UNIVERSITY OF PENNSYLVANIA DEVELOPS ODOUR TEST FOR HARD-TO-DETECT CANCERS

02 june | device development

Scientists at the University of Pennsylvania (Penn) and its Perelman School of Medicine in the US have developed an odour-based test to precisely identify hard-to-detect cancers.


In a study, the test was able to detect and differentiate between benign and pancreatic or ovarian cancer cells with an accuracy of up to 95%.


Named e-nose, the test leverages artificial intelligence (AI) and machine learning to interpret the mixture of volatile organic compounds (VOCs) generated by cells in blood plasma samples.


The test could potentially become a non-invasive method to assess hard to identify cancers, the researchers said. The electronic olfaction tool has nanosensors that can identify the composition of VOCs, which are emitted by all cells.


Earlier studies have shown that VOCs released from tissue and plasma from ovarian cancer patients are different from those released from samples of benign tumour patients.


Penn physics and astronomy professor A T Charlie Johnson said: “It’s an early study but the results are very promising. The data shows we can identify these tumours at both advanced and the earliest stages, which is exciting.


“If developed appropriately for the clinical setting, this could potentially be a test that’s done on a standard blood draw that may be part of your annual physical.”


To analyse the accuracy, a total of 93 patients were assessed. It included 20 ovarian cancer patients, 20 people with benign ovarian tumours and 20 age-matched controls with no cancer.

In addition, the study involved 13 pancreatic cancer patients, ten people with benign pancreatic disease and ten controls.


The university noted that the vapour sensors were able to distinguish the VOCs from ovarian cancer and pancreatic cancer with an accuracy of 95% and 90%, respectively. Furthermore, the device detected all patients with early-stage cancers.

01 june | technology

ILLUMINA AND NGG THAILAND TO INTRODUCE NIPT SOLUTION

Illumina and Next Generation Genomic (NGG Thailand) are set to launch a next-generation sequencing (NGS)-based VeriSeq NIPT Solution v2 in the country.

The CE-IVD marked, automated in-lab solution is said to deliver precise, rapid and scalable end-to-end, genome-wide, non-invasive prenatal testing (NIPT).

It will permit NGG Thailand to introduce the Qualifi Prenatal Test and become the first lab in South East Asia to identify anomalies that are missed by targeted assays.

Against traditional NIPT offerings, the test could offer additional insights into the health of a pregnancy.

Leveraging Illumina’s NIPT solution, the test provides a complete view of the foetal genome when compared with other CE-IVD NIPT products. 

This facilitates healthcare professionals to provide expectant parents with informed, timely and tailored pregnancy management options.

31 May | technology

ORTHOPEDIATRICS INTRODUCES NEUROMUSCULAR SCOLIOSIS SYSTEM

OrthoPediatrics has launched its RESPONSE Neuromuscular Scoliosis System for treating neuromuscular scoliosis in paediatric patients.

The RESPONSE NM system, which received 510(k) clearance from the US Food and Drug Administration last year, will be introduced on a full scale in the coming months.

OrthoPediatrics noted this surgical system is the 36th system to be launched by the company.

Developed in collaboration with paediatric orthopaedic surgeons, this new system was designed to meet various challenges in treating paediatric patients.

RESPONSE NM builds on the company’s RESPONSE Spine System and consists of a set of implants and instruments with features that streamline insertion.

These include options for extreme hyperlordosis and sacral/pelvic fixation.

31 may | AI

NEC DEVELOPS AI TECHNOLOGY FOR BARRETT’S NEOPLASIA DETECTION

NEC Corporation has developed an artificial intelligence (AI) technology that can aid doctors in identifying neoplasia in Barrett’s oesophagus while performing endoscopic procedures.

The company noted that this software is the first of its kind to be CE mark-compliant. It is set to be launched as WISE VISION Endoscopy and will be made available in Europe soon.

The software is linked to endoscopy processors and alerts customers automatically on possible Barrett’s neoplasia from pictures taken during endoscopic procedures.

In addition, it features a visible user interface for intuitive action and facilitates doctors to continue with examinations effortlessly.

NEC worked with European Society of Gastrointestinal Endoscopy Research Committee chair professor Pradeep Bhandari to develop this AI software.

Bhandari noted: “Once the neoplasia is found, the system takes a still image and transfers it to the top right corner of a screen as a reference image for endoscopists.

“It doesn’t stop here, as it also has a heat map which shows the area of the AI-predicted neoplasia.”

Trained with nearly one million Barrett’s oesophagus endoscopy images, WISE VISION Endoscopy also includes the knowledge of specialised endoscopists.

28 may | finance

MEDTRONIC REPORTS 37% INCREASE IN Q4 FY21 REVENUE

Medtronic has reported global revenue of $8.188bn in the fourth quarter (Q4) of the fiscal year 2021 (FY21), a surge of 37% on reported and 32% on an organic basis from $5.998bn in the same quarter last year.

The company said that these results, for the quarter ended 30 April, indicate a recovery from the Covid-19 pandemic’s impact on its elective procedures seen in April 2020.

