Latest News
6 July
ResMed acquires diagnostics software provider Somnoware
Credit: New Africa/Shutterstock
Medical device company ResMed has acquired US-based sleep and respiratory care diagnostics software provider Somnoware for an undisclosed sum.
The software from Somnoware helps streamline physicians’ processes besides pulmonary and sleep function testing labs to diagnose and assess the respiratory and sleep care test outcomes of a patient.
It enables the scheduling of appointments, ordering of positive airway pressure (PAP) treatment equipment, tracking of PAP compliance and electronically integrating this information into a patient’s electronic health record directly.
ResMed Sleep and Respiratory Care president Lucile Blaise said: “We’re committed to driving wider adoption of Somnoware’s open and interoperable platform to help more people with OSA or COPD get the diagnoses and treatment solutions they need.”
ResMed aims to retain all the staff of Somnoware and integrate its offerings into its brand and solution ecosystem. The company also intends to maintain the open and device-agnostic nature of Somnoware’s products.
6 July
Abbott scores FDA approval for world’s first leadless dual-chamber pacemaker
Patients who require rhythmic assistance in two chambers of the heart now have the option of a leadless system, after the US Food and Drug Administration (FDA) approved Abbott’s AVEIR dual-chamber (DR) leadless pacemaker system.
The FDA nod came hot on the heels of clinical data announced by the medical device giant in May, demonstrating that 97% of participants had successful atrioventricular (AV) synchrony following device implant.
The AVEIR DR system is the first technology of its kind to consist of two pacemakers implanted directly into the heart myocardium without the need for leads. Traditional pacemakers require a more invasive procedure to install, and the limited lifespan of leads means that current systems last between 10 to 15 years.
There are leadless devices currently on the market, such as Medtronic’s Micra devices, but these are limited to single-chamber use. According to Abbott, 80% of patients who need a pacemaker require pacing in the right atrium and the right ventricle.
6 July
UK’s NICE recommends home tests for colorectal cancer detection
The UK’s National Institute for Health and Care Excellence (Nice) has recommended the use of home tests for people with signs or symptoms of colorectal cancer to reduce waiting times for a colonoscopy.
In a draft guidance released for consultation, NICE’s diagnostic advisory committee recommended the use of the HM-JACKarc or OC-Sensor quantitative faecal immunochemical tests (FIT). The amount of blood in the faeces is measured in a laboratory using a sample sent through the post.
Results are usually available within a week and people with haemoglobin levels of 10mg or more should be referred for further testing. The diagnosis of cancer requires further evaluation using colonoscopy or CT colonography. Some people presenting to primary care with colorectal cancer symptoms were already offered FIT under existing NICE guidelines, while others were immediately referred to a suspected cancer pathway. Everyone will now receive a FIT under the new draft guidance.
4 July
Verici releases results for Clarava, a kidney transplant rejection test
Verici Dx, a developer of clinical diagnostics for organ transplant, has seen successful validation results from its prospective, blinded, clinical validation study for Clarava, a pre-transplant prognostic test to measure a patient’s immune response and assess the risk of early kidney transplant rejection.
The test is based on RNA sequencing and uses artificial intelligence to work out an RNA signature from gene expression. Using just a simple blood draw, it will help clinicians to treat an estimated 65,000 eligible patients each year upon its commercial launch before the end of 2023.
Sara Barrington, CEO of Verici Dx, said: “It’s a fascinating new development in medical care and diagnostics. One of the things that we emphasize about RNA signatures is that it’s starting to move down a personalized medicine route.”
28 June
FDA issues recall of Teleflex catheter system
The US Food and Drug Administration (FDA) has recalled more than 260,000 catheter systems from Teleflex in a Class I recall after reports the device was prone to separation or leakage.
Made under Teleflex’s subsidiary Arrow International, the issues with Arrow Endurance Dwell Peripheral Catheter System have been identified as a potential cause for serious injury or death.
The FDA stated that if the catheter breaks whilst in a blood vessel, fragments from the device could travel to other parts of the body, causing a heart attack or a pulmonary embolism.
So far, Teleflex/Arrow International has received 83 complaints, with 18 reported patient injuries. No deaths have been reported yet. As per a Class I recall, any distributors of the device will have to pull the products and return them to Teleflex. For medical facilities using the catheter, use of the device should be stopped, and the items quarantined.