Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


Clinical Trials

Set Alert for Clinical Trials

Boston Scientific Puts Charge In Neuromodulation Business By Acquiring Relievant

Relievant’s Intracept intraosseous nerve ablation system is the only FDA-cleared neuromodulation device indicated to treat vertebrogenic pain. Boston Scientific will pay $850m for Relievant, plus undisclosed milestone payments over the next three years.

M & A Neurology

New FDA Documents On Weight-Loss Devices, Software And International Harmonization As End Of Fiscal Year Nears

With the end of fiscal 2023 just over a week away, the US Food and Drug Administration has been publishing promised guidance documents, action plans and white papers.  Medtech Insight’s round-up of four device-specific documents is below.

Guidance Documents FDA

Medtech DEI Experts Talk Shop: ‘It’s Going To Transform Businesses’

An all-female panel of medtech DEI leaders at the LSX Congress USA conference discussed the importance of diversity and inclusion in research, clinical trials, product development and services to advance health equity as well as fundamental business goals.

Diversity & Inclusion Business Strategies

Are GLP-1 Major Threat To The Insulin Delivery Tech Market?

A small scale study has indicated that GLP-1 agonists could restore normal HbA1c levels in type I diabetics. This therapy could be a huge step forward for the treatment of this chronic disease if this benefit is shown in larger studies.

Diabetic Care Metabolic

Minute Insight: Mainz Biomed Shows Off New Colorectal Cancer Diagnostic Test Data

The company’s ColoAlert mRNA-based diagnostic has proven similarly efficacious to colonoscopy, while outperforming competing blood/stool-based diagnostics.

Diagnostics Cancer

News We’re Watching: Philips And Walgreens Settlements, ReCor Readies For Takeoff, Farapulse Trial Results

This week, Philips announced a legal settlement on recalled CPAPs and BiPAPs; the FDA released emergency preparation recommendations; ReCor prepared to bring Paradise RDN to the US market; and Abbott released the results of a trial comparing optical coherence tomography (OCT) to angiography for guidance during cardiac surgery.

Clinical Trials Commercial

Click Therapeutics And Indivior Collaborate On Prescription Digital Therapeutics In Substance Use Disorder

Click Therapeutics and Indivior will develop a digital solution for treating substance use disorders, starting with opioid use disorders. Click already signed partnership deals with Otsuka and Verily and Boehringer Mannheim to co-develop digital therapeutics for patients with schizophrenia and major depressive disorder.

Artificial Intelligence Behavioral Health

EU Project To Evaluate Delays To Drug Trials Conducted Alongside Studies For IVDs/Devices

The European Commission is steering a new member state-driven project that aims to get to the bottom of factors causing delays to trials that simultaneously investigate a drug product with an IVD or a medical device, and propose some solutions.

Europe Clinical Trials

News We’re Watching: ICD Trial Success, EOFlow Restraining Order, Hamilton Ventilator Recall

This week, Medtronic presented data from two new real-world trials confirming that ICDs save lives; a restraining order was issued against EOFlow in Insulet’s intellectual property case; and Polarean’s MRI gas XENOVIEW received a new Medicare reimbursement code.  

Commercial Clinical Trials

MDR Up-Classification Of Some Spinal Fusion Devices ‘Unwarranted’ Says Expert Group

A change in risk classification for some legacy spinal fusion devices under the new EU MDR means that certain products face stricter clinical evidence requirements, which expert group OSMA told Medtech Insight is “unnecessary” and “overly-burdensome” for manufacturers.

Medical Device Orthopedics

Cardio Catch-Up: Advisory Panel Gives Recor Momentum Toward US Launch Of RDN System

The majority of FDA’s circulatory systems devices panel agreed that ReCor’s Paradise ultrasound renal denervation system offers a safe and effective therapy for patients with hypertension. The panel’s endorsement means ReCor will likely be the first company to reach the US market with an RDN system.

Advisory Committees Clinical Trials

Cardio Catch-Up: Medtronic Still Has Work To Do On RDN After FDA Advisory Panel

FDA’s circulatory system advisory panel narrowly voted against Medtronic’s Symplicity Spyral, because one of the pivotal trials of the radiofrequency renal denervation system missed its primary endpoint and the patient population evaluated in the trial does not match the requested indication.

Advisory Committees Approvals

News We’re Watching: Califf Talks ORA Reorg, Contaminants Bring Ventilator Recall, 27-Year Sentence On Medicare Fraud

This week, FDA Commissioner Robert Califf described plans for restructuring the Office of Regulatory Affairs; Studies found chatbots don’t give trustworthy advice to cancer patients; and the owner of an Atlanta genetic testing lab was sentenced to 27 years in prison over a massive Medicare fraud scheme.  

Regulation Approvals

Regulatory And Commercial Should Be 'Hand In Hand' For Dx Success, Expert Says

Considering where and how a test will be used, and what kind of evidence regulators will want before clearing it, is key for developers of at home and point-of-care diagnostics.

Clinical Trials Regulation

‘Significant Changes’ To Research Ethics Review Rules In Australia Include New Risk Model

Researchers, research offices and ethics committees are being encouraged to familiarize themselves with the new National Statement on Ethical Conduct in Human Research before it becomes applicable on 1 January 2024.

Australia Clinical Trials

News We’re Watching: ReCor And Medtronic Head To RND Panel, Clearances For Anika And Sequel, ZimVie And Brainlab Partner

This week, the US FDA geared up for a renal denervation panel meeting; a microbiology panel meeting was announced; and a hyaluronic acid patch to promote rotator cuff healing, a novel spiral tampon, and a tibial neuromodulation device to treat incontinence all won FDA clearance. 

Approvals Advisory Committees
See All