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Category: Innovation


Innovation, Med Tech

How is Europe’s MedTech industry navigating the EU MDR?

January 11, 2024

Via: Medical Device Network

The technical documentation requirements of the EU’s Medical Device Regulation (EU MDR) can be exhaustive and resource-consuming. At the upcoming Outsourcing in Clinical Trials: Medical Devices Europe 2023 conference experts from across the industry will dissect the challenges and opportunities […]


Innovation, Research

Clinical Trial Payments: Optimizing the Path Forward for Site Payments

January 10, 2024

Via: HitConsultant

Escalating competition for clinical trial sites, in tandem with other industry-wide challenges such as changing regulations; a lack of bandwidth and resources; identifying ideal sites and recruiting and retaining patients, are posing significant obstacles for sponsors and site teams within […]


Innovation, Med Tech

Revolutionising healthcare: bioprinting takes a leap forward in 2024

January 10, 2024

Via: Medical Device Network

As we enter the new year, notable advancements in the field of medicine are unfolding. In 2024, a significant breakthrough is taking place as 3D-printing technology progresses to create fully functional human organs. This pivotal achievement has the potential to […]


Innovation, Medical Devices

Abbott and Tandem provide new option for diabetes management

January 9, 2024

Via: Medical Device Network

Abbott and Tandem Diabetes Care have announced the wireless integration of Abbott’s FreeStyle Libre 2 Plus continuous glucose monitor with the Tandem t:slim X2 insulin pump in the US. This announcement provides an additional treatment option for patients with diabetes […]


Innovation, Med Tech

Digital health funding last year reached lowest level since 2019: report

January 9, 2024

Via: Healthcare Dive

Digital health funding soared to record-breaking levels during the COVID-19 pandemic in 2021, boosted by the rapid uptake of telehealth and other digital health technologies that aimed to preserve access to care. But investment began to decline in 2022, and […]


Innovation, Research

Child seizures caught on video may be a clue to solving unexplained crib deaths

January 5, 2024

Via: Fox News

The last bedtime of 17-month-old Hayden Fell’s life was heartbreakingly normal. Crib video shows the toddler in pajamas playing happily as his parents and sister sang “Wheels on the Bus” with his twin brother. The next morning, Hayden’s dad couldn’t […]


Biomarker, Innovation

Geneseeq scores FDA breakthrough designation for cancer detection device

January 4, 2024

Via: Medical Device Network

The US Food and Drug Administration (FDA) has granted breakthrough device designation to CanScan, the multi-cancer early detection solution by Canadian medtech Geneseeq. CanScan was built using Geneseeq’s highly sensitive MERCURY multi-omics technology. The solution uses low-depth whole-genome sequencing (WGS) […]


Biomarker, Innovation

Daxor seeks US FDA approval for blood volume analyser 

January 3, 2024

Via: Medical Device Network

Daxor Corporation is seeking approval from the US Food and Drug Administration (FDA) for its next-generation blood volume analyser, Daxor BVA. Daxor BVA is designed for rapid, simple, and bedside patient care. The company submitted to the FDA through the […]


Innovation, Med Tech

FDA approves AnX Robotica’s AI endoscopy tool

January 3, 2024

Via: Medical Device Network

US-based manufacturing company AnX Robotica has received de novo clearance from the US Food and Drug Administration (FDA) for its artificial intelligence (AI)-assisted endoscopy tool NaviCam ProScan. NaviCam Proscan utilises a deep learning algorithm called convolutional neural networks (CNNs), which […]


Innovation, Patient Experience

Can Family Doctors Deliver Rural America From Its Maternal Health Crisis?

January 2, 2024

Via: Kaiser Health News

Zita Magloire carefully adjusted a soft measuring tape across Kenadie Evans’ pregnant belly. Determining a baby’s size during a 28-week obstetrical visit is routine. But Magloire, a family physician trained in obstetrics, knows that finding the mother’s uterus and, thus, […]


Innovation, Med Tech

AI Cybersecurity in Healthcare: Key Risks and Security Measures

December 29, 2023

Via: HitConsultant

Leaps in healthcare technology continue to benefit humankind: from the advent of the X-ray in the 19th century to dialysis, CT, MRI, and other machines in the 20th century, to a new breadth of digital tools in this era. Perhaps […]


Innovation, Patient Experience

Rethinking How We Treat Dually Diagnosed Patients

December 29, 2023

Via: HitConsultant

One of the most pressing and often overlooked challenges in healthcare today is how to reach and effectively treat dually diagnosed patients — commonly, individuals who grapple with both mental health problems and substance use issues. According to the Substance […]


Innovation, Medical Devices

Boston Scientific begins trial of persistent atrial fibrillation system

December 29, 2023

Via: Medical Device Network

Boston Scientific has commenced the AVANT GUARD clinical trial of the FARAPULSE Pulsed Field Ablation (PFA) System as a first-line treatment for persistent atrial fibrillation. The first trial subject was enrolled at the Cleveland Clinic in the US. AVANT GUARD […]


Biomarker, Innovation

Co-Dx seeks FDA emergency use authorization for Covid-19 test

December 28, 2023

Via: Medical Device Network

Molecular diagnostics company Co-Diagnostics (Co-Dx) has sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Co-Dx PCR Covid-19 test with Co-Dx PCR Pro instrument. Co-Dx’s submission for review by the FDA includes the PCR […]


Innovation, Patient Experience

4 Ways to Boost the Patient Experience Using Digital Check-ins

December 28, 2023

Via: HitConsultant

Finding a frustrated patient sitting in a waiting room has become familiar. Three and a half years after the pandemic’s start, the medical field is still feeling the ripple effects. Burnout and staffing shortages plague offices nationwide, causing tasks to […]


Innovation, Med Tech

Sofwave Medical secures FDA clearance for skin laxity improvement device

December 27, 2023

Via: Medical Device Network

The US Food and Drug Administration (FDA) has expanded clearance to Sofwave Medical’s technology to improve the appearance of skin laxity on the upper arm. The synchronous ultrasound parallel beam (SUPERB) technology delivers pulsed energy to collagen located in the […]


Innovation, Patient Experience

A data-led look at the booming remote patient monitoring market

December 22, 2023

Via: Medical Device Network

One of the most significant advances in healthcare has been the rise of remote patient monitoring (RPM) technologies. Its integration into routine care practices has the potential to not only improve patient outcomes but also revolutionise the entire healthcare landscape, […]


Innovation, Medical Devices

Deep Flaws in FDA Oversight of Medical Devices, and Patient Harm, Exposed in Lawsuits and Records

December 21, 2023

Via: Kaiser Health News

Living with diabetes, Carlton “PeeWee” Gautney Jr. relied on a digital device about the size of a deck of playing cards to pump insulin into his bloodstream. The pump, manufactured by device maker Medtronic, connected plastic tubing to an insulin […]


Innovation, Research

The Most Common COVID Symptoms Doctors Are Seeing This Holiday Season

December 20, 2023

Via: HuffPost

In unfortunate news, cases of COVID-19 are increasing just in time for the holidays. Behind this uptick is a new strain called JN.1, which accounted for 21.4% of cases in the United States as of Dec. 9, according to data […]


Innovation, Medical Devices

Neuronetics lands FDA clearance for TMS therapy accessory

December 18, 2023

Via: Medical Device Network

Neuronetics has received US Food and Drug Administration (FDA) clearance for its NeuroSite Coil placement accessory, a tool that helps users with accurate coil placement. US-based Neuronetics was the first company to receive FDA approval for its transcranial magnetic stimulation […]