Regulation

CREDIT: Bahrain News Agency

By  Ahmed El Sherif 04:29 am August 21, 2020
Bahrain’s National Health Regulatory Authority (NHRA) has announced plans to establish a track and trace electronic system to monitor the supply chain of medicines in the Kingdom. This new system will reportedly cover the entire process, from factory of origin to final patient.  The NHRA stated that the platform was to ensure that medicines – including controlled substances – are dispensed...
By  Dave Muoio 03:03 pm August 18, 2020
23andMe announced this morning that it has received a 510(k) clearance from the FDA that allows its direct-to-consumer personal pharmacogenetics report to guide use of two treatments without the need for confirmatory testing. WHAT HAPPENED This action updates a De Novo approval granted to the consumer genomics company in late 2018. That decision allowed 23andMe to market a test for one of 33...

Credit: ORCHA, Sigma 

By  Sara Mageit 06:49 am August 12, 2020
UK-based UX design and development agency, Sigma, has been selected by health app evaluation and advisor organisation, ORCHA, to improve usability and accessibility of their health apps. ORCHA provides review, accreditation services, reports and advice to developers, detailing what can be done to better meet the needs of health and care providers, including connecting them with specialists in the...
By  Dave Muoio 02:15 pm July 27, 2020
On Friday evening, the FDA reissued an emergency use authorization (EUA) for LabCorp's COVID-19 RE-PCR Test that now allows for testing among those without any symptoms of COVID-19. The agency also expanded the indication to allow for pooled sample testing – a technique of combining multiple samples into a single test, and then following up with individual tests should the group be positive. The...
By  Dave Muoio 02:56 pm July 24, 2020
Abbott has received FDA approval for a neuromodulation system-controller app that runs on iOS devices, the company announced Thursday. Compatible with Abbott's broader NeuroSphere Digital Care platform, the Patient Controller app replaces the separate device patients use to adjust the company's neuromodulation products. These include the Infinity DBS System for Parkinson's disease or essential...
By  Andrey Ostrovsky, MD 11:04 am July 20, 2020
About the author: Dr. Andrey Ostrovsky is the former chief medical officer of the U.S. Medicaid program. He is now the managing partner at Social Innovation Ventures where he invests in and advises companies and nonprofits dedicated to eliminating disparities. (See his relevant portfolio investments here.) He is also a practicing pediatrician. The COVID-19-induced state of Public Health Emergency...
By  Mallory Hackett 03:22 pm July 16, 2020
Today the remote and continuous-monitoring platform Vitls announced that it has received 510(k) clearance from the FDA. The Vitls Platform uses a single wearable device called Tégo that records vital signs. The device itself is wireless and waterproof, and it has a battery life up to 6 days. It records body temperature, pulse, heart rate variability, respiration rate, oxygen saturation, sleep and...
By  Mallory Hackett 02:15 pm July 7, 2020
RapidAI, a health tech company specializing in stroke imaging, has received clearance from the FDA for its Rapid ASPECTS neuroimaging analysis device. The product was designed to improve physicians’ interpretations of Non-Contrast CT (NCCT) scans using the automated ASPECT score, according to the company. It uses the Alberta Stroke Program Early CT Scoring (ASPECTS) and machine learning to come...
By  Mallory Hackett 09:18 am July 7, 2020
Cochlear Limited announced yesterday the U.S. Food and Drug Administration clearance of three new products to be added to the company’s suite of hearing technology devices, all of which can connect to smartphones. The Premarket Approval clearances went to the Kanso 2 Sound Processor, the Nucleus 7 Sound Processor for Nucleus 22 Implant recipients and the Custom Sound Pro fitting software. The new...
By  Laura Lovett 01:08 pm July 6, 2020
Abbott’s Bluetooth connected cardioverter defibrillator and cardiac resynchronization therapy defibrillator, part of the Gallant product line, scored FDA clearance this morning. Patients using the technology can connect it to a smartphone app, called MyMerlinPulse, which will let both patients and providers see transmission history and device performance. The app is also designed to nudge...