April's top stories: Aethlon cancer clinical trial, Sectra buys it-mark

Aethlon Medical and UCI enter cancer clinical trial agreement, Siemens Healthcare launched a new portable and compact Acuson P500 ultrasound system and Sectra is to acquire Denmark’s medical IT services provider, it-mark. Medicaldevice-network.com wraps up key headlines from April.


top april

Aethlon Medical and UCI enter cancer clinical trial agreement

hemopurifier

US-based therapeutic devices developer Aethlon Medical entered an investigator-initiated cancer clinical trial agreement with the University of California (UCI), Irvine, US.

As part of the deal, a clinical study protocol entitled 'Plasma Exosome Concentration in Cancer Patients Undergoing Treatment' will enroll 45 patients, five individuals in each of nine defined tumour types.

According to the company, the Hemopurifier is a first-in-class bio-filtration device that targets the single-use removal of viruses and tumour-derived exosomes from the circulatory system.

Siemens launches new ultrasound system for rapid imaging

acuson p500

Siemens Healthcare launched a new portable and compact Acuson P500 ultrasound system, Frosk edition, which will allow rapid imaging in an emergency setting.

Designed for use in emergency settings, the portable hand-held system can be easily positioned in different clinical environments and can image in less than 30 seconds.

The system can be applied for general imaging such as abdominal, small parts, renal, pelvic, vascular, 2D obstetrics and gynaecology or basic evaluation of cardiac functions, in addition to emergency medicine and acute care.

SynCardia receives FDA approval to conduct new IDE trial of 50cc Total Artificial Heart

syncardia

SynCardia Systems received US Food and Drug Administration (FDA) approval to conduct an investigational device exemption (IDE) clinical trial on the effective use of its 50cc temporary Total Artificial Heart in heart failure patients.

According to the company, all patients in the trial must be eligible for donor heart transplant and this secondary arm is expected to further characterise the use of the 50cc SynCardia Heart.

In the trial, images of patients' chest cavities will undergo 3D modelling, in order to better understand the patient populations to benefit from the 50cc Total Artificial Heart.

Tendyne starts patient enrolment in US transcatheter mitral valve replacement trial

US-based medical device firm Tendyne Holdings started patient enrolment in its multi-centre global feasibility trial of its Tendyne Bioprosthetic Mitral Valve (TMVR) system in patients with symptomatic mitral regurgitation of degenerative or functional etiology.

The TMVR system is designed to offer physicians total control during the procedure with a device that is fully repositionable and retrievable.

The trial is designed to provide early insights into the safety and performance of the Tendyne Bioprosthetic Mitral Valve system in these patients.

Sectra to acquire Denmark's medical IT services provider it-mark

Sweden-based Sectra announced plans to acquire Danish company it-mark, which sells medical IT services to healthcare providers.

The Danish company has been a distributor for Sectra since 2007 and its acquisition will bolster Sectra's presence in Denmark.

Following the acquisition, the operations of it-mark will join Sectra's Imaging IT Solutions business area, which develops and sells IT solutions and services that enable medical images to be managed.

University of Bath develops new biochip device for cancer drug development

A team of researchers from the University of Bath developed PhosphoSense biochip device, which will help speed up the discovery of new life-saving drugs in a more cost-effective way.

Used to screen compounds for use in new drugs, the PhosphoSense biochip can detect activity of enzymes called kinases, which regulate a number of important biological processes in normal healthy human cells for survival.

By monitoring the activity of enzymes, the biochip can allow drug companies to measure the effect of a large number of compounds, helping researchers choose which should be developed into drugs to fight against diseases.

Luminex launches new NxTAG RUO test for respiratory testing

US-based biotechnology firm Luminex launched a new NxTAG Respiratory Pathogen Panel (RUO) test, which enables laboratories to simultaneously detect 22 respiratory pathogens in a single closed tube system.

The assay accommodates higher throughput required to respond to seasonal changes in demand.

The new respiratory assay needs only a few minutes and no upstream reagent preparation, while extracted samples are added directly to pre-plated, lyophilised reagents.

FDA grants 510(k) clearance to AirStrip's Sense4Baby for patient self-administration

sense4baby

US-based AirStrip Technologies received a second 510(k) clearance from US Food and Drug Administration (FDA) for Sense4Baby wireless maternal l/ fetal monitoring system for use by pregnant patients to self-administer non-stress tests (NST).

Sense4Baby is a maternal and fetal monitoring product developed by West Health and later acquired by AirStrip.

AirStrip president Matt Patterson said: "AirStrip Sense4Baby can supplement care for patients with a prescribed need for NSTs that, with proper training and a care team's interpretation of data, offers a safe, convenient and cost-effective monitoring method in settings beyond hospital walls.

"Sense4Baby is a natural extension of AirStrip ONE, creating a new avenue for seamless mobile monitoring that can connect patients with their care team, while encouraging true patient engagement and peace of mind."