DYANSYS RECEIVES US FDA APPROVAL FOR FIRST RELIEF NEUROSTIMULATION DEVICE

DyAnsys received US FDA approval for its percutaneous electrical neurostimulation (PENS) device, called First Relief, to treat diabetic neuropathic pain.

First Relief is for symptomatic relief of chronic, intractable pain related to diabetic peripheral neuropathy through multiple treatments for up to 56 days.

Placed behind the ear, the wearable device provides continuous pulses of low-level electrical current for several days.

The regulatory approval was based on data obtained from a randomised, double-blind prospective study, which was conducted with 63 participants aged between 30 and 74 years.

In the study, First Relief was evaluated against a placebo, as well as another device that had previously been approved by the US FDA.

FDA GRANTS BREAKTHROUGH DEVICE DESIGNATION FOR T2 BIOSYSTEMS’ T2LYME PANEL

The US FDA granted breakthrough device designation for T2 Biosystems’ T2Lyme Panel.

A direct-from-blood molecular diagnostic test, the T2Lyme Panel was designed to detect the Borrelia burgdorferi, B. afzelii, and B. garinii bacteria, which cause Lyme disease, directly from a patient’s blood.

It runs on the FDA-cleared T2Dx Instrument and was developed to support early diagnosis.

Early diagnosis allows appropriate treatments to be provided quickly, which helps prevent or reduce complications and significant costs associated with the disease.

According to preclinical data, the device provides superior accuracy compared to other diagnostics used for detecting Borrelia infections in patients that are suspected of having Lyme disease.

LIVEMETRIC SECURES FDA 510(K) CLEARANCE FOR LIVEONE BP MONITORING SYSTEM

LiveMetric received 510(k) clearance from the US FDA for LiveOne, a blood pressure monitoring technology.

LiveOne is a non-invasive, wrist-worn device that provides real-time measuring of blood pressure in patients with hypertension and cardiovascular diseases.

Without the need for any external calibration, the cuff-free device continuously extracts the pressure waveform from the radial artery.

It combines microelectromechanical system (MEMS) nanosensors with AI algorithms to provide blood pressure measurements.

Developed using a unique technological approach, the device uses a range of high-frequency nanosensors that help to process and sense actual pressure.

LiveOne uses machine learning to extract blood pressure values from the pulse waveform shape.

BLOOM DIAGNOSTICS INTRODUCES NEW INFLAMMATION TEST TO MEASURE CRP

Bloom Diagnostics introduced its Bloom Inflammation Test, which measures the C-Reactive Protein (CRP) in the bloodstream to detect inflammation.

Depending on sample CRP levels, the single-use, semi-automated testing kit gives five different classifications, ranging from normal to high-grade inflammation.

The test is designed to be used by professional clinicians. It allows testing for different ranges of CRP using a single drop of blood, with results obtained in minutes.

The process involves the collection of a pin-prick blood sample on a test strip, which is sent to the Bloom lab.

Cloud-based algorithms and AI technology combine results with other information, such as medical history, lifestyle, health status, and symptoms.

WALGREENS LAUNCHES INTERACTIVE TOOL TO TRACK COVID-19 VARIANTS

Walgreens has launched a new interactive tracking tool, the Walgreens Covid-19 Index, to advance the rapid detection of Omicron and track variant activity. It says the index can track the spread of the omicron variant within 24 to 48 hours.

The tool uses testing data from Aegis Sciences Corporation and uniquely identifies the spread of current and emerging virus variants in real-time.

The tool offers a snapshot of data for the past seven days based on positive tests analysed at more than 5,000 Walgreens locations across the nation.

According to the data collected and tracked by the tool, more than 95% of all positive cases of Covid-19 nationally are presumed to be the Omicron variant.