Industry takes: the importance of keeping healthcare businesses cybersecure
A doctor checks up on their cybersecurity network. Photo: Andrew Angelov/Shutterstock. Cybersecurity is vital for all industries, but there are in which breaches have more impact than healthcare. Threats like patient data leaks and attacks affecting vital hospital machinery can have major impacts on patients’ lives. Due to confidentiality and liability clauses, they can also […]
UK NICE backs Exact’s Oncotype cancer genomic test
Exact Sciences’ Oncotype DX breast recurrence score test has an 85% sensitivity in identifying postmenopausal patients whose cancer outcomes are not likely improved by chemotherapy. Image Credit: JHVEPhoto / Shutterstock. The UK’s National Institute for Health and Care Excellence (Nice) has recommended the use of Exact Sciences’s genomic test Oncotype DX breast recurrence score test […]
Freyja wins FDA clearance for VereSee device
A laparoscopy is a type of surgery that lets a surgeon look inside the body without making a large incision. Credit: amab via Shutterstock. Early-stage medical device company Freyja Healthcare has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VereSee device, used in laparoscopic surgery. Laparoscopic surgery is a minimally […]
Field Medical begins ventricular PFA technology trial
The FieldForce Catheter is said to be the first and only contact force PFA catheter optimised for the ventricles. Credit: PRNewswire/ Field Medical, Inc. Field Medical has announced the commencement of first-in-human trials for its FieldForce pulsed field ablation (PFA) system at Na Homolce Hospital in Prague, Czech Republic. FieldForce, which is said to be […]
R3 Vascular secures funding to support bioresorbable scaffold trial
Christopher Owens has been named as new president and CEO of R3 Vascular. Credit: GlobeNewswire/R3 Vascular. Medical device company R3 Vascular has successfully closed an $87m Series B financing round led by affiliates of Deerfield Management, to support a trial of its bioresorbable scaffold, MAGNITUDE. The financing round saw participation from existing shareholders, including 415 […]
Neuralink’s first brain chip implant faces setback
The device’s functionality started to decline after some of the threads that connect the chip with the brain, began retracting. Credit: Aleksandra Sova/Shutterstock.com. Neuralink has reported an unexpected setback with its first chip implanted in a human skull, as the device began detaching from the patient’s brain. The incident involved Noland Arbaugh, who had the […]
UK MHRA pilots AI Airlock regulatory sandbox
The MHRA AI Airlock is designed to help the agency identify and address the challenges for regulating standalone AI medical devices. Credit: Shutterstock / raker. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched its artificial intelligence (AI) Airlock sandbox model designed to test virtual and real-world projects through simulation and help develop […]
OrthoXel’s Vertex Hip Fracture Nail system obtains US clearance
OrthoXel’s Vertex Hip Fracture Nail (HFN) system. Credit: PRNewswire/OrthoXel. OrthoXel has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Vertex Hip Fracture Nail (HFN), designed to improve hip fracture treatment. The Vertex HFN is designed to address common challenges faced in hip fracture management such as instability and high cutout […]
Infectious disease trends for CROs in 2024
CROs working within trials for infectious diseases face a number of challenges post-pandemic. Credit: Gorodenkoff via Shutterstock. The global healthcare sector has witnessed both unprecedented challenges and achievements over the past few years, most notably during the pursuit of the COVID-19 vaccine in 2020-21. The accelerated development of that vaccine not only achieved timeline speeds […]
Tandem’s insulin pump app glitch triggers FDA Class I recall
The Tandem app glitch applies to 85,863 devices and has resulted in 224 injuries, as of 15 April. Image Credit: JHVEPhoto / Shutterstock. The US Food and Drug Administration (FDA) has issued a Class I recall, the most serious designation for a medical device, for Tandem Diabetes Care’s t:connect mobile app used in conjunction with […]