Tethis enrols first two subjects in trial of See.d instrument
Tethis is set to gain insights from analytical characterisation of liquid biopsy samples from MBC patients. Credit: Komsan Loonprom/Shutterstock.com. Tethis has announced the enrolment of the first two patients in the TET-22-001 clinical study of its See.d platform. Being conducted at the European Institute of Oncology in Milan, Italy, the study is designed to assess […]
Partnerships are key to driving digital healthcare transformation in US, say experts
Credit: Shutterstock Partnerships between different stakeholders in the healthcare industry are crucial for driving healthcare transformation. Stakeholders can include diverse groups – not just payors, governments and providers, but also pharma companies, academic centers and private practices. But by working together, these stakeholders can address challenges such as treating complex diseases, reducing costs, and increasing […]
Protembis enrols first patient for ProtEmbo System trial
The trial will include 250-500 randomised patients across the US and Europe. Credit: Monkey Business Images/Shutterstock.com. German cardiovascular medical device company Protembis has enrolled the first patient in its PROTEMBO investigational device exemption (IDE) pivotal trial of the ProtEmbo System. The ProtEmbo System is a cerebral embolic protection device used during transcatheter aortic valve replacement […]
FDA approves Abbott TriClip system for tricuspid valve repair
TriClip is delivered via a vein in the leg and works by clipping together parts of the valve’s leaflets to reduce regurgitation. Credit: Abbott/PRNewswire. The US Food and Drug Administration (FDA) has granted approval for Abbott’s TriClip transcatheter edge-to-edge repair (TEER) system for leaky tricuspid heart valves. This device is specifically designed to treat tricuspid […]
Can digital technology address US healthcare challenges?
Credit: Shutterstock The US healthcare system is facing several challenges, including rising costs, clinician shortages, and the need for improved efficiency and effectiveness. Digital healthcare can help address these challenges by leveraging technologies such as telehealth, remote patient monitoring, health apps, and AI solutions. Importantly, digital healthcare can also improve access to care, especially for […]
Partnerships are key to driving digital healthcare transformation in US, say experts
Credit: Shutterstock Partnerships between different stakeholders in the healthcare industry are crucial for driving healthcare transformation. Stakeholders can include diverse groups – not just payors, governments and providers, but also pharma companies, academic centers and private practices. But by working together, these stakeholders can address challenges such as treating complex diseases, reducing costs, and increasing […]
Concept wins another IDE from FDA for MagicTouch range
Repeated blockages in AVFs can occur in patients undergoing multiple haemodialysis procedures. Credit: ustas7777777 via Shutterstock. The US Food and Drug Administration (FDA) has granted Concept Medical an investigational device exemption (IDE) for its MagicTouch arteriovenous fistula (AVF) catheter, allowing the company to initiate a clinical study with the device. The IDE is for the […]
Abbott’s bedside concussion blood test scores FDA clearance
The portable i-STAT TBI cartridge uses whole blood to screen for serum biomarkers to inform the need for conducting CT test in patients with suspected concussion. Image Credit: Ground Picture / Shutterstock. The US Food and Drug Administration (FDA) has cleared Abbott’s i-STAT TBI cartridge for assessing patients with suspected concussion or mild traumatic brain […]
Laborie invests in CarePath uroflow device developer iO Urology
The I-O Urology’s CarePath digital diagnostic platform. Credit: Business Wire/ iO Urology Corp. Laborie Medical Technologies has announced an investment in I-O Urology, the developer of the CarePath uroflow device. The US Food and Drug Administration (FDA)-approved, at-home diagnostic tool, CarePath, aims to reduce urinary tract symptoms (LUTS) treatment. Eligible for remote patient monitoring reimbursement, […]
Fractyl Health receives IDE approval for Revita trial
The Remain-1 trial will enrol patients on tirzepatide who have lost at least 15% in total body weight. Credit: grinny via Shutterstock. US-based biotech Fractyl Health has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct a clinical trial of its Revita endoscopy system, the same day it […]