Gynesonics announced that it has submitted its 510(k) Premarket Notification to the FDA for its Sonata System. The Sonata System is a uterus preserving, incision-free uterine fibroid treatment that was designed to treat fibroids transcervically with radiofrequency energy. “Submission of the 510(k) application is an important milestone for our company,” Chris Owens, president and CEO […]
7 medical devices combating the opioid crisis
Opioid-related deaths have become an epidemic in the U.S., garnering attention from the White House, the FDA and many other governmental bodies. From 2000 to 2014, nearly half a million Americans died from drug overdoses. In 2015, more than 50,000 people died from drug overdoses, and 33,000 were opioid-related. Prescription overdoses continue to cause more […]
European Union IoT cybersecurity recommendations for medical devices
By Stewart Eisenhart, Emergo Group A new set of critical infrastructure security recommendations from European regulators targets the Internet of Things (IoT), with significant implications for medical device manufacturers and health technology developers’ cybersecurity risk mitigation efforts ahead of a major data protection compliance deadline in 2018. Get the full story here at the Emergo […]
Effective design considerations for medical device warning labels
By Michael Wiklund, Emergo Group Some people believe that warnings are useless; printed on medical devices only to offer legal protection. Indeed, manufacturers can and have been held liable for the “failure to warn,” and adding warnings neutralizes this claim. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
New FDA guidance for dual submission 510(k) and CLIA waiver application for IVD companies
By Stewart Eisenhart, Emergo Group New guidance from the US Food and Drug Administration explains requirements for in vitro diagnostic manufacturers to register for premarket notification using the agency’s Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application. Get the full story here at the Emergo Group’s blog. The opinions expressed in this […]
FDA suggests controls on interoperable devices
The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations […]
7 medtech stories we missed this week: Dec. 8, 2017
From Minimus Spine’s European distribution deal to Stimwave receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Minimus Spine inks EU distribution deal Minimus Spine announced in a Dec. 4 press release that it has signed its first European distribution deal with Italian company Moss […]
Sterifre Medical raises nearly $5 million for desktop sterilization device
Sterifre Medical, a company that has developed a desktop sterilization device that only uses room temperature plasma, has raised nearly $5 million in its present funding round, according to a recent U.S. Securities and Exchange Commission filing. The company has raised $4,827,500 toward its present $12 million goal, according to a Form D filed with […]
FDA releases Breakthrough Devices Program draft guidance
On Dec. 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating […]
10 companies to check out at BIOMEDevice San Jose
BIOMEDevice San Jose is an opportunity for thousands of medtech engineers and executives to come together and network. The annual event, created by UBM, is an industry showcase that allows various medtech manufacturers and suppliers to tout their expertise. This year’s event takes place at the San Jose Convention Center in San Jose, Calif., Dec. 6 […]
New harmonized standards for medical devices, IVD in Europe
By Stewart Eisenhart, Emergo Group The European Commission has issued updated lists of harmonized standards for medical devices and in-vitro diagnostic (IVD) products in the Official Journal of the European Union (OJEU). Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do […]