Insightec seeks Parkinson’s indication in Japan for Exablate Neuro

From Medical Design & Outsourcing

• 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… […]
• DeviceTalks Boston: 5 medtech startups you need to know
  From an individually tailored intra-corneal implant to an improved heart pump for open-heart surgery to new exoskeleton technology, there was a variety of medtech to check out during MassMEDIC’s recent Medtech Showcase. The 20th annual showcase, held last week at DeviceTalks Boston, provided a chance for a batch of 20 companies from around the world… […]
• New eye health companies gain funders’ focus
  Startups pioneering less-invasive technologies to treat common eye diseases are changing the outlook for both patients and the industry. A new study by CB Insights revealed that investors have been pouring money into smaller companies in 2017 and 2018, with some FDA approvals to begin marketing their technologies and treatments. These firms are eyeing conditions… […]
• Where medtech is putting its money this November
  Republicans reaped nearly $3.3 million in federal political contributions from the medtech industry in the 2017-18 election cycle, compared with $1.85 million for Democrats, according to data collected by the Center for Responsive Politics, a nonprofit campaign finance watchdog group. Medtech has “historically been a little more Republican than the average industry,” said Andrew Mayersohn,… […]
• India regulators update medical device and IVD oversight programs
  By Stewart Eisenhart, Emergo Group Indian regulators have recently announced several updates regarding their medical device and IVD oversight programs. 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 MedicalDesignandOutsourcing.com or its employees. The post India […]