Biocompatibility

REMSleep Holdings Shareholder Update

Retrieved on: 
Monday, March 4, 2024

CLEARWATER, FL, March 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire - REMSleep Holdings, Inc. (OTC PINK: RMSL) gives an update on FDA process and REMSleep status.

Key Points: 
  • CLEARWATER, FL, March 04, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire - REMSleep Holdings, Inc. (OTC PINK: RMSL) gives an update on FDA process and REMSleep status.
  • We have had numerous inquiries asking for REMSleep regulatory status update.
  • REMSleep consultants are confident we will receive our 510(K) and we will never give up until we are successful.
  • REMSleep has addressed this problem by developing a novel CPAP nasal pillow interface that has been engineered to reduce pressure and enable better airflow.

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon

Retrieved on: 
Monday, August 7, 2023

The Surmodics team understood the importance of this collaboration, and we are honored to have played a part in this important PMA approval."

Key Points: 
  • The Surmodics team understood the importance of this collaboration, and we are honored to have played a part in this important PMA approval."
  • For Surmodics, we were able to integrate our biocompatibility expertise with our cardiovascular regulatory experience to create a successful outcome.
  • We thank Surmodics for trusting us to help them achieve their goals for the SurVeil™ drug-coated balloon."
  • Finally, our team enjoyed the spirit of camaraderie and candor in our working relationship with MCRA."

MCRA Expands Biocompatibility Division with Key Hire of Board-Certified Toxicologist

Retrieved on: 
Monday, July 24, 2023

Dr. More expands MCRA's biocompatibility services to include toxicological risk assessment (TRA) and other toxicology consulting services for medical devices and combination products.

Key Points: 
  • Dr. More expands MCRA's biocompatibility services to include toxicological risk assessment (TRA) and other toxicology consulting services for medical devices and combination products.
  • MCRA has hired Sharlee L. More, PhD, DABT, a board-certified toxicologist, as its Associate Director of Toxicology to support the company's growing biocompatibility service offerings for the medical device industry.
  • Dr. More will lead MCRA's new toxicology service line within the Biocompatibility Division.
  • The launch of toxicology consulting services at MCRA is an important achievement for the Biocompatibility Division.

New Microbiology and Chemistry Laboratory Gets Accredited under ISO/IEC 17025:2017

Retrieved on: 
Wednesday, May 31, 2023

TÜV SÜD America Inc., a leading provider of certification, auditing and testing services, has been accredited under American Association for Laboratory Accreditation (A2LA) ISO/IEC 17025:2017 Accreditation.

Key Points: 
  • TÜV SÜD America Inc., a leading provider of certification, auditing and testing services, has been accredited under American Association for Laboratory Accreditation (A2LA) ISO/IEC 17025:2017 Accreditation.
  • The laboratory enables domestic and international medical device companies to accelerate their research and development by providing testing services in the areas of microbiology, reusable device testing, chemistry, biocompatibility and packaging.
  • ISO/IEC 17025:2017 is the international standard for testing and calibration laboratories, and it outlines the requirements for the competence, impartiality, and validity of laboratory results.
  • A wide range of testing is covered including Chemistry, Microbiology, Water Testing, Bioburden, Biocompatibility, and Cytotoxicity.

MCRA Assists Noctrix Health with FDA Marketing Authorization via the De Novo Pathway for the NTX100 Tonic Motor Activation System

Retrieved on: 
Monday, May 8, 2023

The NTX100 TOMAC System is an externally worn medical device that applies low-level electrical stimulation to peripheral nerve fibers in the leg to treat Restless Legs Syndrome (RLS).

Key Points: 
  • The NTX100 TOMAC System is an externally worn medical device that applies low-level electrical stimulation to peripheral nerve fibers in the leg to treat Restless Legs Syndrome (RLS).
  • Noctrix Health was granted the breakthrough device designation in May 2020 for use of the NTX100 TOMAC to treat drug-refractory RLS.
  • Our De Novo submission was supported by their wealth of expertise, allowing us to receive marketing authorization in a short period of time.
  • MCRA is pleased to continue supporting neurological innovation in the medical device industry by helping clients navigate global regulatory challenges.

Global Advanced Metals and Croom Medical Collaborate to Offer Tantalum Additive Manufacturing Capability

Retrieved on: 
Thursday, February 23, 2023

WELLESLEY, Mass., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Global Advanced Metals (USA) and Croom Medical (Ireland) are collaborating to establish a turnkey tantalum-based additive manufacturing (AM) platform.

