FDA floats changes to De Novo pathway

From Medical Design & Outsourcing

• Researchers develop speedy 3D printing
  University of Michigan researchers said they have developed a 3D printing method that’s up to 100 times faster than conventional 3D printing processes. Rather than building up plastic filaments layer by layer, the new approach lifts complex shapes from a vat of liquid at high speed, potentially allowing manufacturers to produce up to 10,000 objects… […]
• MTD Micro Molding named as Plastic News ‘Processor of the Year’ finalist
  MTD Micro Molding (Charlton, Mass.) was recently named as one of Plastic News’s 2018 Processor of Year award finalists. MTD Micro Molding was a finalist in 2017 and 2015 as well. Plastic News awards the Processor of the Year award in polymer technologies to companies based on seven criteria: financial performance, quality, customer relations, employee relations,… […]
• How AI can detect cervical cancer
  Researchers have developed a computer algorithm that they say can analyze digital images of a woman’s cervix and accurately identify precancerous changes that require medical attention. This artificial intelligence approach, called automated visual evaluation, has the potential to revolutionize cervical cancer screening, particularly in low-resource settings. Led by investigators from the National Institutes of Health… […]
• The state of M&A in medtech: Here’s what you may not know
  Buyouts like Medtronic‘s (NYSE:MDT) $1.7 billion acquisition of Mazor Robotics (NSDQ:MZOR) dominated the headlines in 2018, but industry veteran Shayan Bhattacharyya found himself intrigued by the smaller deals that didn’t make the press. “The things that keep me interested are the deals that are the tuck-in, bolt-on acquisitions,” Bhattacharyya said at DeviceTalks West in Costa Mesa, Calif., last month. (Bhattacharyya… […]
• Laird Thermal Systems launches new website
  Laird Thermal Systems has launched its new website with advanced engineering tools. The new website allows design engineers to specify, search and select the optimum thermoelectric module, thermoelectric assembly or liquid cooling system for various applications. Laird Thermal Systems also suggests that the website can shorten product design cycles while improving product or system performance… […]
• 5 top stories that mattered for medtech in 2018
  The medical device industry faced some major challenges over the past year, from increased media scrutiny to regulatory uncertainty in both the U.S. and E.U. It’s worth noting, though, that many things have been going right for medtech. More than half of the roughly 100 largest medical device companies in the world saw their stock… […]
• Instron touts Torsion Add-On 2.0 for biaxial testing
  Instron has launched its new Torsion Add-On 2.0 for universal testing machines. The new add-on is designed to convert axial-only testing machines into biaxial systems that can simulate real-world use of multi-axis loading products. It is able to be added to new or existing Instron 5940 or 5960 series tabletop universal testing machines. Instron’s new… […]
• FDA adds back some workers during partial government shutdown
  The FDA has resumed several health and safety activities that had been halted by the partial government shutdown, now in its 24th day. In a series of tweets on Sunday, FDA Commissioner Scott Gottlieb, M.D. listed the tasks that the agency has added to “excepted, unpaid work.” “It is not business as usual at FDA.… […]
• Presbia reaches ISO medical device quality milestone
  Presbia (Nasdaq:LENS) said today that it has successfully completed the ISO 13485:2016 audit with no major findings. Officials at the Dublin, Ireland–based ophthalmic device company described the audit completion as an essential step toward recertifying under the ISO standard. The company – which has administrative offices and manufacturing in Irvine, Calif. – will receive annual surveillance… […]
• Cook Medical to market Zelegent’s ‘facelift for the soft palate’
  Just a month after receiving FDA 510(k) approval for its new anti-snoring device, startup Zelegent has signed a marketing agreement with Cook Medical, the companies announced. Zelegent’s Elevo kit snoring intervention device employs specially shaped, resorbable, barbed sutures to lift the soft palate by1-4 millimeters, expanding the mean diameter of the airway. In a typical snoring patient… […]
• Avita Medical launches ReCell System in U.S.
  Avita Medical (Cambridge, U.K.) has launched its ReCell Autologous Cell Harvesting Device in the U.S. The system is designed to threat acute thermal burns in patients who are 18 years or older. So far, 36 burns centers have started the purchase authorization process with hospital administrations, 25 burn centers have been trained and certified to use… […]