Device Area

The FDA approved JenaValve’s Trilogy HeartValve for treating severe aortic regurgitation, marking it as the first TAVR device for this condition in the US. The approval, which followed promising clinical results, is significant for patients with limited options due to high surgical risks.

HeartBeam’s CEO says the strength of clinical data convinced the US FDA to reverse course and grant clearance to his company’s innovative ECG device, which he says can assess arrhythmias at home with hospital accuracy.

CMS has reopened the TAVR coverage memo to consider coverage for without symptoms aortic stenosis and pure regurgitation. Stakeholders want to relax CED requirements and update NCD to include newer FDA-approved TAVR devices, improving patient access and outcomes in valvular heart disease treatment.

The US FDA has issued an early alert concerning Abiomed’s Impella purge cassettes, a critical heart pump component that delivers rinsing fluid to the Impella catheter.

Medtech Insight spoke with Rambam Medical Center’s Michael Mimouni, who implanted the first 3D-bioprinted corneal graft in a human patient, about his hopes for Precise Bio’s approach. The patient is part of a Phase I trial evaluating PB-001 in patients with corneal edema.

Roche Diagnostics, Intuitive Surgical, Abbott and Edwards Lifesciences all acknowledge tariff headwinds, but stress preparedness, resilience and mitigation. Below is look at how management framed the impact in Q1 vs Q2 earnings calls.

Combination products are no longer fringe – they are the “new normal,” consultant Stephen O’Rourke told Medtech Insight. The EU has the expertise to handle the regulatory complexity, but only if connects the dots between silos. That’s the challenge, he said, and the opportunity.

The US FDA says Baxter has notified customers about an issue with its Novum IQ Syringe Pump that is linked to two deaths and multiple injuries.

After its IPO, MiniMed has its first FDA clearance as a public company. The MiniMed Flex – smaller, screenless, and smartphone-controlled – is the product the newly independent diabetes firm needed to shift the conversation from market debut to market execution.

A turbulent market backdrop, geopolitical shock following the US and Israel striking Iran days before pricing, and a limited public float is likely to have weighed on investor appetite.

Medtronic plans to retain about 90% of the newly standalone MiniMed. While MiniMed’s 2025 revenues totaled $2.7bn, the company still posted a net loss amid strong competition from Abbott and Dexcom and recently announced more than six dozen layoffs at its California plant.

The US FDA says incorrect code messages from some Trividia glucose measurement devices could result in delayed treatment and serious patient harm.

During an ECRI-hosted webinar on AI-enabled diagnostics, a panel of experts discussed the promise and risks that come with the technology for both physicians and patients alike.

Numares Health bets on a metabolomics-based urine test to help doctors detect kidney transplantation rejection earlier than current biomarkers, which would allow doctors to intervene earlier in trying to save the transplanted organ.

As AI becomes ubiquitous in diagnosing diseases, clinicians must balance the technology’s enormous upside, such as improving the speed and accuracy of diagnoses, with the potential for errors that can lead to delayed or missed treatment.

HeartBeam’s CEO says the strength of clinical data convinced the US FDA to reverse course and grant clearance to his company’s innovative ECG device, which he says can assess arrhythmias at home with hospital accuracy.

Numares Health bets on a metabolomics-based urine test to help doctors detect kidney transplantation rejection earlier than current biomarkers, which would allow doctors to intervene earlier in trying to save the transplanted organ.

A new final guidance document from the US FDA lays out premarket considerations for devices intended to help treat obesity, including clinical trial design, labeling, and safety concerns. The guidance also calls for sponsors to consider patient perceptions in evaluating device effectiveness.

The system, which can be swallowed in a physician’s office and does not require surgery, has been cleared for use in adults aged 22-65 who have failed in at least one weight loss program.

The US FDA has issued an early alert concerning some Axios stent and delivery systems used in endoscopic drainage procedures after receiving reports of serious injuries and deaths linked to the device.

Cognito Therapeutics has revealed data from its OVERTURE feasibility study backing up the ability of its non-invasive Spectris headset to treat Alzheimer’s via the stimulation of gamma oscillations. The company is hoping to launch the device in 2027

Paradromics has launched a new academic-industry collaboration with leading brain-computer interface researchers at Stanford, Mass General, Pitt, UC Davis and Michigan aiming to translate BCI research into devices to help people with speech impairment, stroke and Parkinson’s.

Cognito Therapeutics closed a new funding round to advance its Alzheimer’s headset toward FDA De Novo submission and planned 2027 launch while expanding its Brain Health Collaboratory to support adoption, reimbursement innovation, and pipeline growth.

Device-based neurotherapeutics face a coverage gap that drug developers do not, and as the field moves toward combination approaches, that asymmetry could undermine important innovation.