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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 Research & Development
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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

QUOTED. 22 August 2019. Omar Ishrak.

While Medtronic PLC's Brain