Additive manufacturing, often referred to as 3D printing, has evolved considerably over the past few decades, and plays a significant role in the world of orthopedic devices. Despite numerous technological advances, additive manufacturing (AM) still accounts for a small share of the device market and may never overwhelm traditional manufacturing for the med-tech industry due to a number of limitations.
Blue Ocean Spine GmbH has won a major investment from SHS GmbH, also from Tuttlingen in Germany, to develop its next-generation functional spinal implant. The two companies are declining to disclose the size of the series A investment.
PARIS – Solvay SA is partnering with Printerprezz Inc. to develop 3D printing technology using Selective Laser Sintering (SLS) for implants and other medical devices.
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) has unveiled its final regulatory requirements for personalized medical devices, including 3D-printed devices, that go into effect on Feb. 25, 2021. Under the previous framework, custom-made medical devices were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (ARTG).
Wellcome Leap has launched its first program, dedicating $50 million to help develop human tissues, organoids and full organs. The Human Organs, Physiology and Engineering (HOPE) program is looking to bring biologists and engineers together to develop both therapeutic organs as well as organs that can be used in vitro to help discover and develop new medications.
TORONTO – Virtual reality (VR) platform developer Realize Medical Inc. is collaborating with Lausanne, Switzerland’s Logitech International SA on what the Ottawa-based med tech calls “the world’s first VR platform for creating patient-specific 3D medical models.”
PERTH, Australia – Startup Inventia Life Science Pty. Ltd. has received two major investments from the Australian government to accelerate the development of a robotic device that prints a patient’s own skin cells directly onto a burn or wound. Named Ligō from the Latin “to bind,” the device could revolutionize the way surgeons approach wound repair.
The FDA’s weekly town hall on testing for the COVID-19 pandemic included the usual range of concerns about test performance, but concerns regarding swabs and sample sites continue to mount. The predicament has led to the announcement that the FDA along with the National Institutes of Health (NIH) will hold a May 15 town hall regarding swabs, with a particular interest in swabs produced via additive manufacturing.
The U.S. FDA has granted emergency use authorization (EUA) to New Haven, Conn., startup Vent Multiplexor LLC for its emergency rescue co-ventilation device. Developed in collaboration with Yale New Haven Hospital, the Vent Multiplexor enables individualized mechanical ventilation of two adults on a single ventilator – lessening demand for more critical care machines in the ongoing COVID-19 outbreak.
As health care workers face critical shortages of personal protective equipment (PPE) to deal with the COVID-19 crisis, 3D printing companies, medical device manufacturers and other organizations are stepping up to produce face shields, ventilators and other needed supplies. For its part, Rehovot, Israel-based Stratasys Ltd. has assembled a coalition of more than 150 companies and universities to produce 3D-printed visors and clear plastic face shields. The coalition aims to produce up to 16,000 face shields per week by the end of next week.