Silicone breast-implant makers Polytech Health & Aesthetics and G&G Biotechnology are getting together in a stock-swap merger. G&G designed the world’s first lightweight breast implant, the B-Lite, to reduce the impact of gravity on the reconstructed or augmented breast using technology developed by NASA to make its implants up to 30% lighter. The company sells its products in
Medtech stories we missed this week: July 6, 2018
July 6, 2018 By Leave a Comment
From Zetta getting FDA clearance to Prescient Medical receiving CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. Zetta wins FDA clearance for Zoom MRI software Zetta announced in a June 25 press release that its MRI software has received FDA 510(k) clearance. The software, known as
How’d they do that? 7 innovations from medical device contract manufacturers
June 29, 2018 By Leave a Comment
Charles Darwin wrote, “In the long history of humankind (and animal kind, too) those who learned to collaborate and improvise most effectively have prevailed.” Medical device companies get the credit for many innovations, but many need the ingenuity and commitment of contract manufacturers who design and produce the components that make those big splashes possible.
This wireless system powers devices inside the body
June 21, 2018 By Leave a Comment
Massachusetts Institute of Technology researchers and Brigham and Women’s Hospital scientists have developed a wireless, ingestible system that can power and communicate with devices that are implanted deep within the body. The researchers suggest that the system could be used to deliver drugs, monitor conditions inside the body or treat diseases by stimulating the brain
SetPoint Medical touts 2-year relief from rheumatoid arthritis
June 19, 2018 By Leave a Comment
Startup SetPoint Medical has demonstrated “significant, sustained improvement” over two years in a first-in-human study using bioelectronic therapy in patients with rheumatoid arthritis (RA). Seventeen subjects with moderate to severe symptoms were implanted with a vagus nerve stimulator in the European study. At three months, the therapy was shown to have significantly reduced RA symptoms
LiveNova wins FDA clearance for mitral annuloplasty ring
June 15, 2018 By Leave a Comment
LivaNova recently announced that it has received FDA 510(k) clearance for its Memo 4D semi-rigid mitral annuloplasty ring. Memo 4D is the next generation of devices in the company’s Memo device family. It comes in a wide range of ring sizes from 24 to 42mm, allowing for more patients with mitral regurgitation to get treatment.
Medtech stories we missed this week: June 15, 2018
June 15, 2018 By Leave a Comment
From Cytosorbents opening a new U.S. manufacturing facility to DyAnsys received FDA clearance for a wearable to treat opioid withdrawals, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Cytosorbents opens new U.S. manufacturing facility CytoSorbents announced in a June 12 press release that it has opened a new
Medtech stories we missed this week: May 25, 2018
May 25, 2018 By Leave a Comment
From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press releasethat it has received FDA 510(k) clearance for
The best medtech funding option you’ve never heard of
May 4, 2018 By Leave a Comment
Regulation A+ (Reg A+) is a funding option that feels tailor-made for high impact technologies like medtech. Never heard of it? That’s because it didn’t exist until 2015, when the Obama administration passed the JOBS Act. Before then, private companies could only seek backing from the wealthiest 2% of Americans — accredited investors. The new
Medtech stories we missed this week: April 27, 2018
April 27, 2018 By Leave a Comment
From DuPuy Synthes’s spinal implant launch to Lumendi’s FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. DePuy Synthes launches spinal implants DePuy Synthes announced in an April 26 press release that it has launched its Proti 360º integrated titanium family of interbody devices that are designed
What is a left ventricular assist device and how does it work?
April 23, 2018 By Leave a Comment
What is a left ventricular assist device? A left ventricle assist device (LVAD) is a mechanical pump that attaches to the left ventricle of the heart to supplement the function of the pumping chamber, according to Jodi Hutchins, a regulatory and quality consultant at Proven Process Medical Devices. The left ventricle of the heart is responsible
Medtech stories we missed this week: April 20, 2018
April 20, 2018 By Leave a Comment
From CHF Solutions’ new Italian distribution deal to Masimo’s CE Mark approval, here are five medtech stories we missed this week but thought were still worth mentioning. 1. CHF Solutions signs Italian distribution deal CHF Solutions announced in an April 17 press release that it has signed a new distribution agreement with TRX Italy to distribute
Turns out graphene can fight bacteria on implants
April 18, 2018 By Leave a Comment
Graphene flakes that are arranged like spikes can kill bacteria and stop infections during implant surgery procedures, according to new research from Chalmers University of Technology in Göteborg, Sweden. Bacteria moves around the body in fluids like blood looking for an area to stick to. Once they find a place, the bacteria starts to grow
ACell launches Gentrix Incisional for surgical site reinforcement
April 12, 2018 By Leave a Comment
ACell recently announced that it has launched its Gentrix Incisional implantable device that is designed to reinforce soft tissue in surgical site incisions. Gentrix Incisional uses ACell’s MatriStem UBM technology to reinforce soft tissues. It is an extracellular matrix that helps remodel site-appropriate functional tissue where scarring normally occurs. Gentrix Incisional creates a scaffold for
Medtech stories we missed this week: April 6, 2018
April 6, 2018 By Leave a Comment
From CHF Solutions’s distribution deal to Guided Therapeutics’s licensing agreement, here are seven medtech stories we missed this week but throught were still worth mentioning. 1. CHF inks Spanish distribution deal CHF Solutions announced in an April 5 press release that it has signed a distribution agreement with Dimedix Surgical. The distribution agreement will allow
