US Food and Drug Administration (FDA)

US Food and Drug Administration (FDA)

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2020
15 Jan

FlexDex Surgical

FlexDex Surgical, founded in 2013, is a medical technology company. Its device enables surgeons to perform minimally invasive surgical procedures.
10 Jan

Polytechnique Montréal - NanoRobotics Laboratory

The NanoRobotics Lab has developed a robotic platform that enables endovascular interventional procedures in deep and difficult to reach areas of the vasculature.
6 Jan

23andme

23andme is the first company and the unicorn, to offer autosomal DNA testing for ancestry and health-related components.
6 Jan

Spartan Bioscience

Spartan Bioscience first launched themselves into the point-of-care molecular diagnostics industry with a pharmacogenomics application for drug metabolism using their first platform, the Spartan RX, in 2010.
6 Jan

Guardant

Guardant is a liquid biopsy leader in the United States, selling liquid biopsy tests that "map" out genomic results for advanced cancer tumors, helping match individual patients with the right cancer treatment.
3 Jan

BioRad Laboratories

Bio-Rad Laboratories is a manufacturer and distributor of its own life science research and clinical diagnostics products, and has two primary segments: life science and clinical diagnostics.
2019
31 Dec

MobioSense

IDTechEx spoke with MobioSense CEO Wendell Su.
31 Dec

Aulisa

IDTechEx first met Aulisa at CES 2019.
30 Dec

Auris Health

In March 2018, Auris Health also became a threat to Intuitive Surgical when its catheter-based Monarch Platform gained FDA clearance.
30 Dec

Transenterix

A key turning point in the surgical robot space came in October 2017 when TransEnterix received FDA clearance for its Senhance Surgical Robotic System, which is used in minimally invasive gynaecologic, colorectal, hernia repair, and cholecystectomy procedures.
30 Dec

Corindus Vascular Robotics

Corindus Vascular Robotics developed the CorPath System, a FDA cleared and CE marked system for peripheral and coronary vascular interventions.
30 Dec

Intuitive Surgical

Intuitive Surgical was founded in 1995 by Frederic Moll and John Freund and is headquartered in Sunnyvale, California.
20 Dec

OR Productivity

OR Productivity designs and manufactures robotic systems that hold and manipulate a camera during laparoscopic abdominal surgical procedures. The company has developed two robotic arm systems, Freehand Vista and Freehand Panorama.
18 Dec

Curexo

Curexo operates in two very different fields: medical and trades. The medical field includes surgical robots, rehabilitation robots, robot supplies and services, and artificial joint supplies (implants). Its trades business include food, food additives and livestock products.
16 Dec

Advancments in 3D Printing Technology for Orthopaedic Care

It is no secret that technology is transforming the healthcare industry at rapid speed. The idea of 3D printing a patient's specific fracture pattern or bone pathology on command seemed like science fiction just a few years ago; however, 3D printing technology is revolutionizing orthopaedic care and is making this process a reality today.
16 Dec

FDA Rare Pediatric Disease Designation for AuriNovo

3DBio Therapeutics has announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia.
10 Dec

Reducing Risk in AI and Machine Learning-Based Medical Technology

Artificial intelligence and machine learning are increasingly transforming the healthcare sector. From spotting malignant tumours to reading CT scans and mammograms, AI/ML-based technology is faster and more accurate than traditional devices - or even the best doctors. But along with the benefits come new risks and regulatory challenges.
6 Dec

SDS Optic

SDS Optic is a medical device company based in Lublin, Poland.
6 Dec

Fluxergy

Fluxergy, a biotechnology company based in California, was exhibiting Fluxergy Analyser - a POC diagnostics device - at Medica 2019.
6 Dec

Fischer Analysen Instrumente

Fischer Analysen Instrumente - based in Leipzig, Germany - produces breath test devices for POC diagnostics.