The FDA has given breakthrough device approval to a system to deliver tympanostomy tubes to young children with recurrent ear infections, in a physician’s office and under local anesthesia. Tusker Medical’s Tubes Under Local Anesthesia (Tula) system consists of the ionic anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of […]
Research & Development
Cook Regentec launches blood filtration trial for critical limb ischemia
Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular […]
Frequency Therapeutics registers $100m IPO
Frequency Therapeutics has registered an initial public offering of common stock worth $100 million. Woburn, Mass.-based Frequency Therapeutics did not disclose the number of shares it seeks to sell or the price range of the offered units. The company applied to the Securities and Exchange Commission have its common stock listed on The Nasdaq Global […]
Medtronic’s In.Pact AV DCB meets endpoints in trial
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]
Bigfoot Biomedical inks deal with Pittsburgh health system
Bigfoot Biomedical today announced an agreement with Pittsburgh-based Allegheny Health Network (AHN) to further develop Bigfoot’s Unity investigational insulin delivery wireless platform. The diabetes startup described Unity as a first-in-kind, data-driven solution for optimizing insulin dosing and delivery. Bigfoot will work alongside AHN endocrinologists and primary care doctors to refine Unity’s clinical workflow features. “We understand […]
AxoSim touts results of nerve-on-a-chip study
A new study of AxoSim’s Nerve-on-a-Chip technology shows that the platform accurately provides key physiological readouts that could help speed the development of drugs to treat neurological disorders. The study also shows that Nerve-on-a-Chip technology is the first all-human in vitro model that can measure critical factors that were formerly only available using live animal models. […]
Clearside Biomedical licenses microinjector to Aura Biosciences
Clearside Biomedical (NSDQ:CLSD) said today that it licensed its microinjector technology to Aura Biosciences for use with Aura drug candidates in treating ocular cancers. Alpharetta, Ga.-based Clearside’s Suprachoroidal Space Microinjector is designed to deliver therapeutics into the suprachoroidal space between the sclera and choroid of the eye. Aura, based in Cambridge, Mass., is developing viral nanoparticle […]
Valeritas touts study results
Valeritas (NSDQ:VLRX) today announced the results of a study that showed patients using its V-Go wearable insulin delivery device needed less insulin, had lower A1c levels and reduced diabetes-related medication cost compared with patients using multiple daily injection (MDI) therapy. The retrospective study by the Bridgewater, N.J.-based company used information from the HealthCore Integrated Research Database […]
Abbott touts real-world CGM data at diabetes conference
Abbott (NYSE:ABT) said today that new data show its FreeStyle Libre continuous glucose monitoring (CGM) system significantly reduces hemoglobin A1c (HbA1c) levels in certain adults with type 2 diabetes. Presented as a late-breaker at American Diabetes Association (ADA) annual conference in San Francisco, the data represent what Abbott termed the first evaluation of real-world evidence from […]
