Food and Drug Administration

USA-Based ZetrOZ Systems Selected by the National Institute of Aging to Present the Sustained Acoustic Medicine (SAM) Medical Product Portfolio to Global Healthcare Community

Thursday, September 17, 2020 - 11:31pm

TRUMBULL, Conn., Sept. 17, 2020 /PRNewswire/ --ZetrOZ Systems, a leading USA-based medical device manufacturer, was selected by the National Institute of Aging to present its product portfolio on opioid/surgery free medical technology, also known as Sustained Acoustic Medicine, or SAM.

Key Points: 
  • TRUMBULL, Conn., Sept. 17, 2020 /PRNewswire/ --ZetrOZ Systems, a leading USA-based medical device manufacturer, was selected by the National Institute of Aging to present its product portfolio on opioid/surgery free medical technology, also known as Sustained Acoustic Medicine, or SAM.
  • The wearable technology provides deep sustained cellular activation and delivers vigorous multi-hour treatment accelerate natural healing of common musculoskeletal injuries.
  • The lead product configuration, SAM 2.0 with gel-capture patches, are approved by the Food and Drug Administration (FDA) 2020 for prescription home-use.
  • ZetrOZ Systems is an FDA cGMP and ISO 13585 medical technology company headquartered in the southern coastal region of Connecticut.

Teleorthodontic Company Grin Launches Remote Monitoring Platform

Thursday, September 17, 2020 - 4:00pm

The Grin experience consists of the Grin App and Grin Scope, which is an FDA listed medical device.

Key Points: 
  • The Grin experience consists of the Grin App and Grin Scope, which is an FDA listed medical device.
  • Together, under the supervision of partner orthodontists, Grin will provide a suite of capabilities including the Grin Remote Monitoring Platform for teeth straightening.
  • The collaboration includes a COVID-19 initiative, where 3M will distribute complimentary Grin systems to assist orthodontists across the United States in need of remote monitoring solutions during the pandemic.
  • Grin gives patients maximum convenience and cost-effective remote monitoring solutions that keep orthodontists in the care loop, said Grin CEO Adam Schulhof, DMD.

ArcherDX to Present at Cowen's 2020 Liquid Biopsy Summit

Thursday, September 17, 2020 - 2:00pm

IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA.

Key Points: 
  • IVD products currently in development for solid tumor biomarker identification and Personalized Cancer Monitoring (PCM) have both received Breakthrough Device Designation from the FDA.
  • Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors.
  • ArcherDX has based these forward-looking statements largely on its current expectations and projections about future events and trends.
  • ArcherDX undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law.

Avadel to Present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

Thursday, September 17, 2020 - 1:00pm

In addition, management will be participating in one-on-one meetings with investors who are registered to attend the conference.

Key Points: 
  • In addition, management will be participating in one-on-one meetings with investors who are registered to attend the conference.
  • Avadel Pharmaceuticals plc (Nasdaq: AVDL) is an emerging biopharmaceutical company.
  • FT218 has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of narcolepsy.
  • In particular, FT218 may be safer due to ramifications associated with the dosing regimen of the previously approved product.

Global $22 Billion Leukemia Drug Market to 2025: Partnerships & Collaborations, 633 Clinical Trials, 77 Marketed Drugs, Availability, Dosage & Price Analysis

Thursday, September 17, 2020 - 12:00pm

DUBLIN, Sept. 17, 2020 /PRNewswire/ -- The "Global Leukemia Drug Market, Drug Price, Patent, Dosage & Clinical Trials Insight 2025" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Sept. 17, 2020 /PRNewswire/ -- The "Global Leukemia Drug Market, Drug Price, Patent, Dosage & Clinical Trials Insight 2025" report has been added to ResearchAndMarkets.com's offering.
  • "Global Leukemia Drug Market, Drug Price, Patent, Dosage & Clinical Trials Insight 2025" offers comprehensive insights on the various clinical and non-clinical parameters responsible for growth of global leukemia drug market.
  • The emergence of new technological innovations in clinical research and drug development methodologies has led to the desired thrust to the market in recent years.
  • There are more than 600 drugs in clinical trials and more than 70 drugs are commercially available in the market.

