Investigational device exemption

Abbott Receives FDA Approval for World's First Dual Chamber Leadless Pacemaker

Retrieved on: 
Wednesday, July 5, 2023
Heart, Communication, Investigational device exemption, Arrhythmia, Metal electrode leadless face, The New England Journal of Medicine, Lead, AAA, Physician, Engineering, IDE, FDA, Health, Medtech, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Safety, Medical device

"In delivering a true dual chamber leadless pacemaker system, Abbott is expanding access to the benefits of leadless pacing to far more people than ever before and provided additional options to improve our ability to treat people with slow or abnormal heart rhythms."

Key Points: 
  • "In delivering a true dual chamber leadless pacemaker system, Abbott is expanding access to the benefits of leadless pacing to far more people than ever before and provided additional options to improve our ability to treat people with slow or abnormal heart rhythms."
  • Through Abbott's proprietary i2i™ communication technology, AVEIR DR devices provide synchronized or coordinated cardiac pacing between two leadless pacemakers based on the person's clinical needs.
  • The i2i technology utilizes high-frequency pulses to relay messages via the naturally conductive characteristics of the body's blood between each leadless pacemaker.
  • The FDA approval of the AVEIR DR dual chamber leadless pacemaker system comes on the heels of recent late-breaking clinical data published in The New England Journal of Medicine showing that AVEIR DR system met its three prespecified primary endpoints for safety and efficacy.

New Data at Cure SMA Highlight Potential Benefit of SPINRAZA® (nusinersen) in Infants and Toddlers with Unmet Clinical Needs After Gene Therapy

Retrieved on: 
Friday, June 30, 2023
Biogen, SMA, Interim, Investigational device exemption, SMN2, Alcyone and Ceyx, Aes, BIIB, Research, Meta-analysis, Brain cell, Trial of the century, HIV disease progression rates, Patient, Therapy, RESPOND, Nusinersen, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Caregiver, Safety, Medical device, Pharmaceutical industry

(Nasdaq: BIIB) announced new SPINRAZA® (nusinersen) data aimed at answering critical questions for the spinal muscular atrophy (SMA) community.

Key Points: 
  • (Nasdaq: BIIB) announced new SPINRAZA® (nusinersen) data aimed at answering critical questions for the spinal muscular atrophy (SMA) community.
  • No new emerging safety concerns have been identified in enrolled participants who received SPINRAZA after Zolgensma.
  • “The RESPOND study has begun to characterize remaining unmet need in some SMA patients treated with Zolgensma whose outcomes have not met clinical expectations.
  • This summer, Alcyone plans to begin initial enrollment of the PIERRE study ( clinicaltrials.gov ), which will evaluate the safety and performance of ThecaFlex for the delivery of SPINRAZA in SMA patients.

Alcyone Therapeutics Receives FDA IDE Approval to Initiate Clinical Study of the ThecaFlex DRxTM System for Administration of SPINRAZA® (nusinersen)

Retrieved on: 
Tuesday, June 27, 2023
SMA, Investigational device exemption, Biogen, Biotechnology, Boston Children's Hospital, BIIB, DSM-IV codes, Cerebrospinal fluid, Harvard Medical School, Patient, ASO, CSF, Hospital, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nusinersen, Memory, Food, Safety, Scoliosis, Pharmaceutical industry, Alcyone and Ceyx

The PIERRE pivotal study ( https://clinicaltrials.gov/ct2/show/NCT05866419 ) will enroll up to 90 patients and will be conducted in two stages.

Key Points: 
  • The PIERRE pivotal study ( https://clinicaltrials.gov/ct2/show/NCT05866419 ) will enroll up to 90 patients and will be conducted in two stages.
  • "Alcyone is excited to begin the process of evaluating the safety and performance of ThecaFlex in SMA patients being treated with SPINRAZA.
  • ThecaFlex represents the culmination of a deliberate effort to design a delivery system specifically for repeat bolus intrathecal drug delivery," said PJ Anand, Chief Executive Officer of Alcyone.
  • The results of the PIERRE study to evaluate ThecaFlex with SPINRAZA in SMA may inform pathways for Biogen's broader portfolio of investigational ASO therapies.

