US FDA

Stem Cell Therapy Market Worth $615 Million | MarketsandMarkets

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Tuesday, December 12, 2023
Microsoft Exchange Server, DSM-IV codes, Research, Prevalence, Takeda Pharmaceutical Company, IND, RTI Surgical, Investment, NuVasive, Market development, Patient, ALS, PVT, COVID-19, Stem cell, Master of ceremonies, US FDA, Technical, Cancer, Pulse, RESEARCH, Growth, Embryonic stem cell, Ethics, Adipose tissue, Silk, Veterinary medicine, Pharmaceutical industry

The global stem cell therapy market is segmented into adipose tissue-derived MSCs, bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources.

Key Points: 
  • The global stem cell therapy market is segmented into adipose tissue-derived MSCs, bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources.
  • Stem Cell Therapy Market Dynamics:
    Key Market Players of Stem Cell Therapy Industry:
    The stem cell therapy market is competitive, with a small number of players competing for market shares.
  • Stem Cell Therapy Market - Key Benefits of Buying the Report:
    The report will help market leaders/new entrants by providing them with the closest approximations of the revenue numbers for the overall stem cell therapy market and its subsegments.
  • The report provides insights on the following pointers:
    Analysis of key drivers (Increased funding for stem cell research, rise in collabrations and partnerships is likley to uplift the market growth, Increasing clinical trials for stem cell based-therapies), restraints ( Ethical concerns related to embryonic stem cells, high cost of cell-based research), opportunities (The emergence of iPSCs as an alternative to ESCs, growing demand for stem cell and gene therapy) and challenges (Technical limitations) are influencing the growth of stem cell therapy market.

DiaCarta Launches OTC at Home Fecal Occult Blood Test to Complement its ColoScape™ Test

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Tuesday, December 5, 2023
Colorectal cancer, Patient, Medicine, Large intestine, FOBT, Blood, US FDA, Cancer, Fecal occult blood, Methylation, Biomarker, OTC, Colonoscopy, Medical imaging

Colorectal cancer is the third most frequent cancer worldwide, emphasizing the critical need for early and effective diagnostic screening methods.

Key Points: 
  • Colorectal cancer is the third most frequent cancer worldwide, emphasizing the critical need for early and effective diagnostic screening methods.
  • DiaCarta is at the forefront of meeting this challenge with the introduction of its advanced iColon FOBT, offering a non-invasive product for early detection of blood in stool at home.
  • The iColon FOBT complements DiaCarta's highly sensitive ColoScape™ Test for qualitative early detection of colorectal cancer-associated mutation and methylation diagnostic biomarkers in circulating blood.
  • "We are excited to introduce our Fecal Occult Blood Test as a significant leap forward in the field of colorectal cancer screening," said Adam (Aiguo) Zhang CEO of DiaCarta.

Evolution Optiks Successfully Completes Data Collection in Clinical Study of Neuro-Optical Testing Device

Retrieved on: 
Tuesday, December 5, 2023
Medicine, Brain, Safety, Decon, Head, Optometry, Patient, DSM-IV codes, Binocular vision, FDA, Neuro, Advertising, Data collection, Rehabilitation, US FDA, Diagnosis, Trial of the century, Accident

CHRIST CHURCH, Barbados, Dec. 5, 2023 /PRNewswire/ -- Evolution Optiks Limited , a privately held company and forerunner in light field technology, announced today the successful completion of data collection in a US FDA-authorized clinical study to assess the safety and efficacy of its DeCon device for the evaluation of human vestibular disorders.

Key Points: 
  • CHRIST CHURCH, Barbados, Dec. 5, 2023 /PRNewswire/ -- Evolution Optiks Limited , a privately held company and forerunner in light field technology, announced today the successful completion of data collection in a US FDA-authorized clinical study to assess the safety and efficacy of its DeCon device for the evaluation of human vestibular disorders.
  • The study findings will be included in the application to the FDA to support the request for approval which the company currently expects to obtain in the first quarter of 2024.
  • "The results are very promising and we look forward to sharing the final analysis with the neuro-ophthalmological community."
  • Founded in 2014, Evolution Optiks Limited is commercializing an extensive and ongoing portfolio of innovation and is on track to revolutionizing how digital information is being consumed.

