CE marking

Asensus Shares First Quarter Results and Future Plans

Retrieved on: 
Thursday, June 1, 2023
Communication, Surgeon, CE marking, OR, Research, LUNA, PCG, Patient, Investment, KARL, ISU, FDA, GI, NYSE, Medtech, Safety, Dentistry, Video game, Pharmaceutical industry

First quarter revenue was $1 million with cash, cash equivalents, short- and long-term investments, excluding restricted cash, of approximately $57.4 million at the close of the quarter.

Key Points: 
  • First quarter revenue was $1 million with cash, cash equivalents, short- and long-term investments, excluding restricted cash, of approximately $57.4 million at the close of the quarter.
  • Asensus also surpassed 10,000 procedures on its Senhance(R) Surgical System, including a new program launched in Japan - one of the company's fastest-growing regions.
  • - Asensus received CE Mark approval for expanded machine vision capabilities on the ISU, which continues to notch praise throughout the industry.
  • "These are exciting times at Asensus," said Asensus President and CEO Anthony Fernando.

Stereotaxis Reports 2023 Second Quarter Financial Results

Retrieved on: 
Thursday, August 10, 2023
Operating cost, International, Abbott, CE marking, Magic, Documentation, Average cost, Ecosystem, Robotics, NYSE, Video game, Bank, Stereotaxis

ST. LOUIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • ST. LOUIS, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today reported financial results for the second quarter ended June 30, 2023.
  • System revenue for the quarter was $3.3 million and recurring revenue was $4.6 million, compared to $0.6 million and $5.6 million in the prior year second quarter, respectively.
  • Gross margin for the second quarter of 2023 was 53% of revenue.
  • Excluding non-cash stock compensation expense, adjusted operating expenses in the current quarter were $6.9 million compared to $7.2 million for adjusted operating expenses in the prior year second quarter.

Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

Retrieved on: 
Tuesday, August 8, 2023
Heart, Freedom, Pulmonary vein stenosis, Boston Scientific, BSX, Anatomy, CE marking, Medicines and Healthcare products Regulatory Agency, Food and Drug Administration, FACC, Clinical trial, Cryoablation, Cryotherapy, Banner University Medical Center Tucson, Heart Rhythm, Patient, Freezing, Physician, PMDA, AF, FDA, NYSE, Food, Safety, Medical imaging, Medical device, FHRS, MD, Electrophysiology

MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System. The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF), features the POLARx FIT Cryoablation Balloon Catheter, a device with the unique capability of enabling two balloon sizes – 28 and 31mm – in one catheter.

Key Points: 
  • First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems
    MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System.
  • "The U.S. approval of the POLARx Cryoablation System, which has been used in more than 25,000 patients worldwide to date, marks an exciting advancement for the treatment of AF and a new era of cryoablation capabilities," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific.
  • The POLARx Cryoablation System received CE Mark in February of 2020 and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval in October of 2021.
  • The POLARx FIT catheter received approval in Europe, Japan, Canada and other Asia Pacific markets in 2023.

EQS-News: EASEE® receives a “Shark Tank” innovation award from the Epilepsy Foundation

Retrieved on: 
Thursday, July 20, 2023
Epilepsy, Seizure, SME, Epilepsy Foundation, European Innovation Council, CE marking, Innovation, Brain, Scalp, Trial of the century, Electrode, Patient, EEG, Heidelberg, Shark Tank, EIC, Caregiver, FDA, News, Disease, Security (finance), Medical device, Pharmaceutical industry

According to Prof. Jaqueline French, awarded for her lifetime achievement and Chief Medical and Innovation Officer at the Epilepsy Foundation: “The aim of the Epilepsy Foundation's Shark Tank jury is to find innovations that have the potential to reduce the burden on epilepsy patients.

