FDA grants 510(k) approval for Speedboat RS2 device and the CROMA platform to treat bowel lesions.- Creo Medical Group.
Creo Medical Group plc , a medical device company focused on the emerging field of surgical endoscopy, announces that it has received 510(k) clearance from the FDA for its Speedboat RS2 device and the CROMA platform. Speedboat RS2 is the first of a range of medical devices in development, powered by the CROMA platform, and enables the minimally invasive removal of early stage cancerous and pre-cancerous lesions in the bowel through an endoscopic procedure. This FDA Clearance has been received ahead of schedule, with the FDA review process being completed in 49 calendar days from submission. Accordingly, Creo will now assess the necessary steps to bring forward the implementation of its commercial plans for the US.
Speedboat RS2 is the first device developed for use with the Company's generator, CROMA. It harnesses the cut and coagulation capability of CROMA and enables the removal of early stage cancerous and pre-cancerous lesions. The use of Speedboat RS2 reduces the risks associated with incisions which are necessary for laparoscopic procedures and can reduce the length of hospital stay. Endoscopy has been a rapidly expanding practice due to the advent of colorectal cancer screening in most healthcare systems. This has driven growth in equipment and devices to enhance the ability to screen and detect early stage and pre-cancerous lesions in the GI tract.
Comment: Speedboat RS2 device received CE Mark in March 2017.
Comment:The Speedboat RS2 delivers both bipolar radiofrequency (RF) and microwave energy through its tip. The CROMA generator is used to actually energize the Speedboat RS2 device, delivering RF energy to resect and dissect tissue, while supplying microwaves to ablate and coagulate.
Related news and insights
AbbVie has announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (Skyrizi 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with methotrexate (MTX), for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Merck Inc., announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected by the end of the year.
Merck Inc., and Eisai announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted positive opinions recommending approval of the combination of Keytruda, Merck’s anti-PD-1 therapy, plus Lenvima (marketed as Kisplyx in the European Union [EU]) for the treatment of advanced renal cell carcinoma [RCC]), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for two different indications.