Walt Maclay will be presenting on "Sensors and wearable devices for home health" on Friday, April 27, 2018. It looks like an amazing program and an extraordinary conference! We hope to see you there. https://www.smarthealth.tech/speaker/walter-maclaypresident-and-founder/
Voler developed the next generation clinical lice treatment unit that improved the usability and aesthetics, increased functionality, decreased costs, and improved portability. We provided very tight temperature control: hot enough to kill lice, not so hot it burns a child's head. Voler also added a cellular modem to enable tracking of each use (for reimbursement [...]
We are excited to be mentor at Stanford University's Health Hackathan. We will assess their technical feasibility and help provide guidance on product development.
Many mobile applications use sensors to monitor various activities- movement, sound, temperature, and the like. The sensors, if "always on" in full power would shorten battery life. Recent chip developments enable applications and devices to operate in a low power mode until they detect the signal that wakes them up and activates them for the [...]
image source: Human Factors and Medical Devices on FDA website by Walt Maclay Recently, I attended a fascinating panel discussion that explored the increasing importance of understanding human factors and user experience in the design and successful use of a medical device for home care or self-care. Medical devices like insulin pumps and home dialysis [...]
Wearable medical devices are biosensors attached to the human body to detect and monitor changes and capture biological / physiological data. These devices are usually non-invasive devices that function autonomously. Monitoring older adults and subjects with chronic conditions in the home and community are a growing focus of these applications. Common types of physiological functions [...]
by Walt Maclay At the 10x Medical Device Conference, which was held in San Diego the first week of May, I learned that major changes have been made in CE requirements for medical devices. After a long delay, the new rules were finally adopted in April of this year. The requirements are becoming more stringent, [...]
In a recent medical device project, we designed the control software and wrote the verification protocol for a class III heart pump. Our client submitted to the FDA and we are very happy to say that it was approved without any conditions or comments. It was quite unusual that the FDA had no comments on [...]