Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome (PRO) instruments for device evaluation. However, the draft is sufficiently vague on the question of when an existing PRO can be tweaked without an entirely new validation study to prompt the Advanced Medical Technology Association (Advamed) to press the agency for more clarity on that point.
The PMA for the Neovasc Reducer device for treatment of drug-refractory angina faltered at an Oct. 27 U.S. FDA advisory committee, but it wasn’t for lack of support from star-power cardiologists. Gregg Stone, of the Cardiovascular Research Foundation, gave an impassioned plea for approval, pointing out that these patients have few options if they are poor candidates for bypass grafting or percutaneous coronary intervention. Stone said, “this is really a desperate patient cohort,” adding that a two-class improvement in angina severity “is a robust reduction.”
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Advisory hearing gives Neovasc Reducer poor marks for efficacy; CMS eyes expanded DME coverage of CGMs; APEC launches Vision 2025 for business ethics; Innovation Alliance voices support for Iancu, PTAB changes.
The past two device user fee schedules have essentially doubled the volumes collected in the prior fee agreements, a pace that some in industry have described as unsustainable. That issue was front and center again in the first public meeting for the next user fee agreement, with FDA commissioner Stephen Hahn saying the agency’s device center needs more money, and industry representatives arguing that the bulk of the device center’s funding must be obtained through congressional appropriations, not from industry-funded user fees.
The U.S. FDA moved the goal posts for other companies with its expansion of the emergency use authorization for Helix Opco LLC’s COVID-19 test to include both unsupervised self-collection of samples and testing of asymptomatic individuals. The new indications promise to make the Helix test the preferred tool for schools, universities, and work settings by reducing costs and increasing flexibility.
Virtual Incision Corp. revealed that it had received a green light from the U.S. FDA to begin its study of its miniaturized in vivo robotic assistant (MIRA) Platform. Initially, the company will focus the platform on minimally invasive laparoscopic colon surgery. With the MIRA Platform, the company will aim to enter a growing market in the U.S., where more than 400,000 colon resection procedures are performed each year.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS provides details of Binax test distribution.
Premarket approval by the U.S. FDA of a new venous stent system made by Medtronic plc could blast through impediments for patients who suffer from complex deep vein obstruction. Less than 1% of patients with iliofemoral venous outflow obstruction currently receive treatment, despite the risk of serious complications and sharply reduced quality of life. Approval of the Abre stent was based on a 200-patient clinical study.
The U.S. FDA draft guidance for select updates for premarket evaluation of class II atherectomy devices arrived with a lack of clarity that prompted device makers and clinicians alike to request the FDA address several sources of ambiguity. One of these is whether the agency should distinguish between particulate matter from the device vs. calcium particulates from the treated artery, while another is whether particulate evaluation is required only for devices with a coating.
Abiomed Inc. has won the U.S. FDA’s nod for its Breethe Oxy-1 device, an all-in-one, compact cardiopulmonary bypass system designed for easy mobility. The company plans a controlled release at U.S. hospitals between now and March of 2021, with widespread availability later that year.
RSS