OpGen Presents Unyvero Urinary Tract Infection Panel Trial Results at ASM Microbe 2023 Conference

Retrieved on: 
Tuesday, June 20, 2023
Communication, University, De novo, Classification, UTI, Culture, Infection, Clinical trial, System, ASM, Research, Federal, Nadine Opgen-Rhein, Investigational device exemption, Medicine, ITI, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Microbiology, Medical imaging, Vaccine

OpGen’s Unyvero UTI panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens.

Key Points: 
  • OpGen’s Unyvero UTI panel tests for a broad range of bacterial and fungal pathogens as well as antimicrobial resistance markers directly from urine specimens.
  • OpGen is seeking marketing authorization for its Unyvero UTI panel.
  • “Our data demonstrated that the Unyvero UTI panel covered nearly 94% of all organisms identified in standard of care microbiology culture.
  • Performance characteristics for this device have not yet been established and the FDA has not yet cleared the panel.

Microbot Medical Announces Multiple Peer Reviewed Abstracts Accepted by The Cardiovascular and Interventional Radiological Society of Europe

Retrieved on: 
Friday, June 16, 2023
Abstract, KOL, Cardiovascular and Interventional Radiological Society of Europe, Validation, Investigation, Disposable product, ICR, ZEUS robotic surgical system, Internet, Clinical trial, Compact, CIRSE, Circulatory system, V&V, FIH, IDE, FDA, Conference, Investigational device exemption, Safety, Medical device, Robotics

Further displaying their positive experiences and satisfaction, the Company has been informed that two peer-reviewed abstracts have been accepted to be presented at the Annual Congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).

Key Points: 
  • Further displaying their positive experiences and satisfaction, the Company has been informed that two peer-reviewed abstracts have been accepted to be presented at the Annual Congress of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
  • In addition, one of the abstracts was accepted as an oral presentation.
  • These peer-reviewed abstracts follow the highly successful extended joint pre-clinical animal studies held at leading European-based research labs by a team of seven renowned European interventional radiologists.
  • We believe that the current and future peer-reviewed data will accelerate adoption of LIBERTY once commercialized," said Dr. Eyal Morag, Chief Medical Officer of Microbot Medical.

Virtual Incision Announces MIRA’s Clinical Trial Results Will Be Presented at the 2023 ASCRS Scientific Meeting

Retrieved on: 
Wednesday, May 31, 2023
Technology, FDA, Health, Robotics, Health Technology, Medical Devices, Research, Surgery, Science, Hardware, Clinical Trials, Investigational device exemption, Surgeon, De novo, Marketing, Main Line Health, Clinical trial, Lankenau Medical Center, ASCRS, Lankenau Institute for Medical Research, American Society of Colon and Rectal Surgeons, Colorectal surgery, Hospital, RAS, MIRA, IDE, Society, Medical research, Safety, Dentistry

Virtual Incision Corporation , the developer of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced that the data from its Investigational Device Exemption (IDE) clinical trial will be presented at the 2023 American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting in Seattle, WA.

Key Points: 
  • Virtual Incision Corporation , the developer of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced that the data from its Investigational Device Exemption (IDE) clinical trial will be presented at the 2023 American Society of Colon and Rectal Surgeons (ASCRS) Annual Scientific Meeting in Seattle, WA.
  • The study was designed to evaluate the safety and efficacy of MIRA for use in bowel resection procedures.
  • John Marks will unveil the full patient data set to his peer group for the very first time,” said John Murphy, president and chief executive officer of Virtual Incision.
  • Virtual Incision is the first RAS developer to complete a U.S. IDE study to support a De Novo request in bowel resection.

ABK Biomedical Announces FDA IDE Approval for a Multi-Center Pivotal Study of Eye90 microspheres® in Hepatocellular Carcinoma

Retrieved on: 
Tuesday, May 30, 2023
Investigational device exemption, Hepatocellular carcinoma, ABK, Research, Radiation therapy, MD, Patient, NS, Principal, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Microparticle, HCC, Food, Safety, Medical device, Medical imaging

The pivotal clinical study, Route90, is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Carcinoma (HCC).

