Regenerative medicine company Locate Bio announced today that the FDA has granted breakthrough device designation to a bone graft/antibiotic combination designed to combat chronic bone infection, also known as osteomyelitis. Osteomyelitis is a progressive, inflammatory infection of the bone, usually caused by bacteria and is estimated to account for up to 50% of all non-trauma […]
FDA
FDA produces list of ‘essential’ devices, drugs for health, military emergencies
The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that the Trump administration ordered the agency to buy domestically to fight the novel coronavirus and future health and military crises. Devices on the list include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, devices […]
Report: Will Dr. Hahn crack under political pressure?
Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration. Hahn has been squeezed between expressing his professional […]
Tandem Diabetes Care wins expanded FDA indication for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) announced today that it won an expanded pediatric indication from the FDA for its t:slim X2 insulin pump. The t:slim X2 with Control-IQ technology won FDA clearance for controlling Type 1 diabetes in December, which was followed by a commercial launch in the U.S. the next month. Tandem touts t:slim X2 with […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]
Clinical trials ramping up for potential coronavirus-fighting drugs
Bausch Health (NYSE:BHC) announced today that it initiated a clinical trial program in Canada to investigate the use of Virazole for treating COVID-19. With today’s announcement, Bausch joins Eli Lilly (NYSE:LLY) and Care Access Research, which both announced clinical testing of coronavirus therapies last week. Bausch’s Virazole is currently approved in the U.S. and Canada, among other […]
FDA approves Cipla’s generic albuterol inhaler
The FDA approved the first generic version of the Proventil HFA (albuterol sulfate) metered-dose inhaler for treating bronchospasm. The FDA indicated the generic inhaler from Cipla for the treatment or prevention of bronchospasm in patients four years of age or older with reversible obstructive airway disease. It also aids in the prevention of exercise-induced bronchospasm […]
Companion Medical wins FDA nod for InPen diabetes management system
Companion Medical announced that it won FDA clearance for its InPen bolus calculator for fixed dosing and meal estimation in diabetes management. The new bolus calculator is designed to account for the user’s current glucose level and active insulin to remove the guesswork from insulin dosing. Companion Medical touts the system as the first of […]
7 medtech advances to improve diabetes treatment
Medtech and pharmaceutical companies have made several important strides over the past year when it comes to improving diabetes treatment. Multiple treatments and technologies have cleared regulatory hurdles and are now hitting the market and making the process of living with diabetes that much more manageable. Several different styles of therapy and devices have come […]
FDA wants feedback on combination products guidance
The FDA is seeking comment from sponsors of combination products on how they want the agency to respond to their scientific and regulatory questions. Their responses will help shape a new draft guidance, according to the agency. The FDA defines a combination product as one composed of any combination of a drug, device and/or a […]
