From FDA and Health Canada approvals to joint ventures, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device […]
MedTech
12 interesting wearables you should know
Wearable technology is probably one of those things you probably didn’t need but still wanted because people were always talking about the devices. Fitbit, Apple and Garmin are some of the main providers of health and wellness wearables. Each of them touts being able to track your fitness activity or measures your heart rate. However, consumer […]
Light-propelled water could create better microfluidic devices
Light-propelled water could enable microfluidic diagnostic devices with channels and valves that can be reprogrammed quickly, according to Massachusetts Institute of Technology researchers. The system was originally designed to help find a way to separate water and oil to treat the mixture of briny water and crude oil in oil wells. When droplets are small […]
How medtech companies can benefit from agile marketing
Getting a medical device to market can be tough. It has to go through several hoops at the FDA, including the 5-step premarket requirements that include: classifying the device; choosing the correct premarket submission; preparing appropriate information for premarket FDA submission; sending a premarket submission to the FDA and communicating with FDA staff during review; and […]
6 ways hydrogels are enabling medtech innovation
Hydrogels are water-based biomaterials developed specifically for human use, according to a Biomaterials journal article. They are a water-swollen polymeric material that doesn’t change its distinct 3D structure. They are formed from super-absorbent, chain-like polymers and are not soluble in water. However, their porous surface allows for nutrients and cell waste to pass through. They have shown the […]
23andMe is back: FDA allows marketing of genetic health risk tests
FDA this month allowed genetic testing company 23andMe to market genetic health risk tests for 10 diseases and conditions including Parkinson’s disease and late-onset Alzheimer’s disease. The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of […]
Philips wins FDA authorization for digitized biopsied tissue slides
Philips recently received FDA permission to market its Philips IntelliSite Pathology Solution (PIPS) – touted as the first whole slide imaging system over which pathologists can review digital versions slides prepared from biopsied tissue. The FDA permission, which the agency announced April 12, marks the first time the agency has allowed the marketing of a […]
Why ‘do no harm’ matters more than ever
A recent Retro Report in The New York Times looked back at the tragic history of lobotomies to remind viewers of the importance of the medical ethics principle, “First, do no harm,” and how it applies to the development of medical technologies for the brain today. The media positively covered lobotomies as a groundbreaking procedure able to cure mental […]
3D printed babies could help train surgeons: Here’s how
An Eindhoven University of Technology Ph.D. candidate is using 3D printing to create realistic models of baby skeletons and other organs to help train surgeons. Mark Thielen created an infant mannequin prototype that had realistic bones and organs. The model had a 3D printed heart with functioning valves and lungs that could breath like real […]
What does FDA really mean when something is 510(k) exempt?
FDA undoubtedly provided some good news to the medical device industry last month when it proposed exempting hundreds of moderate-risk devices from 510(k) requirements. But don’t break out the champagne just yet if you happen to be developing a device that appears to be on the list. Even when the agency says a particular generic […]
3 enduring leadership lessons to boost your medtech success
Brian Johnson, Publisher This one is for the caffeine-addled world-changers out there, who consume leadership memes on Linkedin for breakfast, searching for inspiration with the same passion as a bigfoot truther. For the past 6 years, I’ve interviewed the most successful men and women in the medical device industry at DeviceTalks, a conference I founded […]