CE marking

Infinity Neuro Receives CE Mark Approval for Their First Device to Treat Stroke

Retrieved on: 
Friday, January 27, 2023
LVO, Stroke, Patient, AIS, CE marking, MDR, Ambient occlusion, III, Medical device, European, EU

LAKE FOREST, Calif., Jan. 27, 2023 Infinity Neuro announced today that its Inspira™ aspiration catheters received CE Mark approval and are now commercially available in Europe.

Key Points: 
  • LAKE FOREST, Calif., Jan. 27, 2023 Infinity Neuro announced today that its Inspira™ aspiration catheters received CE Mark approval and are now commercially available in Europe.
  • This is the first offering from Infinity Neuro which plans to launch a full range of products for the treatment of ischemic and hemorrhagic stroke throughout 2023 and beyond.
  • Additionally, this milestone represents the company's commitment and ability to attain class III medical device approvals through the new, rigorous European MDR CE certification process which in today's market, medical device companies find challenging.
  • This marks the first neurovascular device approved under the new European MDR CE certification process as an original submission.

Late-Breaking ACQFORCE FLUTTER Trial Meets Primary Endpoint for Safety and Efficacy with the First Gold-Tipped Contact Force Sensing Ablation Catheter

Retrieved on: 
Monday, February 6, 2023
Arrhythmia, CE marking, Safety, Thermal conductivity, Gold, Pulmonary vein, PMA, AFIB, Ablation, Kishan Chand Parwani, Clinical study design, Atrial flutter, IDE, Physician, Catheter ablation, Patient, Blazer, Platinum, Cardiology (journal), Superior, Cardiology, Electrophysiology, Baptist Health, Atrial fibrillation, Temperature, Medical imaging, Pharmaceutical industry

“AcQBlate’s novel gold tip ablation catheter performed extremely well during the clinical IDE atrial flutter cases.

Key Points: 
  • “AcQBlate’s novel gold tip ablation catheter performed extremely well during the clinical IDE atrial flutter cases.
  • The AcQBlate FORCE sensing ablation catheter and system, which received CE Mark in 2020, is commercially available in Europe.
  • The AcQBlate FORCE sensing ablation catheter was designed to provide consistent, effective therapeutic delivery during cardiac ablation procedures.
  • AcQForce Flutter Trial Clinical Results: Force Sensing RF Ablation with Low Flow Gold Tip Catheter for Typical Flutter.

Asensus Surgical Receives CE Mark for Expanded Machine Vision Capabilities

Retrieved on: 
Monday, January 23, 2023
ISU, Paola Lattus, CE marking, Communication, 3D, RESEARCH, Software, NYSE, Da Vinci Surgical System, MDR, Intelligence, Union, Surgeon, PARK, Digital, Regulation, Image, Medical device, EU

RESEARCH TRIANGLE PARK, N.C., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced receipt of CE Mark for an expansion of machine vision capabilities on the previously cleared Intelligent Surgical Unit™ (ISU™).

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Jan. 23, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced receipt of CE Mark for an expansion of machine vision capabilities on the previously cleared Intelligent Surgical Unit™ (ISU™).
  • With this CE Marking, the expanded ISU capabilities are now commercially available across all of the Company’s key geographies, including the European Union, Japan, and the U.S.
  • “We are thrilled to be able to offer these ground-breaking ISU capabilities to surgeons in the EU.
  • With these new ISU features, I expect that the Senhance Surgical System will be a technology leader in the field of augmented intelligence in surgical robotics."

