IDE

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

Retrieved on: 
Friday, March 1, 2024
Boston Scientific, Diabetes, Obstruction, DCB, Interventional cardiology, Physician, FDA, ISR, Quality of life, Food, Restenosis, Find, BSX, IDE, Plaque, Radiation, Risk, Food and Drug Administration, Patient, TLF, Coronary artery disease, Pharmaceutical industry

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
Cloud, SSO, Running, Saas, DataOps, IDE, Entrepreneurship, Dataproducts, Risk, Software as a service, DevOps, Fear, Automation, Single sign-on, Complexity, Snowflake, AWS, Environment

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
Degenerative disc disease, Freedom, Spine, C3, MD, Surgeon, IDE, Decompression, Patient, Federal, C7, Birth control

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
MIRA, MD, FDA, Thought, IDE, MBA, General surgery, Gynaecology, Capital, Medicine, Hand, Trial of the century, Incision, Robotics, Medical device

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
JIS, SAN, Collection, Division, Total, PROM, Roentgen stereophotogrammetry, MD, Physician, FDA, Effectiveness, Orthopedic surgery, Quality of life, Shore Medical Center, Dislocation, HRS, IDE, Eye, Entrepreneurship, RSA, Agency, Risk, Narration, Safety, Arthralgia, THA, Patient, HIT, Hip, Investigational device exemption, AAOS, Reverse, Roentgen, Motion, American Academy, Medical device

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, Incidence, Degenerative disease, Stair climbing, Orthopedic surgery, FDA, Obesity, Pain, Mutation, Swelling, Exercise, IDE, Visual analogue scale, Conference, Prevalence, Safety, Elective surgery, Canaccord Genuity, Patient, Knee, Cadaver, Investigational device exemption, AAOS, American Academy, Pharmaceutical industry

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.

New Late Breaking Preliminary Data Demonstrate Balt’s Squid™ Liquid Embolic May Improve Outcomes in Patients with Chronic Subdural Hematomas

Retrieved on: 
Friday, February 9, 2024
Randomized controlled trial, Balts, Veterans' affairs, Embolization, FDA, Prevalence, STEM, Disability, Conference, University, SDH, Physician, MPH, United, MMA, IDE, Incidence, Epidural hematoma, Patient, Person, Stony Brook University Hospital, Ageing, Disease, Doctor of Philosophy, Death, Pharmaceutical industry

The preliminary data demonstrates that rates of complications thus far are low and embolizing the MMA for the treatment of Chronic Subdural Hematoma (cSDH) potentially improves the success rates of both surgical and non-surgical treatments.

Key Points: 
  • The preliminary data demonstrates that rates of complications thus far are low and embolizing the MMA for the treatment of Chronic Subdural Hematoma (cSDH) potentially improves the success rates of both surgical and non-surgical treatments.
  • Standard management included surgical drainage of the subdural hemorrhage for qualified patients and best medical management for patients who did not require surgery.
  • STEM, which completed enrollment last year, is the first prospective IDE trial investigating embolization of the MMA for the treatment of chronic Sub-Dural Hematoma (cSDH).
  • A Veterans Affairs (VA) study of cSDH found a prevalence rate of 79.4 per 100,000 persons.

New Study Reveals Cost-Effective Lumbar Facet Arthroplasty For Degenerative Spondylolisthesis And Stenosis

Retrieved on: 
Thursday, February 8, 2024
WTP, Treatment, Laminectomy, The Spine Journal, FDA, ICER, Quality of life, Stenosis, NMB, Medicare, RCT, IDE, Patient, Spine, Data, Pharmaceutical industry

NORWALK, Conn., Feb. 8, 2024 /PRNewswire-PRWeb/ -- In a significant development, Premia Spine, a leading medical device company, has unveiled the results of a groundbreaking study published in The Spine Journal, reaffirming the cost-effectiveness and superiority of their Total Posterior Spine (TOPS™) System. This study, titled "A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis," presents a comprehensive evaluation based on an updated FDA investigational device exemption (IDE) dataset. Read Full Study Here: The Spine Journal

