Tag: technology

February 5, 2024

Aclinical investigation may not be mandatory for Implantable and Class III medical devices under Article 61(4)-(6) of the European Union Medical Device Regulation (EU MDR) if one of four cases apply to the device under evaluation, said John Thomas, director […]

February 1, 2024

The FDA believes the healthcare sector is yet to realize the full potential of DHTs in the detection of diabetes, “especially in diverse populations, particularly racial and ethnic minorities.” The agency sees the technologies as an enabler of the focus […]

January 29, 2024

The future of healthcare and improved patient outcomes relies on a competent workforce and a prepared talent pipeline. Three in four employers cite challenges in hiring, and the healthcare industry is most impacted by the talent shortage. Providing high-quality healthcare […]

January 25, 2024

Healthcare leaders should champion human-AI collaboration by having people work with AI to validate insights and develop engagement strategies. Organizations can — and should — implement conversational AI because it allows leaders to identify actionable areas of change and protects […]

January 24, 2024

Siemens Healthineers has received US Food and Drug Administration (FDA) approval for syngo Virtual Cockpit, a software that facilitates real-time remote scanning and collaboration among healthcare professionals. The multi-vendor scanning software allows radiologic technologists to connect with various scanners including […]

January 22, 2024

Breast cancer screenings can save lives through earlier detection. Mammograms are among the most common tests, although MRI scans and ultrasounds are other possibilities. Numerous studies show artificial intelligence (AI) could improve outcomes in various ways. Such results enable health […]

January 19, 2024

Medical device company Calcivis is set to launch its new preventive bioluminescent dental imaging system in the US. The move comes after the company secured final-stage US Food and Drug Administration (FDA) pre-market approval (PMA) for its new ergonomic, wireless, […]

January 18, 2024

Challenges await the healthcare industry, which is still recovering nearly four years after the COVID-19 pandemic began. Insurers and hospitals face rising costs while digital health companies struggle to strategize after years-low levels of investment. In Washington, federal regulators may […]

January 16, 2024

Harvard Pilgrim Health Care Institute Appoints New President Point32Health, the parent company of Harvard Pilgrim Health Care and Tufts Health Plan, announced that Emily Oken, MD, MPH, has been appointed the new president of the Harvard Pilgrim Health Care Institute, […]

January 12, 2024

Large technology firms like Microsoft, Google, Oracle and Amazon have invested heavily in generative AI over the past year. Many firms have honed in on using the tools, which can create original text and images, to lessen administrative burden for […]

January 11, 2024

Speed is of the essence for new medical devices entering the market – and the coating plays a vital role. Delays in the commercial launch of a medical device can have a serious impact on the bottom line and impede […]

January 11, 2024

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 […]

January 10, 2024

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 […]

January 9, 2024

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 […]

January 9, 2024

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 […]

January 4, 2024

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) […]

January 3, 2024

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 […]

December 29, 2023

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 […]

December 29, 2023

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 […]

December 29, 2023

From broken bones to torn muscles, orthopedic surgeons have seen it all. Oftentimes, a seemingly harmless habit or neglecting your bone health can lead to bodily harm. “The decisions you make now can prevent injuries from happening in the future,” […]