IDE

Stonebranch Announces Record-Breaking Growth in 2023, Sets Sights on Future Innovations

Retrieved on: 
Tuesday, February 27, 2024

Stonebranch, a leading provider of service orchestration and automation solutions, announced another year of significant growth and innovation.

Key Points: 
  • Stonebranch, a leading provider of service orchestration and automation solutions, announced another year of significant growth and innovation.
  • Reflecting on the company's growth, Stonebranch CEO Giuseppe Damiani stated, "2023 was a pivotal year for Stonebranch.
  • As organizations continue to navigate the complexities of digital transformation, Stonebranch continues to be a provider and partner of choice.
  • "Innovation is at the heart of everything we do at Stonebranch,” says Stonebranch CTO Peter Baljet.

Pulmonx Announces Treatment of the First Patient with the AeriSeal® System in CONVERT II Pivotal Trial

Retrieved on: 
Monday, February 26, 2024

Successful treatment with the AeriSeal System is followed by treatment with commercially available Zephyr® Valves.

Key Points: 
  • Successful treatment with the AeriSeal System is followed by treatment with commercially available Zephyr® Valves.
  • Pulmonx received a staged IDE approval by the Food and Drug Administration (FDA) to commence the CONVERT II Pivotal Trial for the AeriSeal System in late 2023.
  • Severe COPD/emphysema patients with collateral ventilation confirmed with Pulmonx’s proprietary Chartis® Pulmonary Assessment System (Chartis) undergo the AeriSeal System treatment.
  • “We hope the CONVERT II Trial will move us closer to the goal of helping patients with collateral ventilation to also receive benefit from our Zephyr Valves.”

Virtual Incision Receives FDA Authorization for the MIRA Surgical System as the First Miniaturized Robotic-Assisted Surgery Device

Retrieved on: 
Saturday, February 24, 2024

Virtual Incision Corporation announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization of the MIRA™ Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (miniRAS) device, for use in adults undergoing colectomy procedures.

Key Points: 
  • Virtual Incision Corporation announced the U.S. Food and Drug Administration (FDA) has granted marketing authorization of the MIRA™ Surgical System (MIRA), the world’s first miniaturized robotic-assisted surgery (miniRAS) device, for use in adults undergoing colectomy procedures.
  • FDA authorization was based in part on findings from the company’s U.S. Investigational Device Exemption (IDE) clinical study.
  • The announcement was made by Virtual Incision’s president and chief executive officer, John Murphy, at the SAGES 5th Annual Next Big Thing Innovation Weekend in Houston.
  • “Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” said John Murphy.

BiVACOR® Receives $13 Million to Support Clinical Trials for the Company’s Total Artificial Heart

Retrieved on: 
Tuesday, February 20, 2024

BiVACOR® , a clinical-stage medical device company, today announced $13 million (USD) awarded from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP) to support BiVACOR’s Total Artificial Heart program and future product enhancements.

Key Points: 
  • BiVACOR® , a clinical-stage medical device company, today announced $13 million (USD) awarded from the Australian Government’s Medical Research Future Fund (MRFF) grant through the Artificial Heart Frontiers Program (AHFP) to support BiVACOR’s Total Artificial Heart program and future product enhancements.
  • View the full release here: https://www.businesswire.com/news/home/20240220429887/en/
    BiVACOR® Total Artificial Heart (TAH) in Surgeon's Hands (Photo: Business Wire)
    Led by Monash University, the AHFP is comprised of a consortium of research centers in Australia in collaboration with BiVACOR.
  • The award will support clinical work of the BiVACOR Total Artificial Heart (TAH) and begin development for the integration of wireless power sources for the device.
  • “There is a huge gap between available treatment options and the number of patients with severe heart failure.

Boston Scientific Receives FDA Approval for the AGENT™ Drug-Coated Balloon

Retrieved on: 
Friday, March 1, 2024

MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue.

Key Points: 
  • First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence
    MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in patients with coronary artery disease.
  • ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue.
  • Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9029352-boston-scientific-fda-ap...
    "With more than 100,000 patients treated globally to date in both clinical and commercial settings, we are very pleased to introduce this proven therapy as the first drug-coated coronary balloon in the U.S," said Lance Bates, president, Interventional Cardiology Therapies, Boston Scientific.
  • Boston Scientific plans to launch the technology in the U.S. in the coming months.

DataOps.live Launches Professional Edition, Delivering dbt Core Workloads with Support and Security

Retrieved on: 
Thursday, February 29, 2024

The Professional Edition is a purpose-built environment for small data teams and dbt Core developers, designed to allay the concerns associated with running production workloads on an open-source product.

