How to design a successful embolic protection devices clinical trial

Embolic protection devices could reduce risks of interventional cardiac procedures such as TAVR, but their efficacy is hard to prove. David Novotny, Novella Clinical The embolic protection device (EPD) market is expected to grow into a billion-dollar industry if the device becomes the standard safety protocol for transcatheter aortic valve replacement (TAVR) and other interventional

Medtech stories we missed this week: Sept. 15, 2017

From Acera Surgical and Telos Medical’s partnership to Xtant Medical’s 510(k) clearance, here are seven medtech stories we missed this week but thought were still worth a mention. 1. Acera Surgical partners with Telos Medical for Restrata wound matrix trial Telos Partners announced in a Sept. 14 press release that Acera Surgical has chosen Telos to

Medtech stories we missed this week: September 8, 2017

From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating

Sirtex swings to a loss after ‘challenging’ year

Shares in Australian cancer treatment developer Sirtex Medical (ASX:SRX) plunged more than 15% yesterday after the company posted a net loss of -A$26.9 million in 2016, compared to a profit of A$54 million the year before. Sirtex has faced a barrage of obstacles this year, including a number of clinical trials that failed to meet primary endpoints.

Medtech stories we missed this week: August 11, 2017

From Xtant Medical’s 510(k) extension to Varian Medical’s distribution deal, here are seven medtech stories we missed this week but thought were still worth a mention. 1. FDA extends Xtant Medical’s 510(k) for Calix C spinal implant Xtant Medical announced in an Aug. 9 press release that the FDA has cleared its product line extensions

Medtech stories we missed this week: July 21, 2017

From Second Sight’s South Korean market entry to Sanuwave’s Indonesian distribution deal, here are medtech stories we missed this week but thought were still worth mentioning. 1. Second Sight enters South Korea market Second Sight announced in a July 5 press release that it has entered the market in South Korea with the implantation of two

Clinical evaluation reports and China: What you need to know

Grace Fu Palma, China Med Device China introduced new requirements for clinical evaluation reports in 2015. Understanding the China Food and Drug Administration’s new CER requirements can help companies to be better prepared in their CFDA submissions. 1. Summarizing data The CER must summarize the data from clinical literature, clinical experience, and clinical trials, etc.

Medtech stories we missed this week: July 14, 2017

From Novarad touting its VR-surgical guidance system to Zynex paying off its $2.2M loan, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Stimwave announces first patient in Brazil Stimwave announced in a July 5 press release that its first patients in Brazil have received Stimwave’s wireless pain relief

Medtech stories we missed this week: June 30, 2017

From ConforMIS touting its knee replacement study to Consulting Radiologists’s new breast cancer detection tool, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Study: Low-dose CT scanning improves Ankylosing Spondylitis assessment A new study has shown that low-dose computed tomography (LD-CT) is more sensitive than X-rays for monitoring

Researchers claim 100% cancer detection rate

Researchers at the University of Montreal Hospital Research Center say they have developed a multimodal optical spectroscopy probe that could provide better detection of common forms of cancer, enabling longer life expectancies and lower risk of recurrence. The team, which began work on the probe in 2015, have refined the invention and designed a new

Are we closer to a game-changing device for Parkinson’s disease?

University of Washington researchers say they’ve developed an advanced deep brain stimulation system to treat essential tremor and Parkinson’s without constantly being “on,” allowing for longer battery life and better treatment. The system utilizes electrodes on top of the brain to sense movement in parts of the body that experience essential tremor, alongside a deep

Pamplona Capital to acquire Parexel in $5B deal

Parexel said today that it would go private after Pamplona Capital agreed to buy the pharmaceutical research services company in a deal valued at $5 billion. Pamplona is slated to pay $88.10 per share for Parexel, which is a 5% premium to the stock’s close on Monday. Activist investors, such as Starboard Value, have been

Medtech stories we missed this week: June 9, 2017

From 3M’s expanded 510(k) clearance for its Tegaderm dressing to Medtronic and Acacia burying the hatchet, here are 7 medtech stories we missed this week but thought were still worth mentioning. 1. InspireMD inks Taiwanese distro deal for CGuard InspireMD announced in a June 8 press release that it has signed a distribution deal with

Amaranth Medical looks to recapture the potential of bioresorbable scaffolds

Dr. Antonio Colombo had finished his presentation of 9-month data for Amaranth Medical‘s Aptitude sirolimus-eluting bioresorbable scaffold when an audience member asked about adverse events. He told the EuroPCR attendee that they hadn’t seen any adverse events related to the device during the trial – and that’s unusual. Bioresorbable scaffolds, like Abbott‘s (NYSE:ABT) Absorb, have been

This wearable patch detects sleep apnea

A disposable diagnostic patch can detect all types of sleep apnea, according to new clinical trial results. The results showed that the SomnaPatch device had a clinical agreement between the patch and standard polysomnography of 87.4%, with 95% confidence interval of 81.4% to 91.9%, according to its maker Somnarus. SomnaPatch weighs less than 1 ounce