DreaMed Diabetes has won CE Mark clearance for its Advisor Pro decision-support platform, designed to help healthcare professionals manage insulin therapy for their Type I diabetes patients. The company’s cloud-based platform provides personalized insulin treatment plans by combining data from insulin pumps and continuous glucose monitors. Using machine learning techniques, the system analyzes all of the […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Abiomed wins expanded Impella FDA nod for elective, urgent high-risk PCI
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5 and Impella CP heart pumps, now cleared for use during elective and urgent high risk percutaneous coronary intervention procedures. With the expansion, the Impella heart pump is cleared for use with patients with severe coronary artery disease, complex anatomy and a number […]
TransEnterix files expanded 510(k) application for Senhance robotic platform
TransEnterix (NYSE:TRXC) said today it filed an FDA 510(k) submission looking to expand the indications for its Senhance robotic surgical platform to include laparoscopic inguinal hernia and laparoscopic cholecystectomy surgeries. The Research Triangle Park, N.C.-based company said that with the additional indications, its Senhance system would be cleared for use in the most common abdominal surgeries in […]
Glooko wins FDA nod for mobile insulin dosing system
The FDA has approved Glooko‘s mobile insulin dosing system, which is designed to titrate long-acting insulin for people with Type II diabetes. The company’s system accesses blood glucose data directly from the user’s glucose meter so that the user doesn’t have to manually enter their fasting glucose values. Then, it analyzes those levels to recommend insulin […]
Sandoz wins FDA nod for generic, injectable MS drug
Sandoz said today that the FDA has approved its Glatopa glatiramer acetate injection as a generic version of Copaxone to treat relapsing forms of multiple sclerosis. The therapy, which is given three days per week, is administered using the Glatopaject injection device. Get the full story at our sister site, Drug Delivery Business News.
Abiomed touts expanded Impella heart pump indication, launches Women’s Initiative
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, now cleared to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy. The approval follows a previous FDA indication the Danvers, Mass.-based company won in April […]
Canon Medical wins FDA nod for Vantage Galan 3T XGO MRI
Canon (NYSE:CAJ) Medical Systems said today it won FDA clearance for its Vantage Galan 3 tesla XGO edition magnetic resonance imaging system. The newly cleared system features the Saturn X gradient and a 30% improved signal-to-noise ratio, the the company claims, improving the resolution of brain diffusion weighted imaging. Canon said the system also features improved cardiac […]
Avita wins expanded FDA compassionate use for ReCell device
Avita Medical (ASX:AVH) said today the FDA approved an expansion to the number of patients treatable by its ReCell device under the compassionate use investigational device exemption program by 20 individuals. The ReCell autologous cell harvesting device is designed to use the patient’s own skin cells to treat a variety of skin issues, including burns, reconstructive and […]
Medtech, healthcare stakeholders offer ideas to improve FDA oversight, regulation and patient access
Major players and medtech industry groups have offered their opinions as the FDA looks to review and improve its information collection requirements and regulatory oversight. Commentary came in from companies Johnson & Johnson (NYSE:JNJ), Abbott (NYSE:ABT) and Cook Medical and industry groups AdvaMed, the Medical Imaging & Technology Alliance, the Pharmaceutical Research and Manufacturers of America and […]
Icon Bioscience wins FDA nod for long-acting cataract surgery drug
Icon Bioscience said today that the FDA has approved its application for Dexycu, a long-acting therapy designed to treat inflammation in patients who have had cataract surgery. More than four million cataract surgeries are performed each year in the U.S., according to the privately-held biopharma company, and most patients treat inflammation in their eyes using medicated […]
FDA, NRC approves RadioGenix medical isotope production from NorthStar Medical Radioisotopes
The FDA and Nuclear Regulatory Commission today approved NorthStar Medical Radioisotopes‘ RadioGenix system designed to produce Technetium-99m, which it said is the most widely used radioisotope in medical imaging. Guidance from the NRC, an independent agency created by congress to license and regulate the civilian use of radioactive materials, was issued to allow the system […]