A Boston Scientific (NYSE:BSX) device coated with less of the controversial drug paclitaxel than one made by Medtronic (NYSE:MDT) is just as safe and effective for patients with peripheral artery disease (PAD), according to a study published this … [Read More...]
Sponsored Content
Are You Prepared for the Upcoming Blanket No Change Certification Reporting Period? Learn more from Reed Tech
Listen to the recording of Reed Tech’s ‘Blanket No Change Certification webinar’ to learn about annual No Change Certification submission requirements for drug product listings and what steps are … [Read More...]
Featured Posts
DHS warns on Insulet Omnipod
The U.S. Dept. of Homeland Security (DHS) issued a medical advisory to warn of vulnerabilities with the Insulet (NSDQ:PODD) Omnipod insulin management system. According to the advisory, the affected insulin pumps are designed to communicate using … [Read More...]
Nemaura Medical enters non-binding agreements for its SugarBeat platform
Nemaura Medical (NSDQ:NMRD) announced today that it entered into multiple verbal non-binding agreements for its SugarBeat continuous glucose monitor as it seeks to secure regional and global partnerships. The Loughborough, U.K.–based company … [Read More...]
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 … [Read More...]
Insulet down after hours on Q4 sales beat, bottom-line slide
Insulet (NSDQ:PODD) shares sunk after hours today on fourth-quarter results that beat the consensus forecast for revenue but appeared to miss on earnings. The Acton, Mass.–based insulin delivery device maker posted profits of $5 million, or 8¢ per … [Read More...]
BD warns on some ambulatory syringe pumps
Becton Dickinson (NYSE:BDX) issued a field safety notice in the United Kingdom to warn on an issue with its T34 and T34L (T60) ambulatory syringe pumps. The company was alerted to an issue with the syringe pumps that could cause risk of … [Read More...]
Insulet partners with Abbott and Dexcom on automated insulin delivery
Abbott (NYSE:ABT) and Dexcom (NSDQ:DXCM) each announced today that they are partnering with Insulet (NSDQ:PODD) to feed blood glucose monitor data into an automated insulin delivery system. For Acton, Mass.–based Insulet, the agreements are a … [Read More...]
These ‘smart’ bandages could heal chronic wounds
UConn biomedical engineers are touting a wirelessly controlled "smart" bandage and corresponding platform for delivering medications to chronic, non-healing wounds. UConn's School of Dental Medicine, School of Medicine and School of Engineering … [Read More...]
Could this handheld 3D bioink printer improve wound healing?
The University of Toronto is touting a new handheld 3D printer that is capable of depositing sheets of skin to cover burn wounds and accelerate the healing process. A study, led by Richard Cheng under the supervision of Axel Guenther, published in … [Read More...]
Insulet’s Omnipod Dash Personal Diabetes Managers have a glitch
Insulet (NSDQ:PODD) is issuing a voluntary medical device correction for all of the smartphone-like Personal Diabetes Managers that came with its next-gen Omnipod Dash insulin management system, the company announced today. During its ongoing … [Read More...]
Wearable insulin delivery device maker Valeritas files for Chapter 11, selling company
Valeritas (NSDQ:VLRX) announced that the company and its subsidiaries filed voluntary petitions for Chapter 11 bankruptcy, having agreed to sell substantially all of the business to Zealand Pharma (CPH:ZEAL). The agreement is slated to provide a … [Read More...]
In case you missed it
- FDA says Medtronic MiniMed insulin pump recall is serious
- Senseonics, Companion Medical to integrate sensor glucose and insulin data
- Contura wins FDA premarket approval for hydrogel injection
- Teleflex recalls certain Arrow epidural catheterization kits in Europe
- Rani Therapeutics could go the IPO route
- Study: High- and low-dose drug-coated balloons equally effective in PAD
- Vascular Therapies closes $17.3m financing
- Smith & Nephew acquires Tusker Medical
- Medtronic launches data management software program for Synchromed II
- Tandem Diabetes Care launches t:slim X2 with Control-IQ in U.S.
- Abbott boosts support for Bigfoot Biomedical and its diabetes treatment tech
- 7 medtech advances to improve diabetes treatment
- Phillips-Medisize expands Denmark site
- Dyve Biosciences hires new chief scientific officer
- Medinol stent performs just as well as Medtronic Resolute, study says
Clinical Trials
Study: High- and low-dose drug-coated balloons equally effective in PAD
A Boston Scientific (NYSE:BSX) device coated with less of the controversial drug paclitaxel than one made by Medtronic (NYSE:MDT) is just as safe and effective for patients with peripheral artery disease (PAD), according to a study published this week. The prospective, randomized controlled trial compared the lower-dose (2 μg/mm2 of paclitaxel) Boston Scientific Ranger drug-coated […]
Medinol stent performs just as well as Medtronic Resolute, study says
The EluNIR drug-eluting stent made by Medinol performed just as well as the Resolute Integrity or Resolute Onyx stents from Medtronic (NYSE:MDT), according to new clinical study results from an international team of researchers. The randomized clinical trial — conducted by researchers from the U.S., Israel, Canada and the Netherlands — involved 2,221 people and compared […]
NIH study: Tandem Diabetes artificial pancreas bests other treatments
A pivotal trial funded by the National Institutes of Health found that an artificial pancreas system from Tandem Diabetes Care (NSDQ:TNDM) was more effective than existing treatments for people with Type 1 diabetes. The Tandem system combines its t:slim X2 insulin pump and Control-IQ advanced hybrid closed-loop technology with a continuous glucose monitor made by DXCM, […]
Frequency Therapeutics launches hearing loss trial, gains the fast track at FDA
Frequency Therapeutics (NSDQ:FREQ) said today that it launched a Phase 2a study and won fast-track designation at the FDA for its regenerative hearing loss drug. The fast-track program aims to speed up the approval of therapies for unmet needs in serious conditions. Woburn, Mass.-based Frequency’s FX-322 candidate is designed to stimulate the regrowth of sensory hair cells […]
Intersect ENT’s Ascend study misses endpoint
Intersect ENT (NSDQ:XENT) shares plunged today after the company said it failed to meet the primary endpoint in a study of its Ascend investigational drug-coated sinus balloon. The 70-person, randomized, double-blind trial was designed to compared treatment with Intersect ENT’s DCB when randomized against an uncoated balloon control. The study missed the primary endpoint, frontal sinus […]
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