Medical Device Developments Weekly: 13/12/23
Medical Device Developments
Latest news and insight on innovations in the Medical Device sector.
The latest insight and analysis from the global medical device market from the last week courtesy of Medical Device Developments
Exactech receives FDA 510(k) approval for GPS Ankle system
GPS Ankle is an advanced technology that connects preoperative planning with real-time intraoperative instrument guidance to ensure resections meet the surgical plan.
The system leverages unique active tracker technology and a compact touchscreen tablet in the sterile field to provide surgeons with dynamic intraoperative feedback.
It is also the world’s first surgical navigation system for total ankle arthroplasty (TAA), claims the US-based medical device company.
Exactech said its GPS Ankle is the latest addition to its Active Intelligence dynamic ecosystem of technologies and smart solutions.
OSSIO secures FDA approval for OSSIOfiber bio-integrative fixation technology
The US health agency approved the technology for use in orthopaedic surgery for children and adolescents, who need bone fractures fixed, osteotomies, or fusions.
The approval now allows the use of OSSIOfiber compression screws and trimmable fixation nails in children as young as two years through 21 years, in standard clinical practice.
OSSIO made the non-permanent implants using its OSSIOfiber intelligent bone regeneration technology to address the limitations of permanent metal hardware and conventional implants.
They are made using a unique mineral fibre matrix with bio-integrative properties, which allows surgeons to treat patients in a more biologically friendly way, leaving no permanent residues behind.
BD secures FDA 510(k) approval for BD MiniDraw capillary blood collection system
The MiniDraw system is designed to collect blood samples from a fingerstick to help produce lab-quality results for some of the commonly ordered blood tests.
It is intended for low-volume blood collection for a lipid panel, select chemistry tests, and haemoglobin and hematocrit (H&H) testing, for diagnosis of chronic conditions.
BD said that its MiniDraw capillary blood collection system provides a sample that produces lab-quality blood test results from a fraction of what is required for traditional venous collections.
It is less invasive than traditional venous blood collection methods, more convenient for the patients, and eliminates the need for a phlebotomist to collect blood from a vein.
Medtronic, Cosmo Pharmaceuticals expand partnership to boost AI-powered endoscopy
Medtronic and Cosmo Pharmaceuticals previously partnered for the GI Genius intelligent endoscopy module.
The expanded, exclusive global partnership aims to advance endoscopy by harnessing the power of AI technology to improve patient outcomes.Under the terms of the expanded agreement, Medtronic will make an upfront payment of $100m to Cosmo Pharmaceuticals , along with a double-digit royalty on net sales.
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In addition, the medical device maker will pay up to $100m in potential milestone payments, expected by the end of 2024.
GT Medical Technologies, Inc. to acquire Perspective Therapeutics’ radioactive seed business
The radioactive seeds form an important component of GT Medical Technologies, Inc. ’s GammaTile Therapy, intended for patients undergoing brain tumour resection surgeries, who need radiation therapy.
GammaTile features bioresorbable collagen embedded with Cesium-131 radioactive seeds.
The Surgically Targeted Radiation Therapy (STaRT) is designed to start radiation immediately after tumour removal to help eradicate residual tumour cells.The acquisition is anticipated to close in the first quarter of 2024, subject to the satisfaction of certain customary closing conditions.
Thermo Fisher Scientific rolls out new respiratory diagnostic testing solutions
Thermo Fisher Scientific rolled out Thermo Scientific KingFisher Apex Dx, an automated nucleic acid purification instrument.
It has also introduced Applied Biosystems MagMAX Dx Viral/Pathogen NA Isolation Kit for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens.
The two products will provide laboratories with in-vitro diagnostic (IVD) and in-vitro diagnostic regulation (IVD-R) approved automated sample preparation solutions, said the company.
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