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FDA gives green light to Abbott’s insertable cardiac monitor

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An insertable Bluetooth-enabled cardiac monitor offering the world’s longest battery life has been cleared for use in the US by the country’s Food and Drug Administration.

Global healthcare player Abbott’s Assert-IQ will give physicians a new option for diagnostic evaluation and long-term surveillance of people experiencing irregular heartbeats.

Known as arrhythmias, the heart can beat too slowly, too quickly, or irregularly. Symptoms can include palpitations, feeling dizzy, shortness of breath, and fainting. The condition can affect anyone of any age.

There are various types of arrhythmias, but atrial fibrillation, where the heart beats irregularly and faster than normal, is most common in people over the age of 60, mainly because older people are at increased risk of cardiovascular disease. They also often take medications that affect the heart’s rhythm.

Diagnosing irregular heartbeats can be challenging in many patients, however, as the problem can be fleeting.

ICMs – small devices with sensors that are inserted just under the skin of the chest – are designed to provide constant, real-time monitoring of a person’s heart to detect and identify arrhythmias that can lead to the most common symptoms.

While many commercially available ICMs monitor a person’s heart rhythms for a few years, Assert-IQ offers two options with a battery life of at least three or six years to provide doctors with a new level of flexibility in diagnostic monitoring.

Chicago headquartered Abbott says while the three-year option may be preferred for more traditional monitoring, such as diagnosing fainting, heart palpitations or detections of abnormal heart rhythms, an option offering at least six years of battery life empowers medical practitioners to monitor long-term.

This monitoring can be especially important when caring for people who are undergoing therapy, have recently had a cardiac ablation procedure or who are at risk of developing further arrhythmias, such as atrial fibrillation.

The US Food and Drug Administration has given clearance to the Assert-IQ ICM.

In both options, advanced algorithms are available to detect irregular heartbeats and provide clinically actionable data.

Dhanunjaya Lakkireddy, medical director of the Kansas City Heart Rhythm Institute, a world-renowned arrhythmia care facility, has described the Assert-IQ ICM as a “significant advancement” amongst the tools currently available for the diagnoses of irregular heart beats.

He said: “Given that the device is small and is inserted just under the skin, patients can go about their daily lives, enjoying the activities they love, and the ICM does the work.

“With Assert-IQ ICM’s advanced algorithms, it can detect even hard-to-spot irregularities and help physicians determine a treatment course. It can be a very valuable tool both for short-term and long-term management of cardiac arrhythmia disorders.”

The device uses Bluetooth technology and is designed to remain connected to a transmitter – usually the person’s own smartphone – where it checks heart rhythms every 20 seconds, sending results in real-time to the clinic’s portal.

Additionally, some models of the Assert-IQ ICM family can be remotely programmed allowing the clinician to adjust the settings of the connected device, optimise performance and limit unnecessary alerts or transmissions – all without requiring the patient to make a clinic or hospital visit.

The Assert-IQ ICM also offers advanced diagnostic capabilities to provide medics with more clinically relevant information about the cardiovascular health of the patient, allowing them to make treatment decisions faster.

The Assert-IQ ICM is the latest addition to Abbott’s range of connected health devices, covering everything from cardiovascular products to diabetes care, diagnostics, neuromodulation, and nutrition. The company also has a portfolio of pharmaceuticals.

Leonard Ganz, divisional vice president of medical affairs and chief medical officer of Abbott’s cardiac rhythm management business, said: “As the incidence of abnormal heart rhythms like atrial fibrillation continue to rise, more doctors are turning to ICM technology to monitor their patients remotely to better detect the cause of symptoms that can impact overall health and quality of life.

“Until now, insertable cardiac monitors have allowed for remote monitoring of patients but lacked the longevity needed to monitor them long-term.

“Abbott’s Assert-IQ ICM offers physicians a connected health device that will help them provide the best care for their patients while making more accurate and informed treatment decisions.”

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Vision implant firm raises US$230m

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A vision implant firm has raised US$230m as it seeks approval in Europe and the US for a device that restored sight in a small clinical trial.

The Alameda, California-based startup said the funding would support commercialisation of its Prima device.

It said an upcoming launch is planned in Europe and that it would become the first brain computer interface company to have a vision restoration device on the market.

A clinical trial in Europe found the small implant could work as artificial photoreceptors in the retina to restore functional central vision.

The implant is placed under the retina to replace the function of light-sensitive cells lost to disease. A special pair of glasses with an embedded camera and infrared projector sends light signals to the implant.

The study assessed the system in people with advanced dry age-related macular degeneration.

Of the 38 patients who received an implant, 32 were assessed at 12 months. Results showed the device led to a clinically meaningful improvement in visual acuity in 26 people.

The patients were able to read letters, numbers and words, according to the company.

Science Corporation said it has submitted a CE mark application to the European Union and applied to the US Food and Drug Administration for regulatory approval.

Darius Shahida, chief strategy officer, said: “Our imperative is to become the first BCI company to scale and achieve profitability.”

Founded in 2021, the company has now raised about US$490m in total. It said it is expanding its clinical trial programme to include other retinal diseases, such as Stargardt disease and retinitis pigmentosa.

The Series C round included existing investors Khosla Ventures, Lightspeed Venture Partners, Y Combinator, IQT and Quiet Capital.

Science Corporation said demand for the round exceeded its capital needs, with funds also earmarked for expanding research, manufacturing infrastructure and operations.

