Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Clinical Trials

Set Alert for Clinical Trials

SENSE Results Support Biotronik’s DX System For Atrial Sensing Without An Atrial Lead

Results of the SENSE trial showed Biotronik’s DX system, which is available in both ICD and CRT-D devices, can detect atrial high-rate episodes as effectively as dual-chamber ICDs and better than single-chamber ICDs even though it does not have an atrial sensing lead.

Clinical Trials Research & Development Innovation
Advertisement

Latest From Clinical Trials

Stanford Launches Trial Of NeuroPace’s Responsive Neuromodulation To Stop Overeating

The DBSLOC trial will study the feasibility of using NeuroPace’s RNS responsive neuromodulation system to stimulate the nucleus accumbens in order to stop “loss-of-control” eating in people with treatment-refractory obesity, especially those who have failed to respond adequately to gastric bypass surgery.

Clinical Trials Innovation

EU To Join Countries Covered By India’s Clinical Investigation Waiver Rule

Indian regulators intend to waive their clinical investigation requirements for certain medical devices that are already approved in the EU.

Clinical Trials India

FDA Approves CVRx’s Barostim Neo For Heart Failure On Expedited Pathway

The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.

Approvals Clinical Trials

FDA Expands TAVR Indication To Low-Risk Patients

As expected, the US FDA has expanded the approved indication for four transcatheter aortic valves – Edwards Lifescience’s Sapien 3 and Sapien 3 Ultra, and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO – to include patients at low risk for complications during surgery.

Approvals Clinical Trials

Regulators Urged To Avoid ‘Conflicting’ Clinical Requirements For Drug-Device Combinations In EU

EU regulators are being urged to get their skates on and publish guidance on new clinical requirements that will kick in soon for integral drug-device combination products.

Clinical Trials Combination Products

Top FDAer Skeptical Of Wearable Devices, Says Agency Is Working To Improve Standards And Technology

Amy Abernethy, the principal deputy commissioner at the US FDA, told attendees at a 25 July medical conference that she's somewhat skeptical about using wearable technologies for clinical needs because they still haven’t proven their accuracy. However, she says the device center is working hard to develop new standards for such products and is looking for funding to develop them.

Regulation Digital Health

CMS Clarifies Criterion To Evaluate New Tech Add-On Payments In Inpatient Rule

The US Medicare agency revised and clarified its policies on how it evaluates new technology add-on payments and highlighted its new policy on payments for FDA-approved breakthrough devices, in a final 2020 Inpatient Prospective Payment System (IPPS) rule released on 5 August.

Reimbursement Medicare

FDA Announces More Actions On Drug-Coated Devices

The US FDA’s latest update on the safety of paclitaxel-coated balloons and stents urges additional clinical trials. The agency also plans updates to device labeling and clinical trial informed consent documents that will reflect evidence that the devices may pose a mortality risk.

Safety Regulation

QUOTED. 7 August 2019. Andrew Newland.

UK-based liquid biopsy company Angle PLC is expecting to make a landmark regulatory submission to the US Food and Drug Administration early in the fourth quarter of 2019 for Parsortix, which aims to detect and capture circulating tumor cells in cancer patients. See what Angle's CEO, Andrew Newland, said about it here.

Quoted Clinical Trials
See All
UsernamePublicRestriction

Register