September's top stories: New NGS oncology test, Royal Philips’ Affiniti launch

Thermo Fisher, GSK and Pfizer partner for new NGS oncology test, Roche introduces global access programme to combat AIDS, TB and malaria, and Royal Philips launches new Affiniti ultrasound system. Medicaldevice-network.com wraps up key headlines from September 2014.


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Thermo Fisher, GSK and Pfizer partner for new NGS oncology test

Thermo Fisher Scientific entered into partnership with GlaxoSmithKline (GSK) and Pfizer to develop a universal next-generation sequencing (NGS) oncology test for solid tumours, which can be used as a companion diagnostic for multiple drug programmes.

The new test will be developed using the company's Ion Personal Genome Machine (PGM) Dx Platform, Ion AmpliSeq technology, and content from the Oncomine Cancer Research Panel.

After successful development and validation of the test, the company plans to submit this test for premarket approval to the US Food and Drug Administration (FDA) and other global regulatory authorities.

Roche introduces global access programme to combat AIDS, TB and malaria

Swiss global health-care firm Roche launched a global access programme for HIV viral load testing to combat AIDS, tuberculosis (TB) and malaria.

The programme has been created in partnership with UNAIDS, the joint United Nations Programme on HIV/AIDS, the Clinton Health Access Initiative (CHAI), the President's Emergency Plan For AIDS Relief (PEPFAR) and the Global Fund.

The company has committed to provide its COBAS AmpliPrep/COBAS TaqMan HIV-1 Test version 2.0 through a special pricing scheme for qualifying organisations in eligible countries in order to support the global access programme.

Royal Philips launches new Affiniti ultrasound system

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Royal Philips launched a new ultrasound system, Affiniti, which allows physicians to treat large volumes of patients.

Affiniti features anatomical intelligent ultrasound that provides automatic anatomy recognition and quantification and PureWave transducer technology, which delivers better image quality.

The new system provides technology to help radiology/ultrasound departments serving more patients with fewer resources to deliver high quality patient care.

It also includes automation tools such as AutoSCAN, Auto Doppler and SmartExam, which will reduce the number of steps required to complete each exam, as well as features DICOM and PC format capabilities for seamless information-sharing.

Philips Imaging Systems Ultrasound CEO and senior vice-president Vitor Rocha said: "We have leveraged more than 45 years of ultrasound innovation to deliver a reliable system that combines the excellent image quality our customers expect for fast, confident diagnosis, with advanced tools to help them improve efficiency and workflow and allow for the very best standard of care."

Boston Scientific begins REPRISE III trial of Lotus Valve System

US-based Boston Scientific started a REPRISE III clinical trial designed to assess the safety and effectiveness of the Lotus Valve System in patients with severe aortic stenosis.

The trial will evaluate patients who are considered to be at either high or extreme risk for surgical valve replacement.

As part of the REPRISE III trial, a clinical team led by Dr Feldman implanted the first three Lotus Valve Systems at Evanston Hospital.

GE Healthcare's Discovery IQ system receives 510(k) clearance from FDA

The US Food and Drug Administration (FDA) granted 510(k) clearance for GE Healthcare's Discovery IQ PET/CT system.

GE Healthcare said that the new system can image with both half the Positron emission tomography (PET) dose and half the scan time.

The new system with Q.Clear technology has been developed to provide accurate quantitation (SUVmean) with better image quality (SNR) for small lesion detection, fast and efficient reading, and a confident diagnosis.

Abbott begins ABSORB IV heart stent clinical trial

Healthcare company Abbott started the ABSORB IV clinical trial to test the cost-effectiveness of its medical device Absorb bioresorbable vascular scaffold (BVS), which is used in the heart to function such as a stent.

The ABSORB IV trial will compare the device with a permanent metallic drug eluting stent in people with coronary artery disease.

Absorb is the world's first drug eluting BVS that works similar to a metallic stent by opening up blocked blood vessels in the heart and restoring blood flow. Once it completes its function, the polylactide-made Absorb dissolves completely over time.

St Jude Medical reports positive 12-month data from EnligHTN III trial

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St Jude Medical reported positive 12-month outcome data from the EnligHTN III study, which demonstrated continuation of safe, rapid and effective treatment with the next-generation EnligHTN Renal Denervation System for patients with drug-resistant, uncontrolled hypertension.

Renal denervation is a specialised ablation procedure that reduces blood pressure for patients with hypertension, or high blood pressure, that is resistant to medical therapy.

The EnligHTN system delivers radiofrequency (RF) energy from an ablation catheter to create lesions along the renal nerves, a network of nerves in the walls of the renal arteries said to help control blood pressure.

Apollo Hospitals and AliveCor partner for mobile ECG device

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India's Apollo Hospitals entered an exclusive collaboration with US-based AliveCor to introduce smartphone-enabled, medical grade and FDA-cleared AliveCor Heart Monitor in India and South Asia to tackle the growing problem of heart arrhythmias.

The product's launch is part of Apollo Hospitals' arrhythmia screening and stroke prevention programme providing patients with access to this device.

The new AliveCor Heart Monitor will improve access to cardiac screening tools for patients across India and is compatible with iOS and Android mobile devices to wirelessly record, display, store and transfer heart rate and single-channel electrocardiogram (ECG).