Key Points: 
  • According to Prof. Jaqueline French, awarded for her lifetime achievement and Chief Medical and Innovation Officer at the Epilepsy Foundation: “The aim of the Epilepsy Foundation's Shark Tank jury is to find innovations that have the potential to reduce the burden on epilepsy patients.
  • The purpose of the award is to recognize the idea that has the potential to relieve the most epilepsy patients of their severe disease burden.
  • I personally advocate for this disease to lose its stigma”, commented Elizabeth Corbett, who is a board member of the Epilepsy Foundation.
  • The Epilepsy Foundation has been established for over 50 years and is committed to making epilepsy more visible and to supporting and networking those affected.

Integrum Marks 25 Years of Innovation and Improving Quality of Life for Individuals With Amputations

Retrieved on: 
Wednesday, July 19, 2023
Maintenance, University, Dental implant, CE marking, University of California, San Francisco, Osseointegration, Research, Brain, Sympathetic nervous system, Electrode, Professor, Hospital, Prosthesis, Patient, Restitutio ad integrum, FDA, NIH, Amputation, Medical device

Since then, Integrum has helped improve the lives of hundreds of people by allowing them to have a more active lifestyle.

Key Points: 
  • Since then, Integrum has helped improve the lives of hundreds of people by allowing them to have a more active lifestyle.
  • Initially, it was used for dental implants (and dental implants are still a major indication), but it was later adapted for prosthetic limbs.
  • In 1998, Per-Ingvar's son Dr Rickard Brånemark founded Integrum, specializing in artificial limb technology attached using osseointegration techniques.
  • This is much more than a business opportunity – this is, by far, the biggest-ever change in amputee care!,” Brånemark says.

Median Technologies Announces Onboarding of All Academic Sites Involved in the Pivotal Validation Plan for iBiopsy® LCS CADe/CADx SaMD

Retrieved on: 
Monday, July 17, 2023
Health Technology, Other Health, Technology, Radiology, Oncology, Biometrics, Medical Devices, Hospitals, Clinical Trials, Science, Biotechnology, Software, Other Science, Health, Research, CE marking, Medical device, CT, MT, CMS, University, Brag, Centers for Medicare & Medicaid Services, Intervention, LCS, Journal of Thoracic Oncology, Cancer, Lung cancer, University of Pennsylvania, Perelman School of Medicine at the University of Pennsylvania, Lung, Pulmonology, MD Anderson Cancer Center, Medicare, MD, Lalit Vachani, Patient, Clinical research, MRMC, University of Pennsylvania Health System, Diagnosis, Hospital of the University of Pennsylvania, AI, Mortality, Hospital, FDA, Respiratory Medicine, Disease, Pharmaceutical industry, Medical imaging

For the purposes of its pivotal validation plan, Median Technologies has signed clinical research agreements with world-class academic healthcare institutions, which are leading healthcare centers for the management of lung cancer patients.

Key Points: 
  • For the purposes of its pivotal validation plan, Median Technologies has signed clinical research agreements with world-class academic healthcare institutions, which are leading healthcare centers for the management of lung cancer patients.
  • Median’s pivotal validation plan is composed of a pivotal standalone performance study (MT-LCS-002) and an international Multi-Reader Multi-Case (MRMC) pivotal clinical trial (MT-LCS-004).
  • Data quality is compulsory for the proper conduct of our pivotal validation plan” said Fredrik Brag, CEO and Founder of Median Technologies.
  • Now that we have onboarded all the sites, we are on track for the launch of our iBiopsy® LCS CADe/CADx SaMD pivotal validation plan.

Lunit Makes Full-Fledged Entry into the Middle East with Participation in 'Saudi Vision 2030' Healthcare Transformation Project

Retrieved on: 
Wednesday, July 5, 2023
IBM, Partnership, AACR, Therapy, American Journal of Clinical Oncology, CE marking, Cancer, Microsoft, Multimedia, Biomarker, ASCO, Hospital, Journal, Patient, JAMA Network Open, Tuberculosis, SVH, AI, Gulf Cooperation Council, FDA, Medical device, Kingdom

The partnership seeks to contribute to driving healthcare transformation across Saudi Arabia, aligning with the Kingdom's 'Saudi Vision 2030' strategy.

