Patient engagement is increasingly the order of the day in the device development process as the U.S. FDA has made clear, a consideration that drove the Oct. 22 FDA advisory hearing. A patient representative said patients want to take part as early as possible in the development process for software as a medical device (SaMD), and Pat Baird, director of global software standards for Royal Pillips NV, said industry is very much open to ideas about bringing the patient perspective on board earlier in that process.
Royal Philips NV is launching its Quickclear mechanical thrombectomy system in the U.S. four months after obtaining FDA clearance. “Quickclear's intuitive design simplifies the entire thrombectomy procedure work flow. Our new medical device can help bring cost-effective solutions in both the hospital and outpatient care settings,” Chris Landon, senior vice president & business leader, image guided therapy devices at Philips, told BioWorld.
Royal Philips NV reported a 6% decline in year-to-year sales for the second quarter of 2020. While delays in elective procedures suppressed sales in the Amsterdam-based company’s diagnostics and treatment division, the virus boosted demand for connected care and minimized the impact of the coronavirus for the company compared to many competitors.
Biointellisense Inc. received an FDA clearance in January for its Biosticker to monitor patient vital signs at home for as long as 30 days. It was just starting to launch, when along came the novel coronavirus. Now, the Band-Aid-sized monitor is being used to monitor COVID-19 patients at home, as well as chronic disease patients.
A wireless system to monitor mothers in labor and their fetuses has been introduced by Royal Philips NV in the U.S. Known as the Avalon CL Fetal and Maternal Pod and Patch, it is commercialized under recently updated guidance from the U.S. FDA. The Amsterdam-based company is continuing to pursue a standard 510(k) clearance for the system, which is marketed in European countries, Australia, New Zealand and Singapore.
Amsterdam-based Royal Philips NV has launched a five-day, wearable biosensor patch that monitors respiratory and heart rates once every minute, as well as assesses contextual information such as posture, activity level and ambulation. The wearable, disposable patch, dubbed the Philips Biosensor BX100, has received FDA clearance and a CE mark and is intended for use in lower acuity hospital care.
As COVID-19 testing remains elusive in the U.S., much of the nation’s focus has started to shift to how to treat the presumed millions of patients who are already or soon to be infected with the novel coronavirus.
HONG KONG – Neurophet Inc., a South Korean AI-based brain disease diagnostics company, has secured ₩6 billion (US$5.1 million) in series A funding. The med-tech startup produces solutions based on Segengine, the company’s own technology that automatically segments brain magnetic resonance (MR) images into 107 regions within a minute.
A neuropsychologist consult is typically the first step for a neurologist in aiding in the diagnosis and monitoring of neurological conditions. But timely appointments for an assessment by these specialists can be difficult to obtain, even under the best of circumstances. To better enable neurologists to assess which patients are most in need of a consultation with a neuropsychologist, Royal Philips NV has launched an artificial intelligence (AI)-based cognitive assessment tool in the U.S. Known as Philips Intellispace Cognition, the digital, cloud-based assessment tool takes established neuropsychological tests and enables their administration by a medical assistant via a tablet in an office setting.
Diagnosis and treatment of infections typically occurs after people exhibit obvious signs of illness, such as fever or a cough. By then, they may already have exposed others and are well on the way to developing more serious symptoms themselves. In the military, such delays can hamper medical countermeasures to contain potential outbreaks and reduce downtime among active duty personnel. Now, Amsterdam-based Royal Philips NV and the U.S. Department of Defense's Defense Threat Reduction Agency and Defense Innovations Unit have built an early warning algorithm – using artificial intelligence – to detect infection before a person shows any signs or symptoms of infection.
