MedTech Spectrum

Article Name North America

Japanese medtech startup Medmain to expand to US

The startup develops and provides PidPort, an AI-powered cloud system that supports digital pathology

25th September, 2023

Bio-Gate AG signs LOI with North American medical device manufacturer for trauma implants

Bio-Gate AG (ISIN DE000BGAG981), a leading provider of innovative technologies and individual solutions for health and hygiene, has concluded a preliminary agreement (LOI, Letter-of-Intent) with a North American medical device manufacturer focusing on the trauma sector. The medical device manufacturer intends to use Bio-Gate's "HyProtectTM " coating process for its own implants in human medicine following the FDA approval process.

22nd August, 2023

4WEB Medical Launches Full Commercial Release of Cervical Spine Plating Solution

Company Adds Key Products to its Comprehensive Cervical Spine Portfolio

16th August, 2023

CareBand Obtains US Patent for IoT Wearable System Safeguarding Vulnerable Individual

CareBand, a pioneer in low-powered location-based health and safety wearable solutions, celebrates the granting of US Patent No 11,714,197. This milestone further strengthens CareBand's position as a leading innovator in the rapidly growing LPWAN market.

16th August, 2023

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