With New EUA, Color's COVID-19 Self-Collection Kit Enables Public Health and Large Private Labs to Increase Access to Testing

Wednesday, September 16, 2020 - 5:23pm

This authorization by the FDA combines several developments by Color that, in concert, are designed to substantially increase cost-effective and convenient access to COVID-19 testing.

Key Points: 
  • This authorization by the FDA combines several developments by Color that, in concert, are designed to substantially increase cost-effective and convenient access to COVID-19 testing.
  • For example, some of the largest university testing programs in the country at institutions utilize Color's process to offer testing to students and staff.
  • Color's self-swab kit is already being used by universities, public health institutions, and employers to carry out frequent testing for large COVID-19 testing programs across the country
    "Our kit brings a new resource to institutions looking to scale COVID-19 testing for public health," said Color Chief Science Officer Alicia Zhou.
  • Color works with health systems, employers, and national health initiatives around the world including the million-person All of Us Research Program by the National Institutes of Health.

Managing External Data Sources in Clinical Trials: Current and Future Strategies, Upcoming Webinar Hosted by Xtalks

Wednesday, September 16, 2020 - 1:30pm

TORONTO, Sept. 16, 2020 /PRNewswire-PRWeb/ -- As clinical trials are incorporating an increasing number of sources of non-case-report-form (CRF) data from wearable devices and various laboratories, management of clinical data must address larger, disparate volumes of external data sources.

Key Points: 
  • TORONTO, Sept. 16, 2020 /PRNewswire-PRWeb/ -- As clinical trials are incorporating an increasing number of sources of non-case-report-form (CRF) data from wearable devices and various laboratories, management of clinical data must address larger, disparate volumes of external data sources.
  • These non-CRF clinical data can cause delays in resolving queries and can place additional burden on eCRF data managers.
  • In this webinar, our thought leaders discuss best practices for dealing with these complex data structures and implementing a data strategy that not only addresses needs for today, but also explores future tactics for proactively optimizing management of external data sources.
  • For more information or to register for this event, visit Managing External Data Sources in Clinical Trials: Current and Future Strategies .

FDA Granted Pediatric Disease Designation for OXi-4503

Wednesday, September 16, 2020 - 2:00pm

We are excited about this Rare Pediatric Disease designation for AML, said Dr. Vuong Trieu, Chief Executive Officer of Mateon.

Key Points: 
  • We are excited about this Rare Pediatric Disease designation for AML, said Dr. Vuong Trieu, Chief Executive Officer of Mateon.
  • This builds on our previous Rare Pediatric Disease designations for OT-101 and CA4P.
  • The FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S.
  • Mateon has rare pediatric designation for DIPG (CA4P) and melanoma (CA4P).

Eton Pharmaceuticals Provides Update on the FDA Review of EM-100

Wednesday, September 16, 2020 - 2:00pm

The company is not aware of any information requests outstanding and expects the FDA to communicate a decision shortly.

Key Points: 
  • The company is not aware of any information requests outstanding and expects the FDA to communicate a decision shortly.
  • Eton Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing, acquiring, and commercializing innovative products.
  • The companys first commercial product, Biorphen, is the only FDA approved ready-to-use formulation of phenylephrine injection and was launched in December 2019.
  • The companys lead pediatric product is the orphan drug Alkindi Sprinkle, which is currently under review with the FDA.

MediWound Announces FDA Acceptance of Biologics License Application for NexoBrid for the Treatment of Severe Thermal Burns

Wednesday, September 16, 2020 - 12:30pm

In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
  • The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S.
  • Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and/or full-thickness thermal burns up to 30% of total body surface area.
  • Vericel Corporation (NASDAQ: VCEL) holds an exclusive license for North American commercial rights to NexoBrid.