Report: Apple in pursuit of FDA approval for iWatch-connected heart app

From Medical Design & Outsourcing

• Seisa Medical closes $42.5 million recapitalization and acquisition line
  Seisa Medical (El Paso, Texas) announced that it has closed a $42.5 million senior secured credit facility with Sagard Credit Partners. Most of the funds from the deal will be used to be fees and expenses from the transaction while administering a dividend to shareholding and completing acquisitions. “We are excited to begin this relationship […]
• MD&M West 2018: Medtech supplier innovations you need to know
  Updated Feb. 2 More than 20,000 engineers and executives gather and network for the annual MD&M West – one of the largest annual medical device manufacturing events. The event is set to take place at the Anaheim Convention Center in Anaheim, Calif. on Feb. 6-8. The event houses multiple industry manufacturers that showcase some of their latest technologies and […]
• Heraeus opens new Costa Rica manufacturing facility
  Heraeus Medical Components announced that it has recently opened its new manufacturing facility in Costa Rica where the company is expected to produce more than two million guidewires this year. The new facility, located in Cartago, Costa Rica, was designed to supply local and U.S.-based medical device companies with advanced component and sub-assembly solutions. The […]
• EU gives Brexit notice to economic operators and impact for medical device industry
  By Ronald Boumans and Annette van Raamsdonk, Emergo Group A new notice from the European Commission lays out how Brexit will impact economic operators including medical device companies, Authorized Representatives and Notified Bodies. Get the full story here at the Emergo Group’s blog. The opinions expressed in this blog post are the author’s only and […]
• This remote-controlled immunotherapy system targets and kills cancer cells
  University of California researchers have developed a remote-controlled therapy system that identifies and kills cancer cells using ultrasound. The ultrasound-based system is able to non-invasively and remotely control the genetic process in immune T cells to identify and kill cancer cells. According to the researchers, the ability to non-invasively and remotely manipulate cells at a […]
• NAMSA expands medical device testing services
  NAMSA (Toledo, Ohio) recently announced that it has launched its Analytical Services Laboratory in Obernburg, Germany to further expand access to accelerated product development and testing services. The company’s new facility offers European device manufacturers a facility that meets ISO 10993-18 testing requirements. It will also offer exhaustive extraction, FTIR, GC-MS, LC-MS and ICP-MS services in […]
• Private equity-backed Regatta Medical buys majority stake in Resonetics
  Private equity firm GTCR’s portfolio company Regatta Medical said today it acquired a majority stake in Resonetics, with its current management team led by CEO Tom Burns slated to continue their roles with the company. The deal, which included an increased investment from previous owner Sverica, is slated to close sometime in early February, Boston-based […]
• Eudamed development on schedule
  By Ronald Boumans, Emergo Group European regulators appear on track to launch the Eudamed database for medical devices in March 2020, but stakeholder accessibility may take longer than that. 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 […]
• Antidote looks to leverage AI, travel e-commerce tech to improve clinical trial enrollment
  Clinical trial artificial intelligence company Antidote is looking to improve access to and enrollment in clinical trials using technology from the e-commerce world, according to a Wired report. Former travel and airline fare aggregator Kayak VP Pablo Graiver is heading the operation, which streamlines access to clinical trials for patients seeking them out.   Read […]
• Charting the FDA’s course for 2018-2020
  By: Jeff Shuren, M.D., J.D. Since 2012, we at the Center for Devices and Radiological Health have set as our North Star the vision of patients in the U.S. having access to high-quality, safe, and effective medical devices of public health importance first in the world. “First in the world” is not about a competition […]
• Agilent inks incubator deal with USC
  Agilent Technologies announced that it has formed a scientific collaboration with the University of Southern California Michelson Center for Convergent Bioscience. The collaboration will help create an Agilent Center of Excellence in Biomolecular Characterization. The new center will be located in Michelson Hall at USC. The research facility will help establish a convergence of researchers […]