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Final Chance To Have Your Say: Take Our Reader Survey This Week

Ryan Nelson — Tue, 17 Sep 2024 22:26:49 +0000

We value your feedback and suggestions as we look to improve the format of our content and the way it is delivered to you. By completing our customer survey , you can provide your input on essentia

Shape Our Content: Take The Reader Survey

Ryan Nelson — Wed, 04 Sep 2024 10:20:50 +0000

We value your feedback and suggestions as we look to improve Medtech Insight and the way it is delivered to you. By completing our customer survey , you can provide your input on essential aspects

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

Marion Webb — Thu, 22 Aug 2024 19:23:31 +0000

Just one week after receiving US Food and Drug Administration approval to provide deep brain stimulation (DBS) surgery while patients are under general anesthesia, Medtronic plc announced the agency

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

Natasha Barrow — Tue, 09 Jul 2024 12:00:00 +0000

Open Media

‘If It Wasn’t For NeuroStar, I Wouldn’t Be Here Today,’ Says Teen Patient

Brian Bossetta — Thu, 16 May 2024 19:37:42 +0000

Medtech Insight is honoring May and June awareness months for mental health, Alzheimer’s and brain health by speaking with industry leaders about rising innovations to address neurological diseases an

For Women In Medtech Emotions Can Come At A Cost

Barnaby Pickering — Wed, 06 Mar 2024 16:41:10 +0000

Friday, 8 March is International Women’s Day. To celebrate the day and Women’s History Month, Medtech Insight spoke with female leaders in medtech, regulatory and health care delivery about their ex

Publisher’s Spotlight: Citeline News And Insights App

Medtech Insight Team — Mon, 04 Mar 2024 17:37:13 +0000

Enjoy a faster, streamlined experience, tailor-made for your mobile device – now available on the App Store and Google Play . Effortlessly switch between publications, customize your home screen, a

Canary Speech’s Voice AI Can Help Detect Alzheimer’s With 40-Second Conversation

Marion Webb — Fri, 23 Feb 2024 17:10:03 +0000

Just as canaries once were used in coal mines to detect life-threatening levels of toxic gases before they sickened miners, Canary Speech is using vocal biomarkers to identify “previously silent healt

Q&A: Jeffrey Shapiro Talks Device Approval Strategy And More

Elizabeth Orr — Wed, 30 Aug 2023 22:40:36 +0000

Leading device attorney Jeffrey Shapiro has spent more than 25 years representing large, small and in-between manufacturers in their dealings with the US Food and Drug Administration. A graduate of Br

Minute Insight: CareDx Enters Donor Organ Procurement Market With MediGO Acquisition

Reed Miller — Tue, 25 Jul 2023 19:40:53 +0000

CareDx , a developer of products and services specifically for organ transplant, acquired MediGo, an organ-transplant supply chain and logistics company. Terms of the deal announced on 25 July were no

Renalytix’s De Novo Authorization For KidneyIntelX.dkd Paves Way To Other Markets, Channels

Marion Webb — Thu, 06 Jul 2023 23:30:08 +0000

After a long wait, Renalytix AI plc was finally granted de novo authorization from the US Food and Drug Administration for its AI-powered prognostic blood test, KidneyIntelX.dkd, which identifies e

Abbott Expects Assert-IQ To Change Arrhythmia Monitoring

Reed Miller — Thu, 15 Jun 2023 20:58:07 +0000

Abbott expects its new Assert-IQ insertable cardiac monitor (ICM) to improve remote arrhythmia management and complement its successful CardioMEMS implantable pressure sensor. “Assert-IQ revolutioniz

Brazilian Medtechs Leave Gloomy 2021 Far Behind As Exports Hit New High

Bernard Murphy — Wed, 17 Aug 2022 09:29:28 +0000

Brazilian medtech exports for the first half of 2022 were 13.8% higher than for the same period in 2021. According to an analysis of government data by ABIMO, the national medical devices industry ass

Survey: Semiconductor Shortage A Change Maker At Medtech Companies

Elizabeth Orr — Fri, 08 Jul 2022 22:11:11 +0000

Device manufacturers have become more pessimistic about the ongoing semiconductor chip shortage as health care providers look to alternative products and treatments, new research from Deloitte Consu

QUOTED. Dennis Gucciardo.

Fri, 27 May 2022 16:56:17 +0000

“If for some reason companies think that their management review records or internal audit records will be subject to inspection, I think that's a concern.” – Dennis Gucciardo, partner, Morgan Lewis

QUOTED. Jeff Shuren.

Fri, 01 Apr 2022 18:14:28 +0000

“We are seeing the pipeline of innovative new devices in the US continues to become more robust, improving patient access to medical devices overall.” – Jeff Shuren , director, Center for Devices an

QUOTED. Ricki Chase.

Tue, 15 Feb 2022 17:03:17 +0000

“Do I think they should’ve taken longer? I really do. But it’s just so hard to know. Nobody knows, and anybody who tells you they know is lying unless they actually saw what went into OMB and what cam

QUOTED. Luis Arguello Jr.

Tue, 04 Jan 2022 18:10:13 +0000

“A percentage of the population, not all but let's say a more educated percentage of the population, is going to continue to wear masks – that is for the pandemic or an endemic COVID.” – Luis Arguell

QUOTED. Owlet Baby Care Inc.

Tue, 30 Nov 2021 16:58:21 +0000

“The letter we received from the agency did not identify any safety concerns about the Smart Sock; rather, the FDA asserts that the Smart Sock should be classified as a medical device in the US becaus

QUOTED. Ben Powers.

Fri, 26 Nov 2021 16:09:16 +0000

“Technology is not keeping up with health care needs, especially in the infusion device space.” – Ben Powers , VP of infusion pumps, Ivenix Click here for a free trial of Medtech Insight