Physio-Control said today it inked a deal with Aircraft Medical to distribute its McGrath MAC EMS video laryngoscope internationally. U.K.-based Aircraft Medical’s laryngoscope is a traditional macintosh design, with the addition of video, providing both direct and indirect laryngeal views, the company said. “The most common feedback on the product is its ease of use, […]
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MRI-powered millirobots for minimally invasive surgery
By Nancy Fliesler MRI is a staple of surgical imaging, but it has the potential to do much more than take pictures. In 2011, bioengineer Pierre Dupont, PhD, and colleagues demonstrated that an MRI machine’s magnetic field could power a motor strong enough to control a robotic instrument, in this case driving a needle into an organ […]
Treating epilepsy is harder than you think
One minute, I was walking across the cafeteria floor at a highway stop restaurant. Without warning, everything suddenly faded to black. The next thing I remember: Coming to face-up on the floor with an intense headache, a pool of blood forming around my head. My husband, a small crowd, and a concerned nurse traveling with […]
Clarification: When COFEPRIS will accept ISO 13485 in lieu of EIRs for US devices seeking expedited Mexico registration
By Stewart Eisenhart, Emergo Group Emergo consultants in Mexico City have learned additional information regarding COFEPRIS requirements for US FDA-cleared or approved devices undergoing expedited registration in Mexico.
An innovative new breed of health care therapy is part device, part drug
By Matt Stupfel Health-care technology companies have long been easily categorized. There were device makers and there were drug makers. But those lines are being obscured by a kind of business that’s not quite a device maker and not quite a pharma company. Born out of rising competitive forces that reward innovation and threaten the […]
FDAVoice: Celebrating the 3rd anniversary of the FDA Safety and Innovation Act
By Stephen Ostroff, M.D. Anniversaries are celebrated for many different reasons. Sometimes it is to recognize the enduring strength of an institution. Other times it offers an opportunity to gauge success or progress. One commemoration that falls into the latter category is today’s third anniversary of the signing of the landmark Food and Drug Administration […]
Gene therapy used to restore hearing in deaf mice
By Nancy Fliesler More than 70 different genes are known to cause deafness when mutated. Jeffrey Holt, PhD, envisions a day when patients with hearing loss have their genome sequenced and their hearing restored by gene therapy. A proof-of-principle study published today by the journal Science Translational Medicine takes a clear step in that direction, restoring hearing in […]
Helping the ACP define ‘professional accountability’
By Westby G. Fisher, MD, FACC Over the weekend, the Executive Vice President and CEO of the American College of Physicians (ACP), Steven Weinberger, MD, sent an email to update their members about the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. In that email, Dr. Weingarten said that “the ABIM MOC program continues […]
Analysis of new draft regulation for medical devices in South Korea
By Stewart Eisenhart, Emergo Group Emergo consultants in Seoul have conducted a thorough analysis of draft Ministry for Food and Drug Safety (MFDS) revisions to South Korean medical device and IVD regulations announced earlier in 2015 to highlight major changes between current and proposed new requirements.
Malaysia extends deadline for medical device registrations
By Stewart Eisenhart, Emergo Group The Medical Device Authority (MDA), Malaysia’s medical device market regulatory agency, has extended its deadline for temporary expedited device registrations to June 30, 2016.
Lina Medical settles morcellator lawsuit
Lina Medical reportedly settled a product liability lawsuit filed over its Xcise laparoscopic power morcellator, a type of device that’s been linked with spreading uterine cancer during uterine fibroid removal surgeries. The lawsuit was filed in March 2014 by Scott Burkart in the U.S. District Court for Eastern Pennsylvania. Burkart’s wife, Donna Burkart, died Feb. […]