Key Points: 
  • This study, titled " A Prospective Study of Lumbar Facet Arthroplasty in the Treatment of Degenerative Spondylolisthesis and Stenosis ," presents a comprehensive evaluation based on an updated FDA investigational device exemption (IDE) dataset.
  • Read Full Study Here: The Spine Journal
    This updated analysis solidifies the TOPS™ System as a highly cost-effective and dominant surgical option for patients with lumbar stenosis and degenerative spondylolisthesis, offering significant benefits to both healthcare systems and patients alike.
  • Conducted as a multicenter, FDA IDE, randomized control trial (RCT) with 305 enrolled subjects, the study yielded significant insights.
  • Overall, this updated analysis solidifies the TOPS™ System as a highly cost-effective and dominant surgical option for patients with lumbar stenosis and degenerative spondylolisthesis, offering significant benefits to both healthcare systems and patients alike.

MIVI Neuroscience™ Presents Primary Endpoint Results from the EvaQ Trial — at the 2024 International Stroke Conference

Retrieved on: 
Thursday, February 8, 2024
Technology, Radiology, Health Technology, Pharmaceutical, Neurology, Other Science, Research, Medical Devices, Infectious Diseases, Hospitals, Clinical Trials, Cardiology, Biotechnology, Health, Practice Management, General Health, Nanotechnology, Science, Medical Supplies, Software, FDA, Surgery, Other Health, Sich, CE marking, Cerebrovascular disease, LVO, NIHSS, Conference, Bangladesh Technical Education Board, Intracranial hemorrhage, Thrombectomy, Safety, Physician, ECASS, Reperfusion, IDE, Thrombus, Patient, Stroke, System, Death

MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.

Key Points: 
  • MIVI Neuroscience, Inc. (Eden Prairie, MN) announces the primary endpoint results of its EvaQ Trial, a prospective, multi-center, global, single arm, FDA-regulated IDE trial study to evaluate the safety and effectiveness of the MIVI Q™ Revascularization System for treating acute ischemic stroke.
  • The data were presented yesterday at the 2024 International Stroke Conference (AZ), a premier event featuring global thought leaders and dedicated to the latest in the science and treatment of cerebrovascular disease and brain health.
  • Results of the EvaQ Trial show the Q Revascularization System to be safe and effective for thrombectomy of Large Vessel Occlusion (LVO) strokes.
  • The primary safety endpoint was symptomatic intracranial hemorrhage (sICH) which was observed at a rate of 6.5%.

Silicon Labs and Arduino Partner to Democratize Matter

Retrieved on: 
Tuesday, February 6, 2024
Partnership, GitHub, DBm, Family, Silicon Labs, Internet of things, Language, Environment, RAM, Running, Ecosystem, Simplicity, Certification, Wireless, Documentation, Arduino Nano, Silicon, Privacy, SparkFun Electronics, Student, Software, IDE, GPIO, Library, Video game

AUSTIN, Texas, Feb. 6, 2024 /PRNewswire/ -- Silicon Labs (NASDAQ: SLAB), a leader in secure, intelligent wireless technology for a more connected world, today announced a new partnership in collaboration with Arduino, the global leader in open-source hardware and software, to better enable seamless development of Matter over Thread applications for Arduino's 33 million-strong developer community. Developed in collaboration with Silicon Labs, Arduino's first-ever Matter software libraries are available today on both the xG24 Explorer Kit from Silicon Labs and the xG24-based SparkFun Thing Plus Matter – MGM240P development board.

Key Points: 
  • Developed in collaboration with Silicon Labs, Arduino's first-ever Matter software libraries are available today on both the xG24 Explorer Kit from Silicon Labs and the xG24-based SparkFun Thing Plus Matter – MGM240P development board.
  • Code samples, reference designs, documentation and more are now live in the Arduino Core for Silicon Labs Devices GitHub page.
  • This new partnership between Silicon Labs and Arduino is a part of Silicon Labs' ongoing goal to make IoT development as user-friendly and expedient as possible.
  • Learn more about how Silicon Labs is looking inward and outward to make the lives of developers easier: