Calif.-based DyAnsys, a medical device company specializing in the autonomous nervous system, announced Primary Relief, its percutaneous electrical nerve stimulator (PENS) system, received approval by the FDA to treat postoperative pain following cardiac surgery.
According to DyAnsys, the PENS system can be used for up to three days following cardiac surgery and, in a clinical trial, reduced...
Inito has announced the launch of its at-home fertility test in the US, months after receiving US FDA approval.
WHAT IT'S FOR
The company claims that Inito is the only ovulation test that measures estrogen and luteinising hormone levels to predict fertile days, as well as progesterone to confirm if ovulation has actually occurred.
The device can also be paired with a smartphone app to provide...
Sydney-based Omniscient Neurotechnology has received the US FDA's 510(k) clearance for its brain mapping software.
WHAT IT'S ABOUT
Quicktome is a digital brain mapping platform that provides clinicians with a visualisation of a patient's brain networks which are responsible for complex functions such as language, movement and cognition.
Featuring intuitive browser interfaces, the platform...
Brainstorming, smart design, and clinical validation are all vital steps toward the deployment of any new health technology, but without regulatory approval many of the most groundbreaking innovations will never have a chance to make an impact on patients and consumers.
In the US, these processes could see some shakeup in the future — FDA Commissioner Dr. Scott Gottlieb has been consistently...
04:20 pm
February 15, 2018
Food and Drug Administration Commissioner Dr. Scott Gottlieb released the agency’s budget requests for fiscal 2018 Tuesday, outlining digital health plans for the year.
The budget proposed by the Trump Administration would give the FDA $5.8 billion, an increase of $673 million, and would include an additional $190 million for new user fee funding.
The requested budget would support the FDA’s...
London-based medical device manufacturer LivaNova has announced FDA approval of its most recent Vagus Nerve Stimulation Therapy (VNS Therapy) System, which will be the smallest and lightest responsive therapy available for drug-resistant epilepsy patients aged four years and older.
The treatment consists of the new SenTiva implantable generator, the VNS Therapy Programming System, a wireless wand...
Israel-based LabStyle Innovations announced CE mark certification for its smartphone-based glucose monitor Dario, according to a press release. In the coming months, the company will plan a soft launch of Dario in Europe to collect customer feedback and refine its roll-out strategy.
In May, LabStyle raised $10 million by common stock and planned to use the money to develop, market and manufacture...
