What Is SaMD? A Quick Guide for Medical Device Startups and Investors
What is SaMD? Here’s why both medical device startups and investors should take a second look:
FDA 510(k) and Pathways to Market for New Medical Devices
Developing a new medical device? Determining your FDA pathway to market early can help to smooth your way. Here are three possible routes:
The Disadvantages of Technology in Healthcare
Technology permeates our lives more than ever, as technological advances continuously emerge. Every industry has been upended and transformed, including the health and medical industry. While any innovation may seem like progress, there are certainly both advantages and disadvantages of technology in healthcare. Surgeons today can perform feats that years ago
What a Colonial Pipeline Attack Teaches Us About Cybersecurity
The cyber attack on the Colonial Pipeline experienced heavy media coverage last month, and for good reason. The important pipeline system — largely used to carry gasoline and jet fuel throughout the southeastern USA — was hacked for a payout of 75 bitcoin, or roughly $5 million. And while that is certainly a large payment, […]
Case Study: Galen Data Accelerates Go-To-Market for Gastric Diagnostic Startup, Alimetry Ltd.
Alimetry Ltd., a New Zealand-based startup, recently announced the launch of their revolutionary diagnostic tool for gastrointestinal disorders. The company knew they wanted their device connected to a cloud (with an accompanying mobile app) to help explain to patients what was causing their symptoms, and to provide clinicians near-real-time data and user-frien
Medical Device Regulation
Are you equipped to meet medical device regulatory needs today, and adjust for the changes of tomorrow? FDA medical device regulation can be quite complex — and for good reason. There are many different laws, rules, and best practices that may affect your cloud-connected medical device today, and in the future. EU medical device regulation […]
12 Sleep Technology Medical Devices Revolutionizing Sleep
Are you getting enough sleep? If you’re like the majority of the population, the answer is: probably not. Not getting enough sleep can impact your physical and mental health, causing things like workplace injuries, decreased memory, increased irritability, and even symptoms of depression. In fact, sleep deprivation is linked to 7 out of the 15 […]
Somnera™ gets FDA Clearance with the Help of Galen Data
Somnera (formerly Fresca Medical) is a medical device company with a focus on sleep devices. The company developed an innovative low-flow positive airway pressure system for patients with obstructive sleep apnea. Working with a tight timeline, Somnera enlisted the help of Galen Data to achieve device-to-cloud connectivity in a fraction of the time (had they [&h
9 Medical Device Startups that Investors Love in 2021
Venture capital investments are the lifeblood of many successful technology startups, and medical device companies are no different. In fact, medical device companies often require more early-stage capital due to the capital-intensive nature of manufacturing a device and the clinical and regulatory requirements. With the much-needed capital and expertise these
California SB-327: The Security of Connected Devices
What California’s iOT Security Law Means for Medical Devices In September 2018, California’s governor signed Senate Bill 327, the Security of Connected Devices, into law, which went into effect on January 1, 2020. Its purpose was to extend already existing privacy laws to connected devices and the information they collect, store and transmit. Unlike the
