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Research & Development

Tusker Medical’s pediatric ear tubes land breakthrough device designation

November 26, 2019 By Nancy Crotti

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 […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pediatrics, Research & Development Tagged With: FDA, Tusker Medical

Cook Regentec launches blood filtration trial for critical limb ischemia

September 11, 2019 By Nancy Crotti

Cook Medical - updated logo

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 […]

Filed Under: Clinical Trials, Featured, Research & Development, Uncategorized, Vascular Tagged With: cook medical, Cook Regentec

Frequency Therapeutics registers $100m IPO

September 9, 2019 By Sean Whooley

Frequency Therapeutics updated logo

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 […]

Filed Under: Business/Financial News, Featured, Funding Roundup, Hydrogels, Initial Public Offering (IPO), Otolaryngology Ear, Nose & Throat, Research & Development, Stem Cells Tagged With: Frequency Therapeutics

Medtronic’s In.Pact AV DCB meets endpoints in trial

September 9, 2019 By Sean Whooley

Medtronic logo updated

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 […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Research & Development, Vascular Tagged With: Medtronic

FDA wants more study of paclitaxel-eluting devices’ long-term safety

August 8, 2019 By Nancy Crotti

FDA-logo-new

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 […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Research & Development, Uncategorized, Vascular Tagged With: FDA

Bigfoot Biomedical inks deal with Pittsburgh health system

August 1, 2019 By Nancy Crotti

Bigfoot Biomedical updated logo

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 […]

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Research & Development, Uncategorized Tagged With: Allegheny Health Network, Bigfoot Biomedical

AxoSim touts results of nerve-on-a-chip study

July 9, 2019 By Nancy Crotti

AxoSim

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. […]

Filed Under: Featured, Neurological, Research & Development, Stem Cells Tagged With: AxoSim

Clearside Biomedical licenses microinjector to Aura Biosciences

July 9, 2019 By Brad Perriello

Clearside Biomedical, 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 […]

Filed Under: Drug-Device Combinations, Featured, Optical/Ophthalmic, Research & Development Tagged With: Aura Biosciences, Clearside Biomedical

Valeritas touts study results

July 8, 2019 By Nancy Crotti

Valeritas V-Go device - updated

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 […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Research & Development, Uncategorized, Wall Street Beat Tagged With: Valeritas Inc.

Abbott touts real-world CGM data at diabetes conference

June 8, 2019 By Nancy Crotti

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 […]

Filed Under: Clinical Trials, Diabetes, Featured, Food & Drug Administration (FDA), Research & Development, Uncategorized Tagged With: abbott, American Diabetes Association, FDA

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