Europe Micro-Surgical Robot Market Report 2023: Rising Popularity of Minimally Invasive Surgical Procedures Bolsters Sector - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 12, 2023
Surgery, Health, Robotics, Technology, Health Technology, Hospital, MUSA, COVID-19, CE marking, Safety, ENT, Control, Microsurgery, Neurosurgery, MMI, Growth, Patient, Center for Urban and Regional Analysis, Component, Human, Movement, Medical device, Repeatability

The "Europe Micro-Surgical Robot Market Forecast to 2028 - COVID-19 Impact and Regional Analysis - by Component, Application, and End User" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Europe Micro-Surgical Robot Market Forecast to 2028 - COVID-19 Impact and Regional Analysis - by Component, Application, and End User" report has been added to ResearchAndMarkets.com's offering.
  • The Europe micro-surgical robot market is expected to grow at a remarkable CAGR during the forecast period.
  • Based on end user, the Europe micro-surgical robot market is categorized into hospitals and clinics, ambulatory surgical centers, research institutes, and others.
  • Based on country, the Europe micro-surgical robot market is segmented into Germany, UK, France, Italy, Spain, and Rest of Europe.

LinusBio Raises $16 Million to Scale Growth and Deliver Tangible Outcomes

Retrieved on: 
Thursday, January 12, 2023
Mental Health, Managed Care, Medical Devices, General Health, Hospitals, Neurology, Science, Genetics, Clinical Trials, FDA, Biotechnology, Health, Health Technology, Other Science, Research, Biometrics, Oncology, Partner (business rank), Psychosis, Farmer, Union, Entrepreneurship, Francisco Partners, Cancer, Physiology, Factor X, Autism, White House, Degenerative disease, ALS, General partnership, CE marking, Amyotrophic lateral sclerosis, Hair, PECASE, Environment, Biomarker, FDA, Organization, Diagnosis, Inflammatory bowel disease, Genomics, Investment, DRS, Science, White, Gastroenterology, Kidney, Farmers Business Network, Schizophrenia, Medical imaging, Medicine, Salesforce

It is the first technology platform that maps the molecular dynamics of human physiology in a time-dependent manner.

Key Points: 
  • It is the first technology platform that maps the molecular dynamics of human physiology in a time-dependent manner.
  • “Our mission is simple: to deliver better outcomes for people and families affected by complex health conditions,” said Manish Arora, PhD., Co-Founder and CEO of LinusBio.
  • “LinusBio has the opportunity to fundamentally transform the healthcare industry.”
    Arora, the CEO of LinusBio, is an environmental epidemiologist and exposure biologist.
  • The funding will be used to grow the LinusBio team, deliver more positive outcomes across more health conditions, and develop a world-class platform that will serve as a central hub for diagnostics and treatment.

Asensus Surgical Provides Preliminary 2022 Year-End Corporate Update

Retrieved on: 
Monday, January 9, 2023
ISU, European Medical Writers Association, PARK, MDR, PMDA, Image, CE marking, Digital, Leonardo da Vinci, Operation Time, GYN, Anatomy, Surgeon, NYSE, 3D, Kitakyushu, U.S. FDA, Growth, Acceleration, Patient, Urology, Sale, General surgery, Freedom, RESEARCH, Gynaecology, TRUST, CIS, Investment, Dentistry, Medical device, Security (finance), Video game, Medicine

RESEARCH TRIANGLE PARK, N.C., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today provided a preliminary 2022 year-end corporate update.

Key Points: 
  • RESEARCH TRIANGLE PARK, N.C., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today provided a preliminary 2022 year-end corporate update.
  • During the fourth quarter of 2022, the Company initiated five new Senhance Surgical System placements, two in Germany, two in Japan, and one in the CIS region.
  • In 2022, the Company initiated nine new Senhance Surgical System placements: four in Germany, three in Japan, and two in the CIS region.
  • For the quarter ended December 31, 2022, the Company estimates preliminary unaudited revenue of approximately $2.2 - $2.8 million.

Activ Surgical Announces Completion of First AI-Enabled Case Using Its ActivSight™ Intelligent Light

Retrieved on: 
Monday, January 9, 2023
Software, Hardware, Surgery, Health, Artificial Intelligence, Hospitals, Health Technology, Technology, Union, OR, Division, CE marking, Trial of the century, Safety, Surgeon, MD, FDA, Ohio State University Wexner Medical Center, AI, Artificial intelligence, Mode, Ohio State University, Intelligence, Rectum, Cancer, Intelligent lighting, Surgery, Perfusion, Health, Medical device, Medical imaging

Activ Surgical , a digital surgery pioneer, today announced that it has completed its first artificial intelligence (AI)-enabled case using its product, ActivSight™ Intelligent Light (ActiveSight), which aims to provide enhanced visualization and real-time, on-demand surgical insights in the operating room.

