All articles by Manish Kumar

Manish Kumar

Elixir Medical secures FDA breakthrough status for DynamX bioadaptor

The device is intended to enhance coronary luminal diameter, restore hemodynamic modulation, and lower plaque progression in individuals with symptomatic ischemic heart disease

Akili’s EndeavorOTC digital treatment gets FDA clearance for ADHD

The approval was based on a clinical trial in which 83% of participants reported improved focus and 72.5% of enrolled patients demonstrated some enhancement in quality of life

ColdVentures unveils first-of-its-kind, Class 1 FDA medical device ColdVest to prevent heat-related deaths

Portable Vest Protects Military Personnel, Outdoor Workers, Athletes, Students and More Without Requiring Electricity or Refrigeration

Haemonetics launches limited market release for new VASCADE MVP XL vascular closure device

The VASCADE MVP XL system expands Haemonetics’ VASCADE portfolio of vascular closure systems featuring an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis

AEYE Health, Optomed to introduce Aurora AEYE diabetic retinopathy screening solution

Aurora AEYE is a portable, AI-powered, fully autonomous solution made from combining AEYE-DS technology with the Optomed Aurora portable handheld device

Elutia secures FDA clearance for EluPro antibiotic-eluting bioenvelope

EluPro helps form a healthy, vascularised pocket derived from the patient’s tissue to provide protection from post-operative complications arising from devices such as implantable cardiac pacemakers and defibrillators

OMNIVISION announces smallest Camera Module for 3D Intraoral Dental Scanners

New OCH2B30 CameraCubeChip module is a compact wafer-level module with superior video quality

BrainsWay expands global imprint with exclusive multi-year distribution agreement in Canada

The agreement includes minimum quantity orders which increase successively over several years, starting with 11 Deep TMS systems to be ordered in 2024

Proteomics International taps Growth Medics to expand in Europe

Growth Medics will assist Proteomics International to identify and select EU alliance partners for the latter’s PromarkerD predictive test for diabetic kidney disease

Co-Diagnostics files FDA 510(k) application for Co-Dx PCR Pro platform

The Co-Dx PCR platform aims to address the gap in access to infectious disease diagnostics by enabling widespread decentralisation of polymerase chain reaction testing