FDA clears remote adjustments for Cochlear’s Nucleus implants

From Medical Design & Outsourcing

• Canfield Scientific acquires Visiomed
  Canfield Scientific recently acquired Germany-based dermoscopy company Visiomed. The financial details of the deal were not disclosed. “The addition of Visiomed’s best-in-class optical and digital dermatoscopes are a perfect extension to our imaging portfolio,” Doug Canfield, president of Canfield Scientific, said in a press release. “Furthermore, their commitment to excellence and organizational culture was a… […]
• How to use digital health in clinical trials to improve patient engagement
  Digital health technology can improve reporting of patient data during clinical trials, but it can also lead patients to drop out.  By Vicki Anastasi and Matthew McCarty, ICON Plc Digital health technologies are changing the way companies design and implement clinical trials, shifting responsibility from investigator to patient. Adding multiple digital health technologies into trial… […]
• Hancock Jaffe inks CoreoGraft development deal with Texas Heart Institute
  Hancock Jaffe Laboratories has entered a sponsored research agreement with the Texas Heart Institute to develop the company’s CoreoGraft. CoreoGraft is an off-the-shelf conduit that is designed to be used for coronary artery bypass surgery. “We are fortunate to be in a position to be highly selective of the projects we accept at Texas Heart… […]
• FDA launches pilot to expand special 510(k) market pathway
  By Stewart Eisenhart, Emergo Group Medical device regulators at the US Food and Drug Administration has initiated a new pilot program for expanded eligibility in the agency’s Special 510(k) pathway, potentially easing market compliance requirements for more manufacturers whose devices have undergone modifications. Get the full story here at the Emergo Group’s blog. The opinions… […]
• Eximo Medical receives FDA clearance for laser system
  Eximo Medical recently announced that it has received FDA 510(k) clearance for its B-Laser Atherectomy System that is designed for peripheral artery disease. The B-Laser system is a 355nm wavelength laser that is designed to treat multiple vascular issues. The system has been cleared for use in the treatment, including atherectomy, of infrainguinal stenoses and… […]
• 7 electronic design problems that boost medical device costs
  When developing electronic devices, design for manufacturing (DFM) often takes a back seat without regard for the long-term consequences. Even if the manufacturing cost is within the target, companies should consider and address the device’s manufacturability.  Mike Labbe, Valtronic Products that are challenging to build typically result in longer lead times, lower margins, and possibly… […]
• FDA clears SpineEx’s Sagittae spinal fusion device
  SpineEX recently received FDA 510(k) clearance for its Sagittae lateral lumbar interbody fusion (LLIF) device. Sagittae is a personalized, adjustable and expandable LLIF device that is designed to minimize impaction while maximizing indirect decompression. It also offers a large graft space that is useful for lumbar fusion procedures. The Sagittae is designed for up to… […]
• Your device design looks great. Now how do you get reimbursement?
  Until recently, the main focuses of medical device companies were designing devices and earning regulatory clearance for their new technologies. How times have changed. While innovative design and FDA approval are important for market entry, reimbursement is now a top concern for medical device CEOs, their investors and other stakeholders. Tom Hughes, Regulatory and Clinical Research… […]
• What “no-deal” Brexit means for medical devices
  By Ronald Boumans, Emergo Group The UK will leave the European Union on March 29, 2019 – Brexit day. On that day the EU will lose an important Member State, and the UK will no longer have direct access to the 27 remaining Member States. Therefore both the EU and the UK want to work… […]
• Medtech issues again take center stage in Minn. Congressional races
  The medical device industry is yet again positioned to play a major role in Minnesota congressional races. Incumbent Rep. Erik Paulsen (R-Minn.), who has been a longtime supporter of the medtech industry and led numerous attempts to repeal the medical device tax, is facing a tough re-election campaign. Paulsen is facing off against 48-year-old liquor… […]
• These 10 medtech companies care a lot about research
  These 10 medical device companies spent the largest portion of their budgets on research and development. Here’s a look at what they produced. Each year, Medical Design & Outsourcing compiles a list of the top 100 medical device companies across the globe and ranks the companies based on annual revenue for the most recent fiscal… […]