Southeastern U.S. lifescience groups form alliance

From Medical Design & Outsourcing

• Could this hydrogel repair a broken heart?
  European researchers have developed an injectable hydrogel that they say could help repair and prevent further damage to the heart muscle after a heart attack. The therapeutic effect of multiple injections of this hydrogel into the cardiac tissue was assessed during the first preclinical study of its kind, demonstrating its efficacy for cardiac tissue remodeling… […]
• How EtO plants can avoid lawsuits, cope with stricter regulation
  If EtO industry actors take certain targeted steps now, they can minimize legal exposure, more efficiently manage litigation and be better situated for compliance once new federal regulations are established. Karen Cullinane, Goldberg Segalla The use of ethylene oxide (EtO) to sterilize medical devices came under renewed scrutiny after the Environmental Protection Agency concluded in… […]
• FDA authorizes Q-Collar to help protect athletes’ brains
  The FDA announced today that it authorized the Q-Collar made by Q30 Sports Science for protecting the brain during sports activities. Q30 Sports Science’s Q-Collar is a C-shaped collar worn around the neck designed to apply compressive force to the neck and increase blood volume to help reduce movement of the brain within the cranial… […]
• The top 7 medtech CEO quotes on COVID-19, one year later
  The latest earnings season has provided insights into the future of medtech in the COVID-19 landscape and what certain sectors are seeing as vaccines start to roll out. Since the start of the pandemic, 113.1 million COVID-19 cases have been reported worldwide, according to Johns Hopkins University School of Medicine. The U.S. leads the world… […]
• Pfizer wins FDA nod to store COVID vaccine at normal freezer temps
  The FDA announced today that it is allowing undiluted, frozen vials of the Pfizer-BioNTech COVID-19 vaccine to be transported and stored for up to two weeks at conventional temperatures commonly found in pharmaceutical freezers. The decision should allow for wider distribution of the vaccine to sites that do not have ultra-low temperature freezers. Pfizer asked… […]
• 8 drug delivery innovations you need to know
  The drug delivery space has seen plenty of innovation over the years, and there are no signs of that slowing down any time soon. Improvements upon established technologies like insulin delivery devices and inhalers have been presented by some, while others have unlocked new ways of delivering drugs through a variety of means. Among the… […]
• Hoffer Plastics gains MedAccred certification again
  Injection molding company Hoffer Plastics (South Elgin, Ill.) announced that it has received the MedAccred re-certification from not-for-profit medtech audit provider MedAccred. MedAccred is a supply-chain oversight program of the Performance Review Institute. It conducts critical-process audits for its member OEMs to ensure their suppliers adhere to global regulations and requirements, and helps reduce the number… […]
• UK passes post-Brexit medical device regulation
  The U.K. has enacted a new law governing medical devices and drugs, with a focus on patient safety. The Medicines and Medical Devices Act, introduced in July 2020, establishes the position of commissioner for patient safety to respond to public and patient complaints and concerns about drugs and medical devices. The law was necessitated by… […]
• Integrated Polymer Solutions acquires IRP Group
  Integrated Polymer Solutions (“IPS”), a portfolio company of Arcline Investment Management, announced this week that it has acquired IRP Group. IRP designs and manufacturers elastomeric sealing components from its facilities in Southern California. Founded in 1999, the company is focused on the Class I and II medical device market as well as the aerospace &… […]
• Interpower debuts plugs in new colors
  Interpower announced that its NEMA 5-20 hospital-grade plugs for use in North America now come in molded colors of clear, black or gray on 10-foot lengths of flexible cord. These molded plugs complement the company’s NEMA 5-20 hand-wired hospital-grade plugs. The North American 18A hospital-grade power cord on 14 AWG SJT cable and North American… […]
• Portescap motors gain certification
  Portescap announced that its slotless brushless DC motors for respirators have received ISO 13485:2016 certification. Expanding on ISO 9001, this standard contains specific requirements for parts traceability and risk management activities throughout the design and development stages. It also requires process and software validations at defined intervals. Independent risk management and quality compliance firm DNV… […]