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 […]
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 […]
What you need to know to make connected medical devices
Bill Welch, Phillips-Medisize The estimated number of connected medical devices – devices connected to the Internet –is expected to increase from 10 billion to 50 billion over the next decade, according to the IBM Institute for Business Value. This is due to the ability for machine-to-machine communication through cloud computing and networks of data-gathering sensors, […]
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, […]
The top medtech stories of early 2017
The new Trump administration and Republican Congress – and all the accompanying change and uncertainty – is the major story for the medical device industry. But there are many other medtech stories worth noting from the first quarter of 2017. There was an FDA warning over Abbott’s Absorb bioresorbable stent, a continued spate of M&A deals, diabetes […]
Do patient advocacy organizations have a conflict of interest?
At least 83% of U.S. patient advocacy organizations receive financial support from medical device, drug and biotechnology companies, according to new research out of the University of Pennsylvania’s Department of Medical Ethics and Health Policy. The Penn research team – which included Matthew McCoy, Harald Schmidt and Ezekiel Emanuel – examined websites and annual reports for 104 organizations […]
3D printing is taking medical marijuana to a whole new level
3D printing is aiding an Israel-based company in the development and production of special selective-dose inhalers for medical marijuana and other medicinal plants. Nano Dimension (Ness Ziona, Israel)—which makes 3D printers for printed circuit boards—announced today that it has leased a DragonFly 2020 3D printer to Syqe Medical (Tel Aviv, Israel). Syqe boasts that it has created the […]
This new hydrogel can regrow bone in skulls
Researchers in Illinois say they were able to regrow bone to repair a hole in a mouse’s skull. The researchers, based at Northwestern University and the University of Chicago, think their work could lead to significant improvement in the care of people with severe skull or face trauma. They say they were able to regenerate skull bone […]
Orthofix’s foreign corruption woes: Here’s what you can learn
Marc Alain Bohn, Miller & Chevalier Orthofix International in January entered into its second Foreign Corrupt Practices Act (FCPA) settlement in less than 5 years, resolving allegations with the U.S. Securities and Exchange Commission that the company’s Brazilian subsidiary made improper payments to doctors at government-owned hospitals in Brazil to increase sales. Orthofix consented to the entry […]
E.U. publishes final version of medical device regulations
Ronald Boumans, Emergo Final versions of the European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) have been published, and will come to a formal vote by the European Council on March 7 and by the European Parliament on March 20. Following these votes, the MDR and IVDR are expected to be formally published in late […]
