Concept Medical said yesterday that it received CE Mark approval for three versions of its MagicTouch sirolimus-coated balloons. The MagicTouch PTA for peripheral artery disease, MagicTouch ED for erectile dysfunction and MagicTouch AVF for arterio-venous fistula and graft all received approval in Europe, according to a news release. Concept Medical said MagicTouch PTA is the […]
Novartis unit spikes Pear Therapeutics deal
Novartis (NYSE:NVS) unit Sandoz said this week that Pear Therapeutics will take sole responsibility for the commercialization of their prescription digital therapeutics program for treating substance and opioid use disorders. In April 2018, Pear announced that it agreed to deal commercialization rights of its digital therapeutics to Sandoz. The companies did not disclose financial details, but […]
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, […]
Gates Foundation backs Credence MedSystem’s drug-delivery device
Credence MedSystems said yesterday that it won a grant from the Bill & Melinda Gates Foundation for the development of its Companion dual-chamber reconstitution syringe for use in developing nations. The development project is meant to advance the safety of the Companion device for drug and vaccine products, which include storing drugs in dried form […]
Senseonics touts Eversense reimbursement win
Senseonics (NYSE:SENS) said this week that Health Care Service Corporation – Blue Cross Blue Shield is providing coverage for the Eversense continuous glucose monitoring system, effective as of yesterday. HCSC – Blue Cross Blue Shield is the fourth-largest health insurer in the U.S. and serves more than 16 million members, according to a news release. Last […]
FDA approves Philips’ low-dose Stellarex balloons
Royal Philips (NYSE:PHG) said today that two of the company’s new Stellarex drug-coated balloons received FDA approval for the treatment of upper leg artery blockages. The approval was for both de novo and restenotic lesions in upper leg arteries. The Amsterdam-based company said the new low-dose (200 mm and 150 mm) balloons will be added to […]
Intarcia Therapeutics takes another run at FDA approval
Intarcia Therapeutics said last week that the FDA accepted its new drug application resubmission for ITCA 650 for the treatment of Type 2 diabetes mellitus. The Boston-based company originally resubmitted the NDA on Sept. 9. FDA told the company that it considered the NDA resubmission a complete class 2 response. The Prescription Drug User Fee […]
Abbott inks inks diabetes tech partnerships with Tandem Diabetes, Omada Health
Abbott (NYSE:ABT) said today that it has entered into an agreement with Tandem Diabetes Care (NSDQ:TNDM) to combine the former’s glucose-sensing technology with the latter’s insulin delivery systems. The news comes one day after Abbott announced a partnership with Omada Health to pair Abbott’s FreeStyle Libre continuous glucose monitoring system with Omada’s digital care program. Tandem designed its […]
OcuMedic, Gelest ink drug-delivering contact lens deal
OcuMedic said today that it entered into an exclusive supply agreement and picked up a strategic investment from Gelest for its proprietary drug-eluting soft contact lens of an undisclosed amount. Under the terms of the agreement, Morrisville, Pa.-based Gelest is set to manufacture and supply OcuMedic’s key chemistry components used in the controlled release of […]
BioCardia wins CE Mark renewal for Helix, Morph catheters
BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]