Key Points: 
  • WELLESLEY, Mass., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Global Advanced Metals (USA) and Croom Medical (Ireland) are collaborating to establish a turnkey tantalum-based additive manufacturing (AM) platform.
  • With Croom's years of successful contract manufacturing experience, the tantalum print capability is being offered by Croom as a contract manufacturing solution, bringing the advantages of tantalum to the medical device, aerospace, and related markets.
  • Based in County Limerick, Ireland, Croom Medical (Croom) has operated for more than 35 years providing contract manufacturing services to medical device (and other) OEMs.
  • Andrew O'Donovan, CEO of Global Advanced Metals, added, "GAM is thrilled to work with such an experienced and trusted company as Croom Medical.

The Worldwide Biocompatible Materials Industry is Projected to Reach $448.6 Billion by 2030: Wound Dressing Applications Increasingly Turn to Biomaterials

Retrieved on: 
Friday, February 3, 2023

DUBLIN, Feb. 3, 2023 /PRNewswire/ -- The "Biocompatible Materials - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Feb. 3, 2023 /PRNewswire/ -- The "Biocompatible Materials - Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.
  • The global market for Biocompatible Materials estimated at US$138.8 Billion in the year 2022, is projected to reach a revised size of US$448.6 Billion by 2030, growing at a CAGR of 15.8% over the analysis period 2022-2030.
  • Polymeric, one of the segments analyzed in the report, is projected to record a 17% CAGR and reach US$208.4 Billion by the end of the analysis period.
  • The U.S. Market is Estimated at $40.6 Billion, While China is Forecast to Grow at 14.7% CAGR
    The Biocompatible Materials market in the U.S. is estimated at US$40.6 Billion in the year 2022.

Biocompatibility Testing Webinar: What You Need to Know - ResearchAndMarkets.com

Retrieved on: 
Friday, October 21, 2022

The "Biocompatibility Testing: What You Need to Know" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Biocompatibility Testing: What You Need to Know" training has been added to ResearchAndMarkets.com's offering.
  • Participants will not only learn how to assess their device for Biological risks but also understand when testing is not necessary.
  • Anyone with a desire to be up to date with the current state of the art of Biocompatibility assessment.
  • Overview of current ISO 10993-1 and collateral standards Biocompatibility testing guidelines, costs, and turnaround times.

MCRA Expands Recently Formed Biocompatibility Division with 2 Key Hires from FDA and Industry

Retrieved on: 
Tuesday, August 16, 2022

As regulatory scrutiny over device biocompatibility increases, MCRA forms a world class team of biocompatibility experts from FDA and industry.

Key Points: 
  • As regulatory scrutiny over device biocompatibility increases, MCRA forms a world class team of biocompatibility experts from FDA and industry.
  • Key hires Eric M. Sussman, PhD, and Claus Svane Sndergaard, PhD,recently joined MCRA to bring further FDA and industry biocompatibility experience to MCRA's recently established division.
  • Dr. Allen, who leads MCRA's Biocompatibility Team, said "Biocompatibility is a rapidly growing area of need in the medical device industry.
  • The MCRA biocompatibility team is committed to providing clients with biocompatibility advisement that keeps up with these changing technical and regulatory expectations.

LifeNet Health LifeSciences launches new, human-relevant Cell-Based Assay Service for drug and compound discovery

Retrieved on: 
Monday, August 1, 2022

VIRGINIA BEACH, Va., Aug. 1, 2022 /PRNewswire/ -- LifeNet Health LifeSciences, a leader in all-human biomedical research solutions, is launching a new Cell-Based Assay Service following the acquisition of biotechnology firm IONTOX. These new in vitro screening options offer alternatives to animal testing that support safer, more effective novel compound discovery – providing a new level of human relevance and predictability, while furthering LifeNet Health's commitment to improve lives through the gift of donation.

Key Points: 
  • VIRGINIA BEACH, Va., Aug. 1, 2022 /PRNewswire/ -- LifeNet Health LifeSciences , a leader in all-human biomedical research solutions, is launching a new Cell-Based Assay Service following the acquisition of biotechnology firm IONTOX.
  • The new services from LifeNet Health LifeSciencesinclude:
    Cytotoxicity screening using high-quality, cell-based models with strong human relevance to identify potential adverse effects from drugs or chemicals.
  • To support this expansion, LifeNet Health LifeSciences welcomes IONTOX and its team of scientists including founder and industry leader James McKim, PhD to the LifeNet Health LifeSciences division.
  • LifeNet Health LifeSciences has grown into a leading provider of all-human cells and biospecimens for research.