Medical Devices News and Research

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Researchers develop new testing device to better diagnose dizziness

Half of over-65s suffer from dizziness and problems with balance. But some tests to identify the causes of such problems are painful and can risk hearing damage.

10 Sep 2018

Mycovia initiates two Phase 3 clinical trials to evaluate VT-1161 in patients with RVVC

Mycovia Pharmaceuticals, making its official debut as a company developing therapies in women's health and dermatology, today announced the initiation of two Phase 3 clinical trials called VIOLET to evaluate the safety and efficacy of its lead candidate, VT-1161, in patients with recurrent vulvovaginal candidiasis

6 Sep 2018

TransEnterix files FDA 510(k) submission for its new Senhance Ultrasonic Instrument System

TransEnterix, Inc., a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced the Company filed a FDA 510(k) submission for its Senhance Ultrasonic Instrument System.

6 Sep 2018

Superbugs emerging from skin bacteria on the increase

A new study has shown that some of the sub-strains of the bacteria that commonly live on our skin have become resistant to common infections – or in other words turned into superbugs. Infections with these strains thus could become untreatable with the antibiotics available and may turn life-threatening, warn researchers.

6 Sep 2018

Study: First independent in-home use of brain-computer interface by ALS patients shows promise

Laboratory studies have shown the potential for patients with amyotrophic lateral sclerosis, who cannot move or speak, to communicate using a brain-computer interface.

30 Aug 2018

Scientists demonstrate how medical test results can be remotely modified

A team of physicians and computer scientists at the University of California has shown that it is easy to modify medical test results remotely by attacking the connection between hospital laboratory devices and medical record systems.

29 Aug 2018

New system that uses AI accurately detects patients with diabetic retinopathy

A system designed by a University of Iowa ophthalmologist that uses artificial intelligence to detect diabetic retinopathy without a person interpreting the results earned Food and Drug Administration authorization in April, following a clinical trial in primary care offices.

28 Aug 2018

New minimally-invasive surgical technique may be most significant development in dialysis

A new minimally-invasive surgical technique for dialysis patients may be the most significant development in dialysis access in the last 50 years, according to the surgeon who performed the first two cases in the United States.

28 Aug 2018

ITL Group announces completion of SMT manufacturing upgrade

Experienced medical device design, development, and manufacturing partner, ITL Group has announced further investment in its on-site PCB manufacturing facility.

From Vitl Life Science Solutions 24 Aug 2018

Researchers successfully reproduce effects of traumatic brain injury in petri dish

Researchers in the University of Georgia's Regenerative Bioscience Center have succeeded in reproducing the effects of traumatic brain injury and stimulating recovery in neuron cells grown in a petri dish.

24 Aug 2018

FDA grants Breakthrough designation to Dthera Sciences' development-stage product for Alzheimer's

Dthera™ Sciences, the leading digital therapeutic company focusing on the elderly and individuals with neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to the Company's development-stage product, DTHR-ALZ.

24 Aug 2018

Far-UVC light could help prevent catheter-based and driveline infections

A specific wavelength of ultraviolet light, now delivered through light-diffusing optical fibers, is highly effective at killing drug-resistant bacteria in cell cultures, according to a new study led by David J. Brenner, PhD, a professor of radiation biophysics at Columbia University Vagelos College of Physicians and Surgeons.

24 Aug 2018

Mercy Medical Center announces installation of premium Resona 7 ultrasound machines

Mercy Medical Center, a nationally recognized medical facility, has announced the installation of five premium Resona 7 ultrasound machines from Mindray for the hospital's Vascular Center, Paul R. Lucas, M.D., FACS, RPVI, Director, The Vascular Center at Mercy has announced.

23 Aug 2018

BrainsWay receives FDA clearance for Deep TMS system to treat adults with obsessive-compulsive disorder

BrainsWay Ltd., the parent company of BrainsWay USA, Inc., and a global leader in the advanced non-invasive treatment of brain disorders, today announces that it has received De Novo clearance from the U.S. Food and Drug Administration (FDA) for its deep transcranial magnetic stimulation (Deep TMS) system for the treatment of obsessive-compulsive disorder (OCD) in adults.

22 Aug 2018

CERENOVUS wins European CE mark approval for BRAVO Flow Diverter to treat intracranial aneurysms

CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, announced today it has received European CE mark approval for its BRAVO Flow Diverter. The device is approved for use in the treatment of patients suffering from intracranial aneurysms.

22 Aug 2018

Researchers raise serious concerns about the accuracy of two baby monitors

Researchers who tested two commercially available baby monitors are raising serious concerns about the accuracy of these products, which are marketed to parents, but are not regulated by the U.S. Food & Drug Administration.

21 Aug 2018

Tandem Diabetes Care introduces t:slim X2 Insulin Pump with Basal-IQ Technology in the US

Tandem Diabetes Care, Inc. , a medical device company and manufacturer of the only touchscreen insulin pumps with continuous glucose monitoring (CGM) integration, today announced its launch of the t:slim X2 Insulin Pump with Basal-IQ™ Technology, a predictive low glucose suspend (PLGS) feature designed to help reduce the frequency and duration of low glucose events (hypoglycemia).

17 Aug 2018

3D-printed human body parts to be used as teaching aids for surgical training

3D-printed human body parts with lifelike bone, skin and muscle densities are being developed in South Australia as teaching aids for surgical training.

17 Aug 2018

Hospitals battle for control over fast-growing heart-valve procedure

When Medicare in 2011 agreed to pay for a revolutionary procedure to replace leaky heart valves by snaking a synthetic replacement up through blood vessels, the goal was to offer relief to the tens of thousands of patients too frail to endure open-heart surgery, the gold standard.

17 Aug 2018

Digital birth control app gets FDA nod

Last week the United States Food and Drug Administration (FDA) announced its approval of the digital birth control app to be sold in the US. The app is called “Natural Cycles” and is one of the first medical devices of this kind to receive the FDA nod.

14 Aug 2018

Medical Devices News and Research

Researchers develop new testing device to better diagnose dizziness

Mycovia initiates two Phase 3 clinical trials to evaluate VT-1161 in patients with RVVC

TransEnterix files FDA 510(k) submission for its new Senhance Ultrasonic Instrument System

Superbugs emerging from skin bacteria on the increase

Study: First independent in-home use of brain-computer interface by ALS patients shows promise

Scientists demonstrate how medical test results can be remotely modified

New system that uses AI accurately detects patients with diabetic retinopathy

New minimally-invasive surgical technique may be most significant development in dialysis

ITL Group announces completion of SMT manufacturing upgrade

Researchers successfully reproduce effects of traumatic brain injury in petri dish

FDA grants Breakthrough designation to Dthera Sciences' development-stage product for Alzheimer's

Far-UVC light could help prevent catheter-based and driveline infections

Mercy Medical Center announces installation of premium Resona 7 ultrasound machines

BrainsWay receives FDA clearance for Deep TMS system to treat adults with obsessive-compulsive disorder

CERENOVUS wins European CE mark approval for BRAVO Flow Diverter to treat intracranial aneurysms

Researchers raise serious concerns about the accuracy of two baby monitors

Tandem Diabetes Care introduces t:slim X2 Insulin Pump with Basal-IQ Technology in the US

3D-printed human body parts to be used as teaching aids for surgical training

Hospitals battle for control over fast-growing heart-valve procedure

Digital birth control app gets FDA nod

Industry Focus eBook - Medical Devices (3rd Edition) eBook

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