Key Points: 
  • The Professional Edition is a purpose-built environment for small data teams and dbt Core developers, designed to allay the concerns associated with running production workloads on an open-source product.
  • DataOps.live Professional enables small data engineering teams to scale, automate and safeguard data applications and data products in a fully supported SaaS environment.
  • DataOps.live Professional Edition enables you to:
    Move your dbt Core projects into a fully managed, supported and enhanced environment.
  • "With the Professional Edition, dbt Core developers can now harness the full potential of a supported, secure, and robust DataOps environment with a fully managed and maintained dbt Core environment to build, lifecycle manage and deploy dbt Core workloads.

SPINEART COMPLETES ENROLLMENT IN THE BAGUERA®C IDE TRIAL FOR SINGLE-LEVEL CERVICAL DISC REPLACEMENT

Retrieved on: 
Thursday, February 29, 2024

GENEVA, Feb. 29, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc implant.

Key Points: 
  • GENEVA, Feb. 29, 2024 /PRNewswire/ -- Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc implant.
  • "We are committed to advancing spine arthroplasty worldwide and establishing BAGUERA®C as a leading motion preserving technology for US surgeons and their patients."
  • The BAGUERA®C Cervical Disc Prosthesis has been commercially available in selected European and worldwide markets since 2008 with over 60,000 implants sold.
  • The BAGUERA®C Cervical Disc Prosthesis, developed by Spineart SA (Geneva, Switzerland), is an investigational device designed to maintain or restore segmental motion and disc height in the cervical region of the spine following single- or two-level discectomy for symptomatic cervical disc disease.

Virtual Incision Receives FDA Authorization for the First Miniaturized Robotic-Assisted Surgery Device

Retrieved on: 
Tuesday, February 27, 2024

GRAND RAPIDS, Mich., Feb. 27, 2024 /PRNewswire/ -- Virtual Incision , a cultivate(MD) portfolio company , has been granted marketing authorization of the MIRA™ Surgical System (MIRA) from the FDA.

Key Points: 
  • GRAND RAPIDS, Mich., Feb. 27, 2024 /PRNewswire/ -- Virtual Incision , a cultivate(MD) portfolio company , has been granted marketing authorization of the MIRA™ Surgical System (MIRA) from the FDA.
  • This marks a significant milestone as MIRA becomes the first miniaturized robotic-assisted surgery device in the world approved for adult colectomy procedures.
  • FDA authorization was based in part on findings from the company's U.S. Investigational Device Exemption (IDE) clinical study.
  • With FDA authorization in hand, Virtual Incision is set to initiate MIRA's commercial rollout in select centers in the United States.

Reverse Hip Replacement System Unveiled at Global Orthopedic Surgery Meeting

Retrieved on: 
Thursday, February 15, 2024

SAN FRANCISCO, Feb. 15, 2024 /PRNewswire/ -- Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, today announced that its flagship product, the Reverse Hip Replacement System (Reverse HRS) was showcased at the 2024 American Academy of Orthopaedic Surgeons (AAOS) annual meeting, taking place in San Francisco, CA from February 12 -16, 2024.

Key Points: 
  • "We are extremely excited that the Reverse HRS was featured at AAOS in the OrthoDome with a video of an actual hip replacement surgery narrated by Dr. Adolph Lombardi," said George Diamantoni, Hip Innovation Technology's Co-Founder and Chief Executive Officer.
  • The presentation featured high resolution video of Dr. Lombardi conducting a hip replacement with the new Reverse HRS.
  • The Bone & Joint Open journal, recently published the article, "Radiostereometric analysis and clinical outcomes of a novel reverse total hip system at two years."
  • Hip replacement surgery, or total hip arthroplasty, is one of the most common joint replacement procedures done in the United States.

ZKR Orthopedics Receives IDE Approval for Clinical Trial

Retrieved on: 
Wednesday, February 14, 2024

SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.

Key Points: 
  • SAN FRANCISCO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ZKR Orthopedics, Inc., a clinical stage medical device company, announced that it has received Investigational Device Exemption (IDE) approval from the United States Food and Drug Administration (FDA) for a multicenter prospective clinical trial.
  • We expect the data collected by this trial will establish a strong foundation of compelling clinical evidence for the LIFT implant approval for clinical use," commented David Cash, CEO of ZKR Orthopedics.
  • The IDE approval announcement was made as part of the ZKR Orthopedics activities at the 2024 American Academy of Orthopedic Surgeons annual meeting in San Francisco.
  • In addition to reporting IDE trial approval, the Company participated in the Canaccord Genuity Musculoskeletal Conference earlier this week.