The company’s GAAP net income and diluted earnings per share (EPS) in this quarter were $1.36bn and $1, respectively, an increase from $646m and $0.48 in the year-ago quarter.

Non-GAAP net income and non-GAAP diluted EPS also rose 162% and 159%, respectively, from  $777m to $2.04bn and $0.58 to $1.50.

In the US, the company recorded a 47% year-on-year increase in revenue to $4.182bn, representing 51% of the total revenue this quarter.

The revenue in the non-US developed market rose 20% to $2.672bn while emerging markets revenue stood at $1.334bn with a 44% surge.

28 may | technology

ADVANCED HUMAN IMAGING’S DERMA AI GAINS CE MARK APPROVAL

Advanced Human Imaging (AHI) has obtained a CE mark in the EU for its Derma AI integrated with the DermaScan for the dermatology artificial intelligence (AI) component in CompleteScan.

Developed by Canadian company Triage Technologies, the Derma AI component (DermaScan AI) can precisely categorise skin conditions from a picture taken on a standard smartphone camera.

The Derma AI can group 588 common or rare skin conditions into 133 categories, which includes all types of skin cancer, by leveraging Triage’s dermatological AI database.

AHI signed a binding licencing and investment agreement with Triage to integrate Derma AI into AHI’s CompleteScan SaaS platform in April.

This deal provided AHI with a strategic equity stake in Triage and worldwide distribution rights to the combined device called DermaScan.

The device will aid dermatologists, doctors and nurses in obtaining a quick second opinion and improve detection of dermatologic conditions using a smartphone.

In brief

FDA GRANTS CLEARANCE TO ENDOFRESH ENDOSCOPY SYSTEM 

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Chinese company EndoFresh’s Disposable Digestive Endoscopy System for gastrointestinal purposes.

QUIDEL’S COVID-19 TEST GETS HEALTH CANADA APPROVAL 

Health Canada has authorised Quidel’s Sofia SARS Antigen FIA for serial testing to identify active Covid-19 infection in symptomatic and asymptomatic people.

BOSTON SCIENTIFIC GETS CE MARK FOR SINGLE-USE BRONCHOSCOPE

Boston Scientific has obtained CE mark for its EXALT Model B Single-Use Bronchoscope, a device meant for bedside procedures in the intensive care unit, operating room and bronchoscopy suite.


The company plans to introduce the bronchoscope soon, with a limited launch in Europe.

GENESIS MEDTECH RAISES SERIES B FUNDS TO DEVELOP NEW PRODUCTS

Genesis MedTech has raised growth financing from Series B funds to accelerate the research and development of various products as well as the marketing of current products.


The financing round, led by growth equity company General Atlantic, saw participation from CITIC Capital among others.

BREATHONIX’S COVID-19 BREATH TEST GETS PROVISIONAL APPROVAL IN SINGAPORE

The Health Sciences Authority of Singapore has provisionally authorised Breathonix’s BreFence Go Covid-19 Breath Test System for accurate disease identification in a minute.


A spin-off firm from the National University of Singapore, Breathonix developed the breath test system to identify volatile organic compounds in an individual’s exhaled breath.

27 may | Diabetes care

MEDTRONIC OBTAINS CE MARK FOR GUARDIAN 4 SENSOR AND SMART INSULIN PEN

Medtronic has obtained CE mark for prolonged use of its InPen smart insulin pen for multiple daily injections (MDI) and its Guardian 4 sensor for better diabetes management.

The latest approval permits the Guardian 4 sensor, which does not need fingersticks for calibration or diabetes treatment decisions, to be used with either the InPen, the MiniMed 780G insulin pump system or as a separate continuous glucose monitoring (CGM) device.

The company noted that the InPen, which is linked to real-time CGM through a smartphone app, is the first-ever smart insulin pen to get approval in Europe.

The smart MDI system can record insulin doses, check active insulin and suggest mealtime and correction doses using an auto-populated bolus calculator.

Connecting InPen with the Guardian 4 CGM system is meant to offer real-time glucose levels and notifications together with insulin dose data. This will help users better manage their diabetes.

In addition, the insulin dose and glucose reports can be sent to care partners and healthcare specialists.

26 may | BUSINESS & REGULATION

SWISS MEDTECH COMPANIES LOSE ACCESS TO DUTY-FREE EU TRADING

Switzerland medtech companies will no longer be able to export duty-free to the EU, after Bern and Brussels failed to agree to a long-anticipated trade treaty.

Economic ties between Switzerland and the EU will continue to be governed by over 100 bilateral agreements stretching back to 1972, as the two sides have been unable to agree on a single international treaty to govern their relationship.

An accord with Switzerland’s biggest trading partner on mutual recognition of industrial standards, which facilitates the trade of medtech products across borders, has now expired after talks to extend it fell apart.

The Swiss Government said it has agreed to create transition periods before manufacturers from the EU would have to appoint authorised representatives in Switzerland and label products with this information.

Switzerland exports more than $5.6bn worth of medical devices to the EU, and imports over $3bn. The sector accounts for around 3% of Switzerland’s GDP and employs over 60,000 people.

Sector lobby group Swiss Medtech, which represents 1,400 companies, has criticised the loss of seamless access to the single market.