The opioid epidemic is one of the deadliest problems facing the U.S. today. Through the development of new pain management devices, medtech could be a leader in solving the crisis. The prescription opioid overdose crisis in America didn’t start until the late 1990s, when pharmaceutical companies touted prescription painkillers that weren’t supposed to be addictive. […]
CES 2018: Medical technologies you need to know
Mobile health devices and wearables have increasingly played a prominent role at the annual CES show in Las Vegas. Health and medical devices touted at CES 2018 seek to improve everything from heart health to posture. Here are nine companies exhibiting digital health solutions at this year’s show. Next >>
Malaysian regulators extend moratorium to summer 2018 for qualifying medical device registrants
By Stewart Eisenhart, Emergo Group The Medical Device Authority (MDA), Malaysia’s medical device regulator, will extend a moratorium for companies that have registered for market access but not yet received approval so that they may continue selling in the country as their premarket reviews proceed. Get the full story here at the Emergo Group’s blog. […]
Stroke treatment: There’s a simple way to improve it in the U.S.
Technology is already available to greatly improve outcomes for people suffering from strokes, but the present healthcare system is standing in the way of people getting it, according to Stacey Pugh, VP and general manager of the neurovascular unit at Medtronic. The most important thing that could boost stroke treatment is passing proper legislation about […]
These lab-grown blood vessel replacements could benefit dialysis patients
University of Minnesota researchers have developed a blood vessel replacement made of biological materials in a lab. The lab-grown vessels have no living cells at implantation and could be used as a graft for kidney dialysis patients. The lab-engineered blood vessel replacement is the first nonsynthetic, decellularized graft that is repopulated with cells using the […]
Medical Device Excise Tax set to return early this year
By Stewart Eisenhart, Emergo Group Despite multi-year efforts to fully repeal the Medical Device Excise Tax (MDET) on device sales in the US, the tax appears set to come back into force in early 2018. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s […]
FDA refines least burdensome guidance for medical device oversight
By Stewart Eisenhart, Emergo Group Medical device regulators at the Food and Drug Administration have updated guidance clarifying what Least Burdensome Provisions mean for US market registrants. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of […]
This test can detect when your body is fighting a virus
A test that measures the RNA or protein molecules in human cells is also able to detect when your body is fighting a viral infection from respiratory symptoms, according to Yale researchers. The test involves a nasal swab and could be a faster and cheaper way to diagnose respiratory viral illnesses. “It’s a simpler test […]
5 medtech stories we missed this week: Dec. 29, 2017
From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning. 1. NanoVibronix inks deal with Indian regulatory and distribution consultant NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory […]
FDA clears device that treats diabetic foot ulcers for market
The FDA announced today that it has cleared the Dermapace System diabetic foot ulcer treatment device for market. Dermapace System, created by Sanuwave, is the first shockwave device to treat foot ulcers caused by diabetes. “Diabetes is the leading cause of lower limb amputations,” Binita Ashar, director of the division of surgical devices in FDA’s […]
How smartphones can remotely monitor chemotherapy patients
University of Pittsburgh research has recently shown that smartphone sensors coupled with a specifically-developed algorithm could detect worsening symptoms in chemotherapy patients. The sensors offer a way for cancer patients to be remotely monitored. The sensors and algorithm can detect objective changes in patient behavior to determine if symptoms are getting worse. Indications of worsening […]