U.K. medtech regulators have recommended a ban on routine use of paclitaxel drug-coated balloons (DCBs) and drug-eluting stents in patients with intermittent leg cramps, but held back on recommending the same for patients with critical limb ischemia. U.S., U.K. and French regulators began raising concerns about the risk of increased long-term mortality in people with […]
Beta Bionics starts new trial for bionic pancreas
Boston-based Beta Bionics said this week that the first patients have begun home use of dasiglucagon in a clinical trial of the company’s iLet bionic pancreas system for people with Type 1 diabetes. The iLet device features an autonomous, dual-chamber infusion pump that is powered by dosing algorithms. Using machine learning and data from a continuous […]
Senseonics slides on Q1 loss, maintains outlook for 2019
Shares in Senseonics (NYSE:SENS) fell today after the diabetes-focused device maker posted first-quarter results that missed the consensus forecast on Wall Street. The Germantown, Md.-based company cited positive early feedback on the March launch of its Eversense Bridge Program, which is designed to improve patient access to the company’s Eversense continuous glucose monitoring system. Senseonics […]
Louisiana prisoners may get non-FDA-approved naltrexone implant
This article has been updated to clarify the BioCorRx’s role in the program. The Louisiana Department of Corrections is working with BioCorRx (OTC:BICX) to offer soon-to-be-released inmates an opioid addiction treatment implant that has not been approved by the FDA. The implant, which contains a compounded form of naltrexone, is one of several medication-assisted options being […]
Intersect ENT wins preliminary CMS reimbursement code
Shares in Intersect ENT (NSDQ:XENT) got a boost yesterday on news that the Centers for Medicare and Medicaid Services (CMS) had assigned the company’s Sinuva corticosteroid-eluting sinus implant a preliminary J-code. Intersect ENT stock, which had been bumping along just under $30 per share last week, jumped to $33.13 per share at Monday’s market open, […]
Phillips-Medisize Arkansas plant expands medtech capacity
Phillips-Medisize said today that it now has FDA-compliant manufacturing space in the Little Rock, Ark. plant of its parent company, Molex. The 380,000-square-foot facility is now fully compliant with the Current Good Manufacturing Practice (CGMP) regulations (21 CFR part 820) enforced by the FDA. The plant can now be used for Phillips-Medisize’s medical manufacturing services, including […]
FDA nixes Evoke Pharma’s gastro nasal spray
The FDA has rejected Evoke Pharma’s (NSDQ:EVOK) application for a metoclopramide nasal spray for diabetic women with gastroparesis. The Solana Beach, Calif. company’s stock price tumbled 40% on the news yesterday that the agency had found dosing inconsistencies in the pivotal pharmacokinetic study for the spray, Gimoti. In an earlier multi-disciplinary letter to the company, […]
Cigna lowers insulin price to $25 per month
Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients. Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. […]
PolarityTE launches two chronic wound treatment trials
PolarityTE (NSDQ:PTE) said it has begun enrolling patients in two new randomized clinical trials of its SkinTE regenerative tissue product for chronic wounds. The trials will evaluate the SkinTE’s effectiveness in treating diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). SkinTE is a human cellular and tissue-based product designed to regenerate full-thickness, functional skin […]
West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug
scPharmaceuticals’ (NSDQ:SCPH) has signed a development agreement to incorporate West Pharmaceutical Services’ (NYSE:WST) SmartDose drug delivery system with Furoscix, a drug that scPharmaceuticals developed to treat edema in heart failure patients. Burlington, Mass.-based scPharmaceuticals recently completed preliminary feasibility studies of the drug-device combination. The testing included drug stability in the pre-filled cartridge, drug compatibility, and […]