Key Points: 
  • The partnership seeks to contribute to driving healthcare transformation across Saudi Arabia, aligning with the Kingdom's 'Saudi Vision 2030' strategy.
  • Under the project, Lunit has successfully delivered Lunit INSIGHT CXR, its AI solution for chest x-ray image analysis, and Lunit INSIGHT MMG, an AI solution for mammography analysis, to Seha Virtual Hospital for validation and integration purposes.
  • Established in 2022, Seha Virtual Hospital is a cornerstone of the Kingdom's healthcare innovation, which is the key initiative of the 'Saudi Vision 2030'.
  • "We are delighted to partner with Seha Virtual Hospital and contribute to the transformation of cancer diagnosis in Saudi Arabia," said Brandon Suh, CEO of Lunit.

New Data at AHS Annual Meeting Demonstrate Substantial Results for Patients Using Neurolief's Digital Therapeutics Technology to Treat Migraine

Retrieved on: 
Tuesday, June 20, 2023
Heart, Migraine, Headache (journal), CE marking, Tel Aviv University, Head, Virtual Private LAN Service, Patient, Ramot at Tel Aviv University, FDA, Headache, Regulation of tobacco by the U.S. Food and Drug Administration, Neurology, Food, Pharmaceutical industry, Management, Copper, Dietary supplement

The real-world, open label analysis presents clinically meaningful data on both the acute treatment and prevention of migraine.

Key Points: 
  • The real-world, open label analysis presents clinically meaningful data on both the acute treatment and prevention of migraine.
  • Relivion MG is a novel wearable digital therapeutic neurostimulation system, intended to treat migraine and reduce the need for drug therapies.
  • "At the heart of our mission lies a deep dedication to our patients," said Scott Drees, Neurolief's CEO.
  • "The remarkable results achieved in this subset of more difficult to treat patient population underscore the immense potential of Relivion's innovative technology in helping millions of people living with migraine."

Stereotaxis to Initiate First-in-Human Trial to Support CE Mark Application of MAGiC Catheter

Retrieved on: 
Thursday, June 15, 2023
CE marking, Notified body, NYSE, Magic, Patient, Regulation, Electrophysiology, Medical device, Stereotaxis

ST. LOUIS, June 15, 2023 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it intends to initiate a first-in-human trial to support the CE Mark submission for its MAGiC™ catheter.

Key Points: 
  • ST. LOUIS, June 15, 2023 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it intends to initiate a first-in-human trial to support the CE Mark submission for its MAGiC™ catheter.
  • Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform minimally invasive cardiac ablation procedures.
  • The catheter’s CE Mark submission was made in July 2022 and included substantial in vivo preclinical, lab and bench data.
  • Stereotaxis intends to complete a first-in-human study to support the MAGiC submission before the end of this year.

Thorne HealthTech's At-Home Blood Sampling Device - NanoDrop - Earns CE Mark Certification in the European Union

Retrieved on: 
Thursday, June 15, 2023
European Union Observatory for Nanomaterials, Nano, CE marking, Certification, Drawbridge, Collection, Engineering, European, Health, News, Safety, Medical device

NanoDrop expands Thorne's line of innovative health-care solutions, bringing virtually painless blood collection to decentralized clinical trials and at-home diagnostic testing.

Key Points: 
  • NanoDrop expands Thorne's line of innovative health-care solutions, bringing virtually painless blood collection to decentralized clinical trials and at-home diagnostic testing.
  • The clinical-grade device uses Thorne's novel dual nano lancet technology to obtain capillary whole-blood samples.
  • Although this technology is already integrated into Thorne's OneDraw blood collection system, NanoDrop's CE mark certification makes way for new testing applications by allowing individuals to use the device in their home.
  • We expect NanoDrop to kick off OneDraw's expansion into a full suite of products and solutions that leverage our unrivaled science and engineering."