proven to preserve coagulation factors needed in life saving transfusion procedures.

ZipThaw requires nearly no maintenance, thawing is precisely measured and the end-to-end thawing process is easier to manage with fewer technical staff.

“We are excited to start the new year with the opportunity to provide clinicians with an effective device that can improve their patients’ lives,” says CEO Dr. Bischoff.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. 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 objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

Shoulder Innovations Further Strengthens IP Portfolio in Key Areas with Recent Patent Grants

"These recent grants further strengthen key patent families that are foundational to our technology, and we are pleased the USPTO continues to recognize our meaningful innovation in the shoulder arthroplasty segment," said Rob Ball, CEO of Shoulder Innovations. "This noteworthy expansion of our IP position represents the culmination of over 10 years of research and development, and we are proud of our team for their continued dedication to creating practical solutions for shoulder surgeons and advancing patient outcomes."

Radical Catheter Technologies Presents Analysis of Disruptive, Recently FDA-Cleared Endovascular Technology at the Society of NeuroInterventional Surgery 21st Annual Meeting

This new catheter, the first product commercialized from this novel technology platform, is designed to enable access to the blood vessels in the brain for both femoral and radial access. A multi-center analysis of this disruptive technology is being presented today at Society of NeuroInterventional Surgery 21st annual meeting. In addition, the Company confirmed the closing of a $20 million financing round led by NeuroTechnology Investors, which will be used to scale the company and expand the Radical platform notes Radical Catheter Technologies.

Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution

“With DRIVEWIRE, our design goal was to bring new levels of access and control to the interventional suite while improving best-in-class guidewires,” comments Giora Kornblau, Chief Technology Officer at Rapid Medical. “When physicians are looking for technologies that increase the clinical possibilities and safety for the patient, we want Rapid to be the first place they look.”