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DevarshVyas posted a blog entry in Devarsh Vyas's Biomedical 3D Printing Blogs3D printing technologies have opened up the capabilities for customization in a wide variety of applications in the medical field. Using bio-compatible and drug-contact materials, medical devices can be produced that are perfectly suited for a particular individual. Another trend enabled by 3D printing is mass customization, in that multiple individualized items can be produced simultaneously, saving time and energy while improving manufacturing efficiency. 3D printers are used to manufacture a variety of medical devices, including those with complex geometry or features that match a patient’s unique anatomy. Some devices are printed from a standard design to make multiple identical copies of the same device. Other devices, called patient-matched or patient-specific devices, are created from a specific patient’s imaging data. Commercially available 3D printed medical devices include: Instrumentation (e.g., guides to assist with proper surgical placement of a device) Implants (e.g., cranial plates or hip joints) External prostheses (e.g., hands) Prescription Glasses Hearing Aids In summary, the 3D Printing medical device market looks exciting and promising, Various Reports and surveys suggest the unexpected growth and demand for 3D Printing in medical device industry and it is expected to blossom more but a number of existing application areas for 3D printing in healthcare sector require specialized materials that meet rigid and stringent bio-compatibility standards, Future 3D printing applications for the medical device field will certainly emerge with the development of suitable additional materials for diagnostic and therapeutic use that meet CE and FDA guidelines.
mplishka posted a topic in News and Trending TopicsInteresting guidance from the FDA. It will cover 3d printing custom devices. http://www.dicardiology.com/article/fda-changes-rules-custom-medical-device-exemptions?eid=323035710&bid=1562576
mattjohnson posted a blog entry in Matt Johnson's Biomedical 3D Printing BlogThree-dimensional (3D) printing technology was invented in the 1980s to create mechanical prototypes for the manufacturing sector. Healthcare professionals and researchers soon realized the potential of this novel technology in the field of medicine and began depositing desired materials on specific substrates to create anatomical models, surgical instruments, prosthetics and even body parts that could be customized to meet the needs of the user. Scientists rely on MRI and CT scan images of the patients to obtain the exact dimensions for the target object, feed the image data into one or more software programs, and let the 3D printer do its job. Millions of dollars have been spent on 3D medical printing and bioprinting research in last decade, and such endeavors have led to the creation of several innovative solutions. Nonetheless, many of these products can't benefit the patients until they come with the Food and Drug Administration’s (FDA) seal of approval. Recently, the federal agency woke up to the needs of the 3D medical printing industry and issued guidance for 3D printed medical devices based on design, manufacturing and device testing information. Many 3D printed products have received FDA approval, some of which are highlighted below. The O2 Vent a 3D Printed Solution for Sleep Apnea In April, 2016, Oventus, an Australian startup, received FDA approval for its titanium mouth device called the O2 Vent. The customizable oral device contains airways that reach the back of the patient’s mouth bypassing obstructions caused by nose, soft palate or tongue. The 3D printed device is expected to benefit over 37 million Americans suffering from sleep apnea while helping Oventus enter the $50 billion global sleep disorder market. Spritam, the FDA approved 3D Printed Drug In another bold step, the FDA approved a 3D printed drug, Spritam, to treat partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures. Its manufacturer, Aprecia Pharmaceuticals, used the ZipDose 3D printing technology to create a pill that disintegrates in the mouth with very little water and is especially beneficial to patients who cannot swallow their medication during seizures. The high-dose drug can impact over 2.4 million American adults with epilepsy, as per an article published in the March, 2016, edition of Forbes. Lateral Spine Truss System Another innovative product, the Lateral Spine Truss System, also received a go-ahead from the federal agency in 2016. It consists of 3D printed orthopedic implants, manufactured by 4WEB Medical, that allow for integrated instrumentation and customization. They come in sterile packs and can be used with most mainstream spinal surgery techniques. The goal is to deliver functional implants with a structural design. CASCADIA Cervical and CASCADIA AN Lordotic Oblique Interbody Systems The FDA has also issued a 510 (K) clearance to K2M for CASCADIA Cervical and CASCADIA AN Lordotic Oblique Interbody Systems with Lamellar 3D Titanium technology. While CASCADIA Cervical Interbody System is an intervertebral body fusion device, the CASCADIA AN Lordotic Oblique Interbody System has been designed for transforaminal-lumbar interventions. K2M expects its product to help the approximately 800,000 men and women who undergo cervical fusion each year. 3D Printed Cranial Implants Brazilian and U.S. based BioArchitects collaborated with Swedish 3D printing company ArcamAB to generate patient-specific cranial implants. The company used Electron Beam Melting technology and lightweight titanium alloys to form the implants. Although the FDA approval is restricted to the non-loadbearing bones of the skull and face, healthcare professionals are hopeful that the technology can treat a variety of conditions ranging from trauma to congenital abnormalities. While 3D printed products with FDA approvals strive to become more accessible to all patients, others are waiting in the pipeline for a green light from the agency. Licensing requirements include extensive lab testing and clinical evaluation. Doctors and scientists are, however, confident the products will meet the criteria and get the necessary endorsements from the FDA to eventually help transform medicine. Sources: http://www.news-medical.net/news/20160407/Oventus-gains-FDA-clearance-for-medical-device-designed-to-alleviate-snoring-OSA.aspx http://www.todaysmedicaldevelopments.com/article/3d-printed-medical-device-4web-8316/ http://www.meddeviceonline.com/doc/k-m-enhances-d-printed-spine-portfolio-featuring-lamellar-d-titanium-technology-0001
The US Food and Drug Administration (FDA) just released guidance on the use of 3D printing for medical purposes in the USA. http://threedmedprint.springeropen.com/articles/10.1186/s41205-016-0005-9 I am particularly interested in how the FDA approval applies to software used to generate models that are used for surgical planning but not diagnostic purposes? It seems, from the article, that if the purpose of the 3D printed model is merely for thinking about or planning a surgery, it is a "visual aid" and FDA approved software is not required. The technical term is a "medical image hardcopy device," examples of which are laser printers and cameras. If it is used for diagnosis, then it should be discussed with the FDA. And if use for implantable medical devices or surgical cutting guides (i.e. stuff that touches the patient), then the whole process is under FDA approval. This correlates to what the paper's first author (Matthew Di Prima from FDA) said at the 2015 Bioinformatics Festival during this talk. Key part is at 4:41. https://videocast.nih.gov/summary.asp?Live=15417&bhcp=1 Anyone have any thoughts about this?