January's top stories: Siemens smart hearing aids, Aethlon's Hemopurifier

Siemens unveiled new smart hearing aids at the 2015 International CES in Las Vegas, US.


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Siemens unveils new smart hearing aids

Siemens unveiled new smart hearing aids at the 2015 International CES in Las Vegas, US.

Claimed to be the latest in wearable hearing technology, the company's hearing aids can be discreetly controlled through iPhone and Android devices.

Siemens Hearing Instruments CEO Scott Davis said: "These are not your average hearing aids but rather highly-intelligent wearable devices.

"They automatically detect everyday listening environments such as a noisy room, wind, or while driving a car, and instinctively know what to do."

FDA approves Aethlon's Ebola treatment protocol

hemopurifier

The US Food and Drug Administration (FDA) granted approval for Aethlon Medical's clinical protocol to treat Ebola-infected individuals with its Hemopurifier in the US.

The Aethlon Hemopurifier is a bio-filtration device designed for the single-use removal of viruses and shed glycoproteins from the circulatory system of infected individuals.

Hemopurifier targets antiviral drug resistance and is a first-line countermeasure against Ebola and other viruses, which are not tackled with proven drug therapies.

Roche's cobas MRSA / SA Test secures FDA 510(k) clearance

Roche received 510(k) clearance from US Food and Drug Administration (FDA) for its cobas MRSA / SA Test for early and simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly from nasal specimens.

The company claims the test can detect both organisms from a single specimen, offering accurate results to control MRSA / SA infections.

The cobas MRSA / SA Test is a polymerase chain reaction (PCR) based assay, which runs on the automated cobas 4800 System.

FDA approves St Jude Medical's FlexAbility Ablation Catheter

The US Food and Drug Administration (FDA) granted approval for St Jude Medical's FlexAbility Ablation Catheter, a new ablation technology used by electrophysiologists to treat cardiac arrhythmias.

The catheter combines a bendable irrigated catheter tip with an advanced handle and next-generation shaft design, allowing effective lesion formation.

The company said that ablation catheters such as FlexAbility catheter, are thin and flexible wires used to treat irregular heartbeats that impair the heart's ability to effectively pump blood throughout the body.

FDA grants 510(k) clearance for Philips' Avalon CL

philips avalon

The US Food and Drug Administration (FDA) granted 510(k) clearance for Netherlands-based Royal Philips' Avalon CL Fetal Monitoring solution (Avalon CL).

The Avalon CL offers consistent monitoring of the mother and child, without the burden of managing cables, which enables mothers more freedom of movement during labour.

Allowing consistent monitoring while the mother is on the move, Avalon CL is said to continuously measure and transmit fetal heart rate and maternal pulse, uterine activity, and fetal or maternal electrocardiogram (ECG).

Covidien receives CE Mark for Stellarex DCB to treat peripheral arterial disease

Irish healthcare firm Covidien secured CE Mark for its Stellarex drug-coated angioplasty balloon (DCB), designed to restore and maintain blood flow to arteries in the the leg in patients with peripheral arterial disease (PAD).

The company said the Stellarex DCB is inserted into the diseased artery and inflated to open the vessel and restore blood flow, while a drug paclitaxel is deposited onto the vessel wall to prevent reoccurrence of new blockages.

The CE Mark is based on 24 month results of the ILLUMENATE First-in-Human (FIH) study, which showed a primary patency rate (ability to keep the artery open to restore blood flow) of 80.3%.

BiO2 Medical secures IDE approval to begin Angel Catheter trial

angel

US-based medical device manufacturer BiO2 Medical secured investigational device exemption (IDE) approval from US Food and Drug Administration (FDA) to start a clinical investigation of the Angel Catheter for pulmonary embolism (PE) protection.

The multicenter and single arm clinical investigation Angel Catheter trial is expected to enrol 182 subjects in 30 US investigational sites.

Patient enrolment is scheduled to begin in the first quarter of 2015, and the study will evaluate the safety and effectiveness of the catheter in subjects at high risk of PE, and with recognised contraindications to standard pharmacological therapy.

LifeScan launches OneTouch Verio Blood Glucose Monitoring System

US-based maker of blood glucose monitoring systems LifeScan has launched its new OneTouch Verio Blood Glucose Monitoring System, which enables diabetes patients to easily understand their results.

The easy-to-use system features a colour-coded range indicator, which shows whether a test result is within, below or above range limits set in the meter, eliminating the need to scroll or push buttons.

In addition, the system features high-resolution colour display with large on-screen results, and uses two replaceable AAA alkaline batteries that are included with each system.