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Nyra health raises €20m for digital neurotherapy

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Nyra health has raised €20m to scale its digital neurotherapy platform for neurological rehabilitation, targeting conditions such as stroke and dementia.

The Series A funding will be used to expand the company’s technology across the DACH region, accelerate its expansion into the US and support a more data-driven approach to neurorehabilitation.

Founded in 2021, Vienna-based nyra health has developed a certified medical device called myReha. Patients use the platform to train speech, cognition, fine motor skills and everyday abilities, supported by AI-driven real-time feedback.

The system analyses pathological speech, meaning speech affected by neurological damage, by assessing pronunciation, word retrieval, sentence structure and meaning. It also tracks reaction times, error patterns and training progress, adapting therapy automatically to a patient’s performance level and fatigue.

The company says neurological conditions including stroke, dementia and traumatic brain injury cost €65bn a year in Germany alone, largely because care often declines after patients are discharged from hospital.

Nyra health says myReha is used in more than 100 rehabilitation clinics and is reimbursed by 28 statutory and private health insurers, giving over 40m insured people access to structured, AI-based home therapy. According to the company, a randomised controlled study found that adding myReha to standard therapy led to greater improvements in language and cognitive function than standard therapy alone.

A companion tool, nyra insights, allows therapists to monitor language development, therapy intensity and progress in real time, adjust programmes and generate documentation automatically. An AI-supported Content Studio creates personalised therapy exercises based on individual performance data.

The funding round was led by Armira Growth, with existing investors Wellington Partners, Crane Venture Partners and EVER Pharma also participating. It follows a €4.5m seed round raised in 2023.

Moritz Schöllauf, chief executive and co-founder of nyra health, said:
“From the outset, our goal was to make our services widely available to those affected. Everyone who needs therapy after a stroke or other neurological disease should have access to effective, individualised care, regardless of where they live or how well their own healthcare system is set up. With this round of financing, we are taking another step in this direction.”

Christian Figge, managing partner at Armira Growth, said:
“Neurological rehabilitation can be made significantly more effective through digital solutions, especially in the area of speech ability. nyra health is considered a category creator with a proprietary AI-based solution that connects inpatient therapy, outpatient aftercare and home use.”

The company is also investing in multimodal AI models for therapeutic interaction and diagnostics as part of a €4.2m funded research project being developed with research universities in the US.

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Astellas and Vir strike prostate cancer deal

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Astellas has agreed a US$1.7bn global prostate cancer deal with Vir Biotechnology to develop a masked T-cell engager designed to harness the immune system against the disease.

The collaboration centres on VIR-5500, a PSMAxCD3 bispecific drug known as a T-cell engager, or TCE. TCEs activate immune cells called T cells and direct them to attack cancer cells.

Unlike radioligand therapies, which deliver radioactive material to tumours, TCEs aim to recruit the body’s own defences.

VIR-5500 targets PSMA, a protein found on prostate cancer cells, and uses what Vir calls PRO-XTEN dual-masking technology.

This is designed to keep the drug inactive until it is unmasked within the tumour, which the company says may limit side effects elsewhere in the body.

Vir says only about 30 per cent of patients with metastatic castration-resistant prostate cancer, an advanced form of the disease that no longer responds to hormone-blocking treatment, survive for five years after diagnosis.

Marianne De Backer, chief executive of Vir, said: “The field is moving very, very fast.

“And we believe that we could accelerate the programme by working together with someone who has a really strong track record in the space.”

Updated phase 1 data presented at the 2026 ASCO Genitourinary Cancers Symposium showed that 82 per cent of heavily pretreated patients receiving the highest evaluated doses achieved a 50 per cent or greater reduction in PSA levels, a marker of disease activity. Among patients with measurable tumours, 45 per cent recorded an objective response.

Cytokine release syndrome, an immune overreaction commonly associated with TCEs, was observed in 50 per cent of the 58 patients treated and was described by Vir as generally restricted to mild events.

The company said preventative steroids were not required and no drugs were used to manage severe CRS.

Under the agreement, Astellas will provide US$335m in upfront and near-term payments, including US$240m in cash, US$75m through an equity investment and a US$20m near-term milestone.

Vir is eligible for up to US$1.37bn in additional development, regulatory and sales milestones, along with tiered double-digit royalties on sales outside the US.

Development costs will be shared 60–40, with Vir holding an option to co-promote the drug in the US, while Astellas will be responsible for commercialisation elsewhere.

For Astellas, the deal may strengthen its position in prostate cancer as Xtandi, its partnered drug with Pfizer, begins to lose patent protection in several territories this year.

Vir licensed the underlying technology from Sanofi in 2024, meaning some proceeds from the agreement will be shared with the French pharmaceutical company.

Competition in the field remains strong. Novartis already markets its radioligand therapy Pluvicto, while Janux Therapeutics has a masked TCE that is currently ahead of VIR-5500 in development.

Amgen and Johnson & Johnson are also developing TCE candidates for prostate cancer.

Vir plans to move VIR-5500 into phase 3 trials in 2027 and to begin testing the drug in earlier-stage disease in the second quarter of 2026.

Johann de Bono, the phase 1 trial’s principal investigator and a prostate cancer expert at the Institute of Cancer Research in the UK, said: “It is remarkable to see these early signs of profound anti-tumour activity in heavily pretreated mCRPC patients, and the favourable tolerability with minimal CRS to date means VIR-5500 could play a role in treating earlier disease.”

Anthony Jarkowski, primary focus lead of immuno-oncology at Astellas, added: “What really stood out to us is how they’re balanced, efficacy and toxicity.”

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