Key Points: 
  • The pivotal clinical study, Route90, is designed to evaluate the safety and efficacy of Eye90 microspheres in patients living with unresectable Hepatocellular Carcinoma (HCC).
  • The Route90 study will evaluate HCC tumors' response rates and duration of response from Eye90 microspheres treatment as co-primary endpoints.
  • "We're motivated to begin this pivotal study and assess the Eye90 microspheres technology in a large well-controlled, well-designed study.
  • Mike Mangano, President, and CEO, ABK Biomedical , said: "FDA approval of this pivotal study is a significant milestone for ABK.

Lahey Hospital & Medical Center Agrees to become One of the U.S. Sites for the LIBERTY® Robotic System’s First Human Trial

Retrieved on: 
Thursday, May 25, 2023
The Hague, Institutional review board, Investigational New Drug, ZEUS robotic surgical system, Clinical trial, IRB, Medical Center, Trial, Investigational device exemption, Lahey Hospital & Medical Center, Faculty, IDE, FDA, Health, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Medical device, Pharmaceutical industry

HINGHAM, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT) announced that it has successfully achieved another major milestone representing the next step toward the regulatory and commercial paths for the LIBERTY® Robotic Surgical System, the first single-use endovascular robotic system. Lahey Hospital & Medical Center, a world-renowned tertiary academic medical center based in Burlington, Mass., is now expected to be one of the U.S. sites for the first-ever human trial of the LIBERTY Robotic Surgical System. Microbot Medical will work closely with the research team and physician faculty at Lahey to support innovative ways to improve patient care using the LIBERTY Robotic Surgical System.   

Key Points: 
  • Lahey Hospital & Medical Center, a world-renowned tertiary academic medical center based in Burlington, Mass., is now expected to be one of the U.S. sites for the first-ever human trial of the LIBERTY Robotic Surgical System.
  • Microbot Medical will work closely with the research team and physician faculty at Lahey to support innovative ways to improve patient care using the LIBERTY Robotic Surgical System.
  • “This is another meaningful milestone for Microbot Medical, and clearly demonstrates that we are taking the necessary steps toward future commercialization of the LIBERTY Robotic Surgical System,” commented Harel Gadot, Chairman, President & CEO of Microbot Medical.
  • “We believe our continued momentum and the performance of the system, along with the rigorous process we are adhering to, has made today’s development possible.

cultivate(MD) Capital Funds Portfolio Company Virtual Incision Submits FDA De Novo Request for Market Authorization of MIRA

Retrieved on: 
Monday, May 22, 2023
Investigational device exemption, Surgeon, De novo, MBA, History, Trial of the century, Lincoln, Hospital, Capital, RAS, MD, Investment, Patient, Miniaturization, MIRA, Abdominal ultrasonography, IDE, Robotics, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

Virtual Incision Corporation is a medical device company developing the world's first miniaturized robotic-assisted surgery system, MIRA.

Key Points: 
  • Virtual Incision Corporation is a medical device company developing the world's first miniaturized robotic-assisted surgery system, MIRA.
  • Virtual Incision Corporation is a medical device company developing the world's first miniaturized robotic-assisted surgery (RAS) system, MIRA.
  • "If we are successful with our submission, the FDA De Novo pathway will establish MIRA in a brand-new medical device category of miniaturized RAS.
  • When granted market authorization, Virtual Incision will work to deploy a limited market release of MIRA in pursuit of expanding access to RAS, either as a complementary or standalone option.

Abbott Unveils Late-Breaking Data Showing the World's First Dual-Chamber Leadless Pacemaker Study Met All Three Primary Endpoints

Retrieved on: 
Saturday, May 20, 2023
Heart, Communication, Posture, HRS, Physician, The New England Journal of Medicine, Skin, Medicine, Facial muscles, Investigational device exemption, Heart Rhythm Society, Engineering, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Safety, Medical device

The data further suggests that AVEIR DR could offer new benefits for people with slower-than-normal heart rhythms.

Key Points: 
  • The data further suggests that AVEIR DR could offer new benefits for people with slower-than-normal heart rhythms.
  • The data has been provided to the U.S. Food and Drug Administration (FDA) as part of Abbott's submission for approval of the AVEIR DR device.
  • People who experience a slower-than-normal heart rate have traditionally received a pacemaker, which is a small battery-powered device implanted underneath the skin in the chest.
  • Unlike traditional pacemakers, leadless pacemakers are implanted directly into the heart through a minimally invasive, catheter-based procedure.