Tele: 561.316.3330
Breaking Medical Device News

Wednesday, September 22, 2021


HomeHOSPITALSDelray Medical Center Becomes First Hospital in Florida to Use New Technology for Stroke Patients

Delray Medical Center Becomes First Hospital in Florida to Use New Technology for Stroke Patients

FDA Authorizes Software that Can Help Identify Prostate Cancer

The software is called Paige Prostate and is compatible for use with slide images that have been digitized using a scanner.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance

inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.

Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse

Under the Program, the FDA will provide the Genio® system with priority review & interaction with FDA’s experts throughout the premarket review phase until the product is commercialized in the US.

FDA Will Follow The Science On COVID-19 Vaccines For Young Children

As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents...

FDA Makes Significant Progress in Science-Based Public Health Application Review, Taking Action on Over 90% of More Than 6.5 Million ‘Deemed’ New Tobacco Products Submitted

As required by statute, a key consideration in their review of premarket tobacco product applications submitted for products like e-cigarettes is to determine whether permitting the marketing of the product would be "appropriate for the protection of the public health," taking into account the risks and benefits to the population as a whole.

NeuroOne® Medical Technologies Corporation Receives FDA 510(k) Clearance for its Evo® sEEG Electrode

"This represents yet another critical milestone met by the Company as we continue to execute our strategy.  The next steps for the Company are to expand the sEEG labeling for longer term use, which we believe will be a key part of our commercialization strategy for the Evo sEEG electrode, and complete development of an sEEG ablation electrode/probe for ablation of brain tissue and permanently implanted stimulation electrodes for patients with chronic applications such as epilepsy, Parkinson's disease and chronic back pain," said Dave Rosa, CEO of NeuroOne.

Asensus Surgical Receives FDA 510(k) Clearance for Expansion of Machine Vision Capabilities

Additional Intelligent Surgical Unit™ (ISU™) features will further extend augmented intelligence leadership in surgery.

Delray Medical Center is the first hospital in the state of Florida to use the RED 62™ Reperfusion Catheter & BENCHMARK BMX96™ for stroke patients.  Neurointerventionalist, Dr. Dennys Reyes, is the first doctor in the county to use this technology.

The RED 62™ is designed to navigate complex distal vessel anatomy and deliver powerful aspiration along with the BENCHMARK BMX96™ to remove blood clots in acute ischemic stroke patients with large vessel occlusions. In addition, it provides faster navigation and shorter times to recanalize “brain vessels”.

“The RED 62™ is engineered with some of the latest innovations in tracking and aspiration technology to address large vessel blockages from a stroke located in more challenging areas, while maximizing powerful aspiration to remove blood clots,” said Dr. Reyes.  “With the help of the BENCHMARK BMX96™ Access System, hypotube technology provides a higher stability for more complex cases when it comes to treatment of a stroke.  In addition, when performing a procedure, the catheter is designed to increase versatility and visualization designed to help offer patients the best possible outcomes.”

As a comprehensive stroke center, Delray Medical Center has advanced technology and services to help with any neurological issues.  Our hospital is a member of the Advanced Neuroscience Network, and integrated delivery system of medical professionals and hospitals focused on offering a full continuum of neurological care throughout South Florida.

“This new technology gives patients who come to our hospital for stroke care the latest in neurologic care,” said Maggie Gill, chief executive officer of the Palm Beach Health Network & Delray Medical Center.  “This hospital continues to be at the forefront when it comes to the newest medical care in our community, and the RED 62™ Reperfusion Catheter & BENCHMARK BMX96™ is no exception.”

For more information about our neurosciences program, go to or call 561-498-4440.



Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Holmes Regional Medical Center Deploys Carestream Systems to Meet a Wide Array of Diagnostic Imaging Needs

Holmes Regional Medical Center opted to outfit their R/F room with the capabilities of a fully functioning digital radiography (DR) room, as well as the standard features of a conventional R/F room, by installing a CARESTREAM DRX-Ascend system with an overhead tube in conjunction with the DRX-Excel Plus.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Our Sister Publication: Biotechnology News Magazine

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