Evolution Optiks Successfully Completes Data Collection in Clinical Study of Neuro-Optical Testing Device

Retrieved on: 
Tuesday, December 5, 2023
Medicine, Brain, Safety, Decon, Head, Optometry, Patient, DSM-IV codes, Binocular vision, FDA, Neuro, Advertising, Data collection, Rehabilitation, US FDA, Diagnosis, Trial of the century, Accident

CHRIST CHURCH, Barbados, Dec. 5, 2023 /PRNewswire/ -- Evolution Optiks Limited , a privately held company and forerunner in light field technology, announced today the successful completion of data collection in a US FDA-authorized clinical study to assess the safety and efficacy of its DeCon device for the evaluation of human vestibular disorders.

Key Points: 
  • CHRIST CHURCH, Barbados, Dec. 5, 2023 /PRNewswire/ -- Evolution Optiks Limited , a privately held company and forerunner in light field technology, announced today the successful completion of data collection in a US FDA-authorized clinical study to assess the safety and efficacy of its DeCon device for the evaluation of human vestibular disorders.
  • The study findings will be included in the application to the FDA to support the request for approval which the company currently expects to obtain in the first quarter of 2024.
  • "The results are very promising and we look forward to sharing the final analysis with the neuro-ophthalmological community."
  • Founded in 2014, Evolution Optiks Limited is commercializing an extensive and ongoing portfolio of innovation and is on track to revolutionizing how digital information is being consumed.

Accorto Regulatory Solutions and Inter Scientific Enter Strategic Alliance to Deliver an Integrated Single-Point Solution for Clients

Retrieved on: 
Tuesday, November 28, 2023
NDA, Safety, MDR, ISO, Medicine, FDA, Nicotine, US FDA, APPH, Publishing, News, Public, Medical device, Industrial design, Management

RICHMOND, Va. and LIVERPOOL, England, Nov. 28, 2023 /PRNewswire/ -- Accorto Regulatory Solutions, LLC.

Key Points: 
  • RICHMOND, Va. and LIVERPOOL, England, Nov. 28, 2023 /PRNewswire/ -- Accorto Regulatory Solutions, LLC.
  • The two companies aspire to use this alliance to streamline the regulatory application development process on behalf of global clients, providing a market leading turn-key solution for both regulatory support and associated analytical data development.
  • Inter Scientific co-founder David Lawson said, "We are thrilled to unveil our strategic alliance with Accorto.
  • "We are continuously looking for opportunities to add value to the services we provide, and having trusted partners like Inter Scientific allows us to do just that."

Accorto Regulatory Solutions and Inter Scientific Enter Strategic Alliance to Deliver an Integrated Single-Point Solution for Clients

Retrieved on: 
Tuesday, November 28, 2023
NDA, Safety, MDR, ISO, Medicine, FDA, Nicotine, US FDA, APPH, Publishing, News, Public, Medical device, Industrial design, Management

RICHMOND, Va. and LIVERPOOL, England, Nov. 28, 2023 /PRNewswire/ -- Accorto Regulatory Solutions, LLC.

Key Points: 
  • RICHMOND, Va. and LIVERPOOL, England, Nov. 28, 2023 /PRNewswire/ -- Accorto Regulatory Solutions, LLC.
  • The two companies aspire to use this alliance to streamline the regulatory application development process on behalf of global clients, providing a market leading turn-key solution for both regulatory support and associated analytical data development.
  • Inter Scientific co-founder David Lawson said, "We are thrilled to unveil our strategic alliance with Accorto.
  • "We are continuously looking for opportunities to add value to the services we provide, and having trusted partners like Inter Scientific allows us to do just that."

BrainStorm Cell Therapeutics Announces In-Person Meeting with the FDA to Discuss Confirmatory Phase 3 Trial for NurOwn® in ALS

Retrieved on: 
Monday, November 20, 2023
Brainstorm, ALS, US Foods, FDA, Marketing, Therapy, US FDA, SPA, Biologics license application, Pharmaceutical industry, Agency

NEW YORK, Nov. 20, 2023 /PRNewswire/ --BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the US Food & Drug Administration (US FDA) has granted the company a meeting to discuss the regulatory path forward for NurOwn® in amyotrophic lateral sclerosis (ALS). The meeting is scheduled to take place on December 6, 2023.  Brainstorm will discuss plans for a Special Protocol Assessment (SPA) with the FDA to agree on the overall protocol design for a confirmatory Phase 3 trial in ALS.

