The outlook for investment-grade medical device companies remains stable even after a 3-year streak of 9 consecutive downgrades, according to a new report from S&P. The downgrade of investment-grade medical device companies was mostly caused by debt-financed mergers and acquisitions, according to S&P. Factors like changes in operating performance trends and financial policy also contributed […]
Mexico proposes changes to medical device regulations in 2018
By Stewart Eisenhart, Emergo Group Mexican regulators are in the early stages of revising various elements of the country’s sanitary registration process for medical devices, including classification, biocompatibility and technovigilance. 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 […]
This brain-sensing headband gives scientists an idea of how brains age
A wireless brain-sensing headband is benefiting more than just the consumer. The valuable data that the headband creates and collects is shedding new light for neuroscience researchers on what happens to our brains as we age. Muse is a wearable device that helps users meditate. It guides the user through meditation by changing the sounds it […]
Chinese FDA updates recall process for medical devices
By Stewart Eisenhart, Emergo Group Medical device regulators at the China Food and Drug Administration (CFDA) have issued a new provision on its recall process for defective devices. 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 […]
7 medtech stories we missed: Feb. 10, 2017
From Glytec partnering to beat diabetes to Biolase, Gramercy Extremity Orthopedics and more getting FDA clearances, here are 7 recent medtech stories we missed this week, but were still worth mentioning. 1. BioTime proposes public offering of common stock Clinical-stage biotechnology company BioTech is intending to offer common stock shares in an underwritten public offering. […]
Missouri University researchers use autograft harvesting to treat chronic wounds
Chronic wound sufferers were able to get skin grafts in an outpatient clinic—all through a Missouri University research team’s work. The researchers used the Acelity Cellutome Epidermal Harvesting System. It is an automated, precise and reproducible process that offers minimal pain and less donor-site trauma. It features suction microsomes that harvest epidermal micrografts automatically, eliminating the […]
Scientists can read minds to communicate with paralyzed patients
An international research team has developed a way to read brain chemistry to enable communication in patients who are paralyzed and unable to talk. The brain-computer interface (BCI) reads the blood oxygen levels in the brain and deciphers the thoughts of the paralyzed patient. The system was tested with four patients with complete locked-in syndrome […]
Medacta International acquires Vivamed
Medacta International has announced its acquisition of the Austrian distributor Vivamed. The acquisition went into effect on Feb. 1. Medacta, a privately held and family-owned global designer of joint replacement and spinal surgery products, hopes to strengthen its presence in Austria and facilitate future development and investments in the market with this acquisition. It also […]
Maxon Motor spending $30 million on new Innovation Center
Maxon Motor is investing roughly $30 million (CHF 30 million) to add a new Innovation Center to its headquarters in Switzerland. The expansion construction of the new Innovation Center is set to begin in February and expected to be completed and ready for use by summer 2018. The construction of the new Innovation Center is […]
New imaging agent detects metastatic prostate cancer cells
The first-in-human application of an imaging agent has helped identify early and advanced stages of prostate cancer. The new agent, a PET radiotracer, has also shown to be safe and effective, according to the researchers who developed it. The agent, gallium-68 (Ga-68), targets gastrin-releasing peptide receptors and integrin αvβ3. When both receptor types are expressed, […]
New Indian medical device regulations for 2017
By Stewart Eisenhart, Emergo Group The Indian government is planning a significant overhaul of its system for regulating medical devices and IVDs. Emergo is still analyzing the new Medical Device Rules 2017 to determine how the new regulations will affect registration requirements in India, but we can now report on some general points found in […]