Tag: Medical Devices

ANSM to Launch Pilot on Clinical Investigations under the EU MDR

France's National Agency for the Safety of Medicines and Health Products (ANSM) will launch a pilot this fall on clinical investigations under the EU medical device regulation (MDR). ANSM notes tha...

Medical Device Coordination Group Published Guidance Documents on MDR and IVDR

On 1 July 2019, the Medical Device Coordination Group (MDCG) published two guidance documents on the Medical Device Regulation (MDR) and the In-Vitro Diagnostics Regulation (IVDR). The fo...

FDA Approved Allergan’s CoolTone Device

Allergan announced CoolTone device received FDA clearance for improvement of abdominal tone, strengthening of the abdominal muscles, and development for firmer abdomen. CoolTone is also indicated for ...

GC Pharma Established Cell Therapy Development Company

GC Pharma and affiliate GC LabCell said Thursday they have jointly established a cell therapy development company called Artiva Biotherapeutics. Artiva Biotherapeutics was launched in March in San ...

First Device for Reduction of Functional Abdominal Pain in Patients 11-18 years Permitted by FDA

The U.S. Food and Drug Administration permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome ...

FDA Approved Device that Increase Access to More Lungs for Transplant

The U.S. Food and Drug Administration today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation s...

FDA Grants Permission to Market First Medical Device to Treat ADHD

The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch e...

Needle-free Injectable Drug Delivery Devices Dominate

Needle-free injectable drug delivery devices are dominating the injectable drug delivery market, with the prefilled needle-free injector segment expected to take the lead due to its ease of applicatio...

The medical devices market to keep up rapid growth by 2022

The global medical devices market is expected to post a CAGR of over 5% during the period 2018-2022, according to the latest market research report by Technavio, a market research company.

FAS Russia suggests to optimize the medical equipment market

medical devices
On 26 November 2018, the working group on Competition and Regulation of OECD Competition Committee held a Round Table on “Developing State-Financed Healthcare Market”.

MedX Health starts to develop an Artificial Intelligence Engine

MedX Health is initiating the development of an Artificial Intelligence Engine with leading dermatologists and its technology partner, Blanc Labs.

Skolkovo resident Brain Beat receives the prize at Asian Entrepreneurship Award

Brain Beat, a resident company of the Skolkovo Foundation’s biomed cluster that has developed a non-invasive glucometer, won second prize at the 7th Asian Entrepreneurship Award in Japan.

Israeli alpha-radiation cancer therapy developer starts clinical trials in Italy

Alpha Tau Medical has announced the initiation of two new clinical trials evaluating the efficacy of the Alpha DaRT) with two leading medical centers in Rome (Italy).

Novo Nordisk strikes a deal with Flex Digital Health

novo nordisk
Novo Nordisk has struck a deal with Flex Digital Health, part of the IoT logistics company Flex, formerly known as Flextronics.

Canfield Scientific to acquire VISIOMED AG

Canfield Scientific announced the acquisition of German company VISIOMED AG - the leading designer and manufacturer of dermoscopy systems.

Sechenov University to host the 5th European Congress on eCardiology and eHealth

On October 29-30, 2018 Sechenov University will hold the 5th European Congress on eCardiology and eHealth: "Connecting clinicians and technology to implement eHealth in daily practice".