Key Points: 
  • The meeting is scheduled to take place on December 6, 2023.
  • Brainstorm will discuss plans for a Special Protocol Assessment (SPA) with the FDA to agree on the overall protocol design for a confirmatory Phase 3 trial in ALS.
  • "We are pleased that the FDA has granted this expedited in-person meeting to discuss the best path forward for NurOwn for ALS," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm.
  • "Our proposed plan is to conduct a confirmatory Phase 3b trial and it is important that we are aligned with the Agency on the expected requirements for re-submitting a Biologics License Application.

Revelle Aesthetics Receives First International Clearance in Australia for its Avéli® Cellulite Device

Retrieved on: 
Tuesday, November 14, 2023
Woman, SEPTA, Depression, Safety, Cellulite, Patient, Adipose tissue, Buttocks, US FDA, Dermis, Ligamentous laxity, Skin, Society, Femtech

MOUNTAIN VIEW, Calif., Nov. 14, 2023 /PRNewswire/ -- Revelle Aesthetics, a VC-backed Silicon Valley FemTech company, today announced that Avéli®, its US FDA-cleared device for long-term reduction in the appearance of cellulite, has received its first international clearance in Australia, one of the largest market opportunities for cellulite outside of the United States.

Key Points: 
  • MOUNTAIN VIEW, Calif., Nov. 14, 2023 /PRNewswire/ -- Revelle Aesthetics , a VC-backed Silicon Valley FemTech company, today announced that Avéli®, its US FDA-cleared device for long-term reduction in the appearance of cellulite, has received its first international clearance in Australia, one of the largest market opportunities for cellulite outside of the United States.
  • "Cellulite is one of the most common skin conditions, prevalent in up to 90% of women1 worldwide.
  • "With our Australian clearance, we establish our global footprint and look forward to bringing a real cellulite solution to women around the world."
  • Avéli is a first-of-its-kind device that delivers a meaningful reduction in cellulite dimples after a single in-office procedure by treating cellulite at its source.

87.5% ORR | Abbisko presented two clinical updates of Pimicotinib at the 2023 CTOS Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023
PD, US, BTD, TGCT, Priority, Human, European Medicines Agency, IDMC, Male, Liver injury, Hip, BIRC, Ankle, PRO, Pain, IRC, Completeness, Part Two, Response evaluation criteria in solid tumors, QD, 1.1, MRI, Itch, AST, US FDA, CSF1, Motion, Rash, Neoplasm, Independent Review Committee, PK, ORR, Part, Safety, Therapy, ALT, Patient, LDH, ASCO, PDGFR, Contraindication, Nilotinib, III, DOR, Imatinib, Breakthrough therapy, Clinical trial, Hepatotoxicity, Knee, FDA, Dyslipidemia, CPK, RES, SD, RECIST, Pharmaceutical industry, Nursing

SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.

Key Points: 
  • SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib（ABSK021）were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.
  • The two clinical updates include reporting the design of the pivotal global multi-center phase III clinical trial and the further update of the phase Ib clinical trial of pimicotinib.
  • In 2023, the U.S. FDA conferred Breakthrough Therapy Designation and the European Medicines Agency granted Priority Medicine Designation upon Pimicotinib treatment of TGCT.
  • Here, we report the phase 1b safety and efficacy results of Pimicotinib in TGCT patients over a 1-year follow-up.

FDA (Food and Drug Administration) Approval Process for Medical Devices Online Training Course - ResearchAndMarkets.com

Retrieved on: 
Thursday, November 2, 2023
FDA, Health, Medical Devices, Mission, HDE, Food, US FDA, Legislation, Clinical Establishments (Registration and Regulation) Act, 2010, Medical device, PMA, Research, De novo, History, IDE, Food and Drug Administration, Classification, Marketing, Device

The "FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course" has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course" has been added to ResearchAndMarkets.com's offering.
  • This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States.
  • Participants will also learn about the pre-submission process, which FDA strongly recommends to help ensure the successful submission of novel devices.
  • Management, legal, medical, marketing and other professionals who are interested in understanding the key principles of the medical device approval process will also benefit in attending.