Regulation

By Jonah Comstock 06:27 am December 1, 2015
This week the United States Supreme Court declined to hear a case about veterinary medicine delivered via email. In the case, a 69-year-old veterinarian named Ron Hines is suing the Texas State Board of Veterinary Medical Examiners over a Texas law that makes it illegal for veterinarians to give advice over the internet or telephone without first conducting a physical examination of the animal in...
By Brian Dolan 09:49 am November 24, 2015
Considering recent events, big name consumer brands are more likely than ever to move into regulated medical devices. Two weeks ago Apple CEO Tim Cook told a newspaper that while his company wouldn't put the Apple Watch through the motions of an FDA clearance process, Cook "wouldn't mind putting something adjacent to the watch through it." He said that before adding maybe that'd be an app or...
By Aditi Pai 10:15 am November 23, 2015
Philips has launched its smartphone- and tablet-connected ultrasound system for physicians, called Lumify, in the United States, just a few weeks after it was cleared by the FDA for prescription use. The system is available for a month-to-month subscription starting at $199. The system consists of the Lumify transducer, which connects to the app via USB connection; the companion app, available on...
By Jonah Comstock 09:49 am November 23, 2015
Michael Millenson There appears to be a broad consensus that patient-centeredness is important to the future of healthcare, according to a new report from the Urban Institute. But peeking under the surface of that apparent consensus reveals that the term means many things to many people, and that not all patient-centric initiatives are complementary. "While the umbrella term 'patient-centered...
By Jonah Comstock 08:50 am November 17, 2015
Visible Patient, a French company that makes 3D models of human organs to assist surgeons, has received FDA 510(k) clearance for its VP Planning Software Suite. The software suite has had a CE Mark for six months and has been commercially available in Europe for a year. Via the software, surgeons send radiological data like CT and MRI scans to Visible Patient. In-house designers create 3D models...
By Brian Dolan 10:06 am November 11, 2015
Before Apple revealed the Apple Watch, rumors circulated that because public records showed the company had met with FDA officials a few times, Apple was working on an advanced, sensor-laden wearable device with medical features that required FDA clearance. At the time, back in early 2014 I made the case that Apple was actually trying to ensure its wearable didn't trip a regulatory third rail and...
By Jonah Comstock 07:04 am November 11, 2015
When Kenneth Stack's son was diagnosed with Type 1 diabetes just before his fifth birthday, the doctor told Stack he was just a few years too early for a major medical breakthrough. "I remember, trying to make sense of all of this, the doctor saying 'In three years, we’ll have perfected the artificial pancreas and you won’t have to worry about this'," Stack recalled at a panel discussion at the...
By Aditi Pai 10:52 am November 10, 2015
The US Department of Veterans Affairs (VA) employs a few key principles to engage its population with mobile health tools, according to Dr. Neil Evans, co-director of the VA connected health department who spokes at the HIMSS Connected Health Conference this week. One of the principles the VA focuses on, though Evans admits it is a very basic one, is knowing its customer. "Our customer is the...
By Jonah Comstock 09:42 am November 4, 2015
Exco InTouch's mobile clinical trial software. The FDA wants to know more about mobile-enabled clinical trials for investigational drugs. According to a recent post on the Federal Register by Associate Commissioner for Policy Leslie Kux, the FDA is soliciting comments "from a broad group of stakeholders on the scope and direction of the use of technologies and innovative methods in the conduct...
By Aditi Pai 11:30 am November 3, 2015
San Diego, California-based Reflexion Health has received FDA 510(k) clearance for its digital physical therapy tool, called Vera, which uses Microsoft Kinect motion-tracking to help patients with musculoskeletal rehabilitation. “We are thrilled to be one of a growing number of digital medicine companies to receive FDA clearance to use innovative tools and methods, such as Vera, to deliver care...