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
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...]
FDA says Medtronic MiniMed insulin pump recall is serious
The U.S. FDA has designated a recall of hundreds of thousands of Medtronic Minimed insulin pumps as Class I — the most serious type of recall. Medtronic (NYSE:MDT) first warned of safety problems with the pumps in November. The recall involves … [Read More...]
Senseonics, Companion Medical to integrate sensor glucose and insulin data
Senseonics (NYSE:SENS) will integrate its Eversense continuous glucose monitoring (CGM) system's real-time glucose data with Companion Medical's InPen smart insulin delivery system. The agreement between Senseonics and Companion, announced today, … [Read More...]
Contura wins FDA premarket approval for hydrogel injection
Contura announced that it won FDA premarket approval for its Bulkamid hydrogel injection for treating stress urinary incontinence (SUI). Bulkamid is Contura's proprietary device designed for treating SUI due to intrinsic sphincter deficiency in … [Read More...]
Teleflex recalls certain Arrow epidural catheterization kits in Europe
Teleflex (NYSE:TFX) subsidiary Arrow issued an urgent field safety notice in Europe to warn of failures with the loss of resistance (LOR) syringes including in epidural catheterization kits. The company received complaints regarding the syringes … [Read More...]
Rani Therapeutics could go the IPO route
Rani Therapeutics is reportedly moving forward with an early-stage efficacy and safety study for its robotic pills and may be on its way toward the possibility of an IPO. According to a report in Endpoints News, Rani, led by CEO Mir Imran who … [Read More...]
In case you missed it
- 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
- Indiana man may proceed with pain pump lawsuit against Medtronic
- CF PharmTech raises $90m
- FDA wants feedback on combination products guidance
- Delcath Systems announces reverse stock split
- Smiths Medical recalls Medfusion 4000 due to issue with software update
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 […]
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn