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 […]
medtech
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 […]
Medtech stories we missed this week: April 14, 2017
From FDA approvals to business expansion plans, here are medtech stories we missed this week but thought were still worth mentioning. 1. BioTelemetry launches offer to acquire LifeWatch BioTelemetry and LifeWatch announced in an April 9 press release that the 2 companies have entered a transaction agreement that states BioTelemetry will launch a tender offer to acquire all […]
How Boston Sci is getting drug-eluting stents and balloons into legs
Boston Scientific officials think they have a leg up when it comes to bringing drug-eluting technology to bear on peripheral artery disease. That’s because the medical device giant has decades of experience with balloons and drug-eluting stents used around the heart. When it comes to treating the narrowing arteries in the legs and thighs, Boston […]
Medtech stories we missed this week: April 7, 2017
New studies for umbilical cord allografts and tumor targeting were published this week while another company received European CE Marking. Here are some medtech stories we missed this week but thought were still worth mentioning. 1. AMNIOX touts new umbilical cord study AMNIOX Medical announced that it has published the results of 3 studies that demonstrate […]
How the CellMist SkinGun heals: a Q&A with RenovaCare’s CEO
Heather Thompson, Senior Editor When Thomas Bold joined RenovaCare in 2013, he was already familiar with its potentially groundbreaking technology. Bold had served as StemCell Systems CEO in Berlin for many years. He was involved in the development of the CellMist and SkinGun – the platform technologies for RenovaCare Inc. The technologies represent a shift in thinking about wound care, […]
This contact lenses breakthrough could enable glucose monitoring
Biosensing contact lenses may not be able to self-heal like “The Terminator,” but they could measure blood glucose and detect other signs of disease in the future. Oregon State University researchers are set to present a study that suggests transparent biosensors that are embedded into contact lenses could provide insight for doctors and patients without […]
Medtech stories we missed this week: March 31, 2017
This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press release that robot-assisted […]
Skin sensors provide insights into how to treat Parkinson’s
A University of Rochester research team is using wearable sensors to indicate the best individualized treatment of Parkinson’s disease. Bernadette Mroz suffers from Parkinson’s. When her medication isn’t working, it makes it hard for her to function. “My world goes into a spin cycle. I cannot function mentally, emotionally or physically,” said Mroz in a […]