Key Points: 
  • Activ Surgical , a digital surgery pioneer, today announced that it has completed its first artificial intelligence (AI)-enabled case using its product, ActivSight™ Intelligent Light (ActiveSight), which aims to provide enhanced visualization and real-time, on-demand surgical insights in the operating room.
  • ActivSight is an easy-to-adapt module that seamlessly attaches to today’s laparoscopic and robotic systems and integrates with standard monitors.
  • Activ Surgical is currently conducting a clinical study with Ohio State Wexner Medical Center to evaluate the utility and usability of ActivSight.
  • “At Activ Surgical, we are driven to learn from every procedure using enhanced, real-time visualization capabilities combined with augmented reality, artificial intelligence and machine learning technology so that we can deliver intelligent information to doctors around the world to reduce surgical complication rates,” said Manisha Shah-Bugaj, Chief Executive Officer at Activ Surgical.

Novocure Announces Preliminary Full Year and Fourth Quarter 2022 Net Revenues and Provides Company Update

Retrieved on: 
Monday, January 9, 2023
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, Large-cell lung carcinoma, EST, Health Canada, CE marking, Prescription, Neoplasm, Partnership, Regulation, Survival, Webcast, Patient, Cancer, Glioblastoma, ICI, GBM, Regulation Fair Disclosure, Disclosure, Investment, Docetaxel, Pharmaceutical industry, Fine chemical, Medical device

Novocure (NASDAQ: NVCR) today reported preliminary unaudited financial results and operational updates for the quarter and full year ended December 31, 2022.

Key Points: 
  • Novocure (NASDAQ: NVCR) today reported preliminary unaudited financial results and operational updates for the quarter and full year ended December 31, 2022.
  • Total preliminary net revenues for the fourth quarter 2022 were $128.4 million.
  • The United States, EMEA, and Japan contributed $98.6 million, $17.0 million, and $7.9 million in quarterly net revenues, respectively.
  • Novocure will host a conference call and webcast to discuss fourth quarter and full year 2022 financial results at 8:00 a.m. EST on Thursday, February 23, 2023.

MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval

Retrieved on: 
Wednesday, January 11, 2023
DEB, BTK, Peripheral artery disease, ISR, Cardiology, DES, IDE, Passiflora foetida, Risk, Aortoiliac occlusive disease, Research, Coronary artery disease, Patient, CE marking, Safety, SFA, PTCA, Georgetown University, Diabetes, Pharmaceutical industry

Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.

Key Points: 
  • Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.
  • This will complement the substantial experience that the company has already gained with the SELUTION DeNOVO trial in Europe (ClinicalTrials.gov Identifier: NCT04859985).
  • The study is powered to demonstrate superiority of SELUTION SLR drug-eluting balloon (DEB) over DES in coronary de novo artery disease.
  • "Treatment of de novo coronary arteries with drug-eluting balloons is a breakthrough in revascularization of coronary artery disease.

MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval

Retrieved on: 
Tuesday, January 10, 2023
DEB, BTK, Peripheral artery disease, ISR, Cardiology, DES, IDE, Passiflora foetida, Risk, Aortoiliac occlusive disease, Research, Coronary artery disease, Patient, CE marking, Safety, SFA, PTCA, Georgetown University, Diabetes, Pharmaceutical industry

Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.

Key Points: 
  • Enrollment of the SELUTION SLR coronary de novo study will begin in the US within the next few months.
  • This will complement the substantial experience that the company has already gained with the SELUTION DeNOVO trial in Europe (ClinicalTrials.gov Identifier: NCT04859985).
  • The study is powered to demonstrate superiority of SELUTION SLR drug-eluting balloon (DEB) over DES in coronary de novo artery disease.
  • "Treatment of de novo coronary arteries with drug-eluting balloons is a breakthrough in revascularization of coronary artery disease.