3D-printed PEEK-based Cranial Implants Cleared by FDA
3D Systems has received 510(k) clearance from the US Food and Drug Administration (FDA) for its 3D-printed, patient-specific cranial implant system. The VSP PEEK Cranial Implant includes a complete FDA-cleared workflow comprising segmentation and 3D modeling software, 3D Systems’ EXT 220 MED 3D printer, Evonik’s VestaKeep i4 3DF polyetheretherketone (PEEK) resin, and a pre-defined production process.
How the Shockwave Reducer implant is designed to treat refractory angina
After buying the Neovasc Reducer, Shockwave plans another attempt at FDA approval — and to explain how the implant treats refractory angina.
3D printing tips for new functionality and maximum reimbursement with orthotics and prosthetics
Nine tips for improvements in patient outcomes, function and materials when 3D printing O&P devices.
Protolabs 3D Printing Report Shows Growth Exceeding $28B
3D printing has evolved to occupy an established place in manufacturing today. As it has become a more widely applied industrial manufacturing process, the industry is coming of age. A large network of specialized companies providing support and solutions for a range of production processes has emerged.
Advancements in Digital Biomarkers & Medical Diagnostics
The quickly evolving capabilities of artificial intelligence (AI) will continue to dramatically impact all facets of the healthcare industry for the foreseeable future. At the root of the seemingly limitless potential to improve patient care is the field of diagnostics, where advancements in medtech devices and biomarkers are propelling earlier diagnoses into more comprehensive care planning for patients and more favorable prognoses.
How to Navigate FDA’s Medical Device Cybersecurity Recommendations
FDA is cracking down on medical device cybersecurity. In response to an increase in healthcare cybersecurity threats, prevalence of connected devices, and pressure from the United States Government Accountability Office (GAO), the agency issued final guidance on medical device quality system and premarket submission requirements. In March, FDA released an update to clarify what devices must comply, as well as to give more specifics on the proposed cybersecurity plan.
EU MDR Poses Challenges for Manufacturers
To provide an overview of EU MDR, we turned to Abhishek (Abhi) Gautam, MS, EMBA, who is an executive engineer at DDL Inc., an ISO/IEC 17025 accredited full-service testing lab that provides package, product, and materials testing to the medical device and pharmaceutical industries, headquartered in Eden Prairie, Minnesota.
Programmable Materials Help Heal Broken Bones
A new study that integrates machine learning, optimization, 3D printing, and stress experiments allowed engineers to gain insight into these natural wonders by developing a material that replicates the functionalities of human bone for orthopedic femur restoration.
‘Smart Skin’ Monitors Biological Signals on Demand
Penn State researchers recently developed an adhesive sensing device that seamlessly attaches to human skin to detect and monitor the wearer’s health. The writable sensors can be removed with tape, allowing new sensors to be patterned onto the device.
On-Skin Wearable Bioelectronic Device Uses Breathable, Stretchable Material
A team of researchers at the University of Missouri have made a significant breakthrough in their ongoing development of an on-skin wearable bioelectronic device. Zheng Yan’s lab, which specializes in soft bioelectronics, recently added an important component to the team’s existing ultrasoft, breathable and stretchable material. The key feature: wireless charging — without batteries — through a magnetic connection.