Article Name North America

Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems

10th August, 2023


Covenant High Plains Performs First Robotic Pelvic Organ Prolapse Surgery

First independent ambulatory surgery center in the region to perform advanced minimally invasive urological procedure using the Da Vinci X robot

10th August, 2023


Medcrypt Unveils FDA Cybersecurity Readiness Services for Med Device Firms

With Medcrypt's FDA Cybersecurity Readiness Services, MDMs can confidently navigate mandatory eSTAR for 510(k) submissions and the FDA's upcoming Cybersecurity Refuse To Accept Policy for other submission types, benefiting from a mock submission process with expert feedback and review.

10th August, 2023


Atlanta's First BioMech Clinical Motion Lab Utilizes AI-driven Motion Science for Trauma Recovery at Clinic and Home

BioMech, Atlanta's Independent Neurodiagnostic Clinic join forces to help patients and health care providers quantitatively measure and monitor function

03rd August, 2023


RIVANNA Secures $30.5M from BARDA to Advance Accuro XV Musculoskeletal Imaging

Accuro XV integrates ultrasound-based bone and 3D soft-tissue imaging technology with AI-enabled software.

28th July, 2023


Beckman Coulter's DxC 500 AU Chemistry Analyzer Receives FDA Clearance

Beckman Coulter Diagnostics, a clinical diagnostics leader, received FDA clearance for its new DxC 500 AU Chemistry Analyzer, an automated chemistry analyzer, expanding the company's clinical chemistry offering and demonstrating ongoing commitment to product innovation in the in vitro diagnostic industry. Designed for small-to-medium-sized laboratories, the DxC 500 AU Chemistry Analyzer is one of several recent Beckman Coulter solutions designed to optimize laboratory workflows and support critical clinical decisions.

26th July, 2023


Alma Veil™ Launched in the U.S. Market by Sisram Medical's Alma

Alma, a global leader in the energy-based medical and aesthetic solutions industry, proudly announces the commercial availability of Alma Veil™. This advanced, dual-wavelength vascular laser workstation establishes a new standard in excellence by optimizing efficiency with remarkable efficacy across a comprehensive range of vascular and dermatological conditions.

26th July, 2023


BD Receives FDA 510(k) Clearance for Updated BD Alaris™ Infusion System

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, announced that the updated BD Alaris™ Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), which enables both remediation and a return to full commercial operations for the most comprehensive infusion system available in the United States.

24th July, 2023


UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Initial clinical study results will inform pivotal clinical trial in U.S. and Europe

21st July, 2023


Verantos' AI Advancement in Neurology Bolstered by Groundbreaking Migraine Real-World Evidence

Technology enables inference of subjective outcomes from routinely collected data

20th July, 2023


Hackensack Meridian JFK University Medical Center Performs First Robotic Surgery with Heated Chemotherapy for Malignant Thymoma

Surgeons in the Division of Thoracic Surgery at JFK University Medical Center first in the State of New Jersey to perform this surgery

19th July, 2023


Quest Diagnostics with Australian firm Envision Sciences launches novel prostate cancer test in US

According to the American Cancer Society, about 1 out of every 8 men will be diagnosed with prostate cancer during his lifetime

19th July, 2023


Optina's REPHRASE Study Validates Innovative Alzheimer's Test

Optina Diagnostics' pioneering pivotal REPHRASE study, currently underway, is poised to revolutionize the diagnosis and management of Alzheimer's Disease (AD). This landmark study is focused on validating the novel awAIr™-Cerebral Amyloid Status (CAS) test, an innovative tool intended to provide physicians with definitive information about Alzheimer's pathology, enabling improved management of cognitive impairments.

18th July, 2023


Kidney Patients Expand Worldwide Impact on Medical Innovations

Patient-Led Global Summit on Science, Policy, and Care Choice Drives Optimism

17th July, 2023


ExThera Medical Receives FDA Approval for OncoBindTM Procedure in Pancreatic Cancer Patients

OncoBindTM IDE Approved to Study Metastatic Cancer

14th July, 2023


Strive Health and Prominence Health Plan Partner to Improve Care for Kidney Patients

hrough this partnership, Strive Health, Prominence Health Plan and Sierra Nevada Specialty Care will bring high-quality care to patients with kidney disease across Nevada

14th July, 2023


VICHY Laboratoires Partners with Embr Labs to Bring Clinically Proven Care to Women in Menopause

Leading Global Skincare Brand Reinforces Commitment to Menopausal Skincare by Joining Forces with Innovative Wellness Technology to Empower Women During the Menopause Transition

13th July, 2023


AlloSource's ACEConnex™ Fascia Receives FDA Clearance for Hip Labral Reconstruction

First pre-sutured fascia allograft designed for hip arthroscopists to help increase surgeon efficiency and reduce operating room time

12th July, 2023


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