Gottlieb: Shutdown means furloughs for 42% of FDA staff

From Medical Design & Outsourcing

• These medtech companies raised the most VC last year
  Perhaps there’s a ray of hope that venture capital funding is recovering a bit for the medical device industry. VC firms invested more than $2.8 billion in 2017, an increase of more than $647 million from 2016, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There were a total 229 deals involving […]
• Medtech stories we missed this week: Jan. 19, 2018
  From Privi Medical’s FDA clearance to OrthoXel getting FDA clearance and CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Privi Medical wins FDA nod for hemorrhoid device Privi Medical has received FDA clearance for its Instalief Hemorrhoids Treatment device, according to a Jan. 18 news […]
• How blockchains could empower patients and secure data
  Blockchains are best known as the technology behind cryptocurrencies such as Bitcoin. But the founders of a young Atlanta-based company called Patientory think they could have another important use – securing health data and empowering patients along the way. Secure access to patient data is a major issue for the healthcare industry. Patients have a […]
• Phillips-Medisize’s increased business to benefit Molex plant in Arkansas
  Phillips-Medisize today announced a doubling of production for an undisclosed fast-growing medical customer with a take-home diagnostic kit for cancer detection – with benefits for the plant that Phillips-Medisize’s parent Molex runs in Little Rock, Ark. Phillips-Medisize, which is based in Hudson, Wis., did not disclose the identity of the customer, which it described as a leader […]
• GlobTek touts EAC-certified off-the-shelf power supplies for medical, other applications
  GlobTek is touting the wide variety of EAC-certified power supplies that it is offering for applications including medical, information technology equipment, household and more. A full list is available on the Northvale, N.J.–based company’s website.  EAC certification, formerly known as the Russian GOST-R certification, implements a new logo (EAC mark)  – and involves the implementation […]
• Robotic spine surgery is getting a real-time image guide boost
  For the first time, surgeons at Johns Hopkins Hospital were able to harness real-time image guidance during a robotic spine surgery procedure to insert screws into a patient’s spine. The process offers a marked improvement over the accuracy of placement compared with other image-guided procedures. Dr. Nicholas Theodore – professor of neurosurgery at the Johns Hopkins University […]
• Cardiovascular Systems inks partnerships with OrbusNeich, Integer
  Cardiovascular Systems (Nasdaq: CSII) announced today that it is expanding its product portfolio through new partnerships with OrbusNeich and Integer. The OrbusNeich partnership makes St. Paul, Minn.–based CSI the exclusive U.S. distributor of Hong Kong–based OrbusNeich‘s balloon products. The deal with Frisco, Texas–based Integer (NYSE: ITGR) involves Integer producing CSI-branded Zilient guidewires. Cardiovascular Systems CEO […]
• FDA to expedite release of recall information
  Douglas Stearn, FDA When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant public […]
• IRS won’t enforce penalties on medical device tax
  The U.S. Internal Revenue Service yesterday said it won’t enforce penalties on companies making late payments on the medical device tax for the first three months of this year. The 2.3% excise tax on U.S. medical device revenues was in effect for two years before a two-year moratorium went into effect for 2016 and 2017. It went […]
• Is tax reform good or bad for medical device companies?
  Medical device companies and others in the healthcare sector stand to benefit from the tax reform Congress passed at the end of 2017, but the picture isn’t entirely rosy, according to a new report from S&P Global Ratings. In many ways, the report offers a corrective to the bullish statements coming from corporate CEOs such […]
• FDA releases top 3 medical device regulation goals
  FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today. The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices. […]