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Clinical Trials

FDA lifts hold on Vertex’s insulin-producing cell therapy for diabetes

July 5, 2022 By Sean Whooley

Vertex Pharmaceuticals

Vertex Pharmaceuticals (Nasdaq:VRTX) announced today that the FDA lifted the clinical hold placed on the Phase 1/2 trial of VX-880. Boston-based Vertex designed VX-880 as a stem cell-derived fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemia. It could potentially restore the body’s ability […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Vertex Pharmaceuticals

GlucoTrack provides positive update on next-gen glucose monitor

June 22, 2022 By Sean Whooley

GlucoTrack

GlucoTrack (Nasdaq:GCTK) announced today that its second-generation glucose monitor device has shown promising results in analyses. Rutherford, New Jersey-based GlucoTrack — formerly known as Integrity Applications (Nasdaq:IGAP) — earlier this year completed lab testing of the non-invasive GlucoTrack 2.0 clinical prototype system and has observed better-than-expected accuracy and performance with the technology. According to a […]

Filed Under: Business/Financial News, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring Tagged With: Glucotrack, integrityapplications

GI Dynamics EndoBarrier meets endpoints in diabetes, obesity study

June 15, 2022 By Sean Whooley

GI Dynamics Logo

GI Dynamics today announced the results of a study of its EndoBarrier system that met efficacy and safety endpoints. Boston-based GI Dynamics designed its EndoBarrier endoscopically delivered device therapy as a non-surgical, alternative treatment for type 2 diabetes and obesity for patients who do not have adequate control of their conditions through their current medication and […]

Filed Under: Clinical Trials, Diabetes Tagged With: GI Dynamics

Data shows cost benefits with Pear Therapeutics digital therapeutic for opioid use disorder

June 14, 2022 By Sean Whooley

Pear Therapeutics

Pear Therapeutics (Nasdaq:PEAR) today shared real-world data highlighting low costs with its reSET-O prescription digital therapeutic (PDT). Boston-based Pear Therapeutics’ reSET-O represents the only FDA-authorized PDT for the treatment of opioid use disorder (OUD). According to a news release, results from a 12-month, real-world data study of reSET-O demonstrated reduced healthcare resource utilization and associated […]

Filed Under: Big Data, Business/Financial News, Clinical Trials, Drug-Device Combinations, Featured, Neurological, Patient Monitoring Tagged With: Pear Therapeutics

Early study supports experimental hydrogel injection for chronic low back pain

June 13, 2022 By Sean Whooley

ReGelTec Hydrafil System Hydrogel

A study demonstrated that an experimental hydrogel formulation was safe and effective in substantially relieving chronic low back pain. Research presented at the Society of Interventional Radiology Annual Scientific Meeting in Boston supported the hydrogel, which was injected into spinal discs in an effort to relieve chronic low back pain caused by degenerative disc disease […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Hydrogels, Orthopedics, Pain Management Tagged With: hydrogels, ReGelTec

Data supports Beta Bionics’ iLet bionic pancreas

June 9, 2022 By Sean Whooley

Beta Bionics - updated logo

Beta Bionics announced today that a trial of its iLet bionic pancreas met key endpoints, including reduced HbA1c. Dr. Roy W. Beck and clinical investigators presented the results of the multi-center, randomized Insulin-Only Bionic Pancreas Pivotal Trial (IO BPPT) at the American Diabetes Association (ADA) 82nd Scientific Sessions in New Orleans. Read: The biggest stories […]

Filed Under: Auto-injectors, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: Beta Bionics

Pear Therapeutics reports positive real-world data for chronic insomnia treatment

June 8, 2022 By Sean Whooley

Pear Therapeutics

Pear Therapeutics (Nasdaq:PEAR) today announced real-world data from a trial of its Somryst prescription digital therapeutic (PDT). Data showed that Somryst, the only FDA-authorized PDT for treating chronic insomnia, achieved significant reductions in symptoms of insomnia, anxiety and depression severity both immediately following treatment and at six-months follow-up. Boston-based Pear Therapeutics presented results at the […]

Filed Under: Clinical Trials, Neurological, Technology Tagged With: Pear Therapeutics

First patient enrolled in MedAlliance’s drug-eluting balloon trial

June 8, 2022 By Sean Whooley

MedAlliance SELUTION SLR

MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon. Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA), Vascular Tagged With: MedAlliance

The biggest stories from the American Diabetes Association (ADA) 2022 Scientific Sessions

June 8, 2022 By Sean Whooley

American Diabetes Association Abbott FreeStyle Libre 3 Dexcom G7 Insulet Omnipod 5 Medtronic MiniMed 780G

For the 82nd time, the American Diabetes Association (ADA) Scientific Sessions convened to highlight all the innovations within the diabetes technology space. Major players like Dexcom, Medtronic, Abbott, Insulet and more continue to plug along, while companies like Bigfoot Biomedical, One Drop and others shared data backing the technology that they bring to the table. […]

Filed Under: Auto-injectors, Business/Financial News, Clinical Trials, Diabetes, Drug-Device Combinations, Featured, Patient Monitoring, Technology Tagged With: abbott, American Diabetes Association, Bigfoot Biomedical, dariohealth, Dexcom, Insulet, Medtronic, One Drop, Tandem Diabetes Care, Virta Health

Sernova touts data on implantable cell pouch for treating insulin-dependent diabetes

June 7, 2022 By Sean Whooley

Sernova Cell Pouch System

Sernova announced clinical data supporting the potential of its Cell Pouch system as a “functional cure” for insulin-dependent diabetes. London, Ontario-based Sernova designed its proprietary Cell Pouch system as an implantable and scalable medical device that forms a natural environment in the body for long-term survival and function of therapeutic cells that release necessary proteins […]

Filed Under: Clinical Trials, Diabetes, Drug-Device Combinations Tagged With: Sernova Inc

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