Medical Devices News and Research

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Blue-light scope improves detection of bladder cancer

From day one, Robert McMichael has been determined to live the best life he can. Born with muscular dystrophy, he refused to let his physical challenges block his path to achievement and completed medical school and a demanding residency in neurology.

9 Aug 2018

FDA flags risks linked to improper use of ROM tests

The U.S. Food and Drug Administration today alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman's water has broken (also known as a rupture of the membranes containing amniotic fluid).

9 Aug 2018

Availability of Elvie Trainer could help reduce NHS annual spend on urinary incontinence

NHS Supply Chain has emphasized the importance of conservative management for stress urinary incontinence, by making available an at-home biofeedback device for pelvic floor muscle training.

7 Aug 2018

New review explores key issues in the booming medical device industry

Wearable devices are increasingly bought to track and measure health and sports performance: from the number of steps walked each day to a person's metabolic efficiency, from the quality of brain function to the quantity of oxygen inhaled while asleep.

3 Aug 2018

BrainScope receives second consecutive nomination for 2018 Prix Galien USA Awards

BrainScope today announced its second consecutive nomination for the 2018 Annual Prix Galien USA Awards for "Best Medical Technology" product.

2 Aug 2018

“Vaginal rejuvenation” procedures and devices unsafe says FDA

According to a warning from the United States Food and Drugs Administration (FDA), devices that are being sold for “vaginal rejuvenation” in women who are suffering from urinary incontinence or menopausal and sexual symptoms, can cause serious harm.

31 Jul 2018

DePuy Synthes introduces new CONCORDE LIFT Implant to treat patients with degenerative disc disease

Johnson & Johnson Medical Devices Companies today announced that DePuy Synthes is launching the CONCORDE LIFT Expandable Interbody Device in the U.S.

From DePuy Synthes 27 Jul 2018

CERENOVUS announces launch of novel stent retriever for treating stroke patients

CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced the first patients have been treated with its new EMBOTRAP II Revascularization Device since it became commercially available in the U.S. EMBOTRAP II is a next-generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke.

26 Jul 2018

Co-Diagnostics obtains CE mark approval for Logix Smart MTB Test

Co-Diagnostics, Inc., a molecular diagnostics company with a unique, proprietary platform for the development of molecular diagnostic tests, announced today that its Logix Smart™ MTB Test has obtained CE mark approval, the principle regulatory clearance allowing the test to be sold as an in vitro diagnostic for the diagnosis of tuberculosis in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval.

25 Jul 2018

Profiles for sale: How bits of captured data paint a valuable picture of your health

Here's a fun activity. Let's look at my credit card statement from last month. Among other things, I paid for a pair of athletic leggings, four movie tickets, and two beers and a plate of nachos at a nearby restaurant.

24 Jul 2018

Roche receives Breakthrough Device Designation from FDA for new Alzheimer's disease assays

Roche announced today, that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF.

From Roche Sequencing and Life Science 24 Jul 2018

AVITA Medical expands management team to support launch of RECELL device to treat burns

AVITA Medical today announced that it expanded its management team in the commercial, legal and medical affairs functions to support the planned U.S. launch of the RECELL® Autologous Cell Harvesting Device in the treatment of burns

20 Jul 2018

Vallum receives FDA clearance to market PEEK spinal interbody fusion device

Vallum Corporation, a medical device company, today announced that it has received clearance from the U.S. Food and Drug Administration to market a polyetheretherketone spinal interbody fusion device with a PEEKplus nanotextured surface created by Vallum's proprietary and patented Accelerated Neutral Atom Beam technology.

17 Jul 2018

FDA expands its support for states to implement FSMA Produce Safety Rule

The U.S. Food and Drug Administration today announced new cooperative agreements with Hawaii, Kentucky and Mississippi, as well as renewed agreements with 43 other states, in support of efforts to implement the FDA Food Safety Modernization Act Produce Safety Rule, which establishes science-based minimum standards for the safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption.

13 Jul 2018

Researchers investigate how genetic data can be made accessible in medical practice

In a project funded by the Austrian Science Fund FWF, a research group from Vienna investigated how genetic data can be made accessible in medical practice in order to improve the safety and effectiveness of medication.

10 Jul 2018

Tufts engineers develop smart bandages to monitor and deliver treatment for chronic wounds

A team of engineers led by Tufts University has developed a prototype bandage designed to actively monitor the condition of chronic wounds and deliver appropriate drug treatments to improve the chances of healing.

6 Jul 2018

Key innovations awards recognize PENTAX Medical for new product developments

PENTAX Medical is pleased to announce that the innovation within its new product developments has been recognized by two key awards.

From PENTAX Medical Company 6 Jul 2018

Effective molecular labeling to identify biomedical implants inside living being

A team of researchers at CNRS, Aix-Marseille Université and Université Paris 13 has demonstrated effective molecular labeling to unequivocally identify biomedical implants, even after a prolonged period inside the living being. These results were published in Angewandte Chemie International Edition on July 5, 2018.

6 Jul 2018

ASCO and ESMO urge governments to improve cancer care and reduce deaths

The European Society for Medical Oncology and the American Society of Clinical Oncology, the world's two leading organizations for oncology professionals, today issued a joint statement calling upon governments to renew political commitment to improve cancer services and reduce cancer deaths.

5 Jul 2018

Candida Auris testing kit for use in hospital hygiene applications announced by Bruker

At the International Society for Human and Animal Mycology meeting, Bruker announces Fungiplex™ Candida Auris, a new research-use-only, real-time PCR assay and kit for the detection of Candida auris in hospital hygiene applications.

From Bruker Daltonics 4 Jul 2018