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Tuesday, September 21, 2021

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HomeShreis Scalene Therapeutics LLCShreis Scalene Therapeutics Compiles 510K Market Clearance Application for the SHYCOCAN® Device That Disables Coronaviruses

Shreis Scalene Therapeutics Compiles 510K Market Clearance Application for the SHYCOCAN® Device That Disables Coronaviruses

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.

April 19, 2021

Shreis Scalene Therapeutics LLC (SSTx), a MD-USA-based medical device company has fast-tracked the marketing and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN®), that is currently market-enabled under “US FDA’s ‘Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”

To enable uninterrupted marketability, SSTx is now compiling a 510K market clearance application for the US FDA, with regulatory support provided by EMERGO (by UL).

“Significant strides have been made by SSTx in collaboration with technology partner Scalene Cybernetics Limited, Bengaluru, India, to facilitate the submission of technical and biological validation dossiers to the regulatory bodies in neighboring countries, through its collaborative marketing and distribution partners, leading to additional marketing authorizations from Mexico’s COFEPRIS as a Class I device, Health Canada’s Class I device classification for marketing under an MDEL in Canada, and other US FDA and CE compliant countries in neighboring Latin America and Caribbean countries” said Prof. Meena Augustus Ph.D., Founder-President, CEO & CSO of SSTx.

Prof. Augustus added, “This device has been safety-certified to be deployed 24/7 in almost all enclosed indoor environments. No ultraviolet light, filter-systems, hazardous ozone, or other harmful chemical emission occurs with the SHYCOCAN®. A salient feature of this technology that has also been biologically validated, is that while viruses are targeted, beneficial bacteria, fungi or other micro-organisms, human and mammalian epithelial cells are not, making it eco-, people, and pet friendly.”

“The SHYCOCAN® with its innovative technology that delivers photoelectrons in real-time, is currently being marketed in other global regions of the world by Dr. Rajah Vijay Kumar D.Sc., in Bengaluru, India, while SSTx gears up to meet the growing demand from within N. & S. America. To continue to mass produce and market the product, SSTx is in the process of identifying internationally reputed, domestic contract manufacturing collaborations,” said Rayol John Augustus Ph.D., Co-Founder and COO of SSTx and the Founder President of the Shreis Group of Medical Device companies.

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DON'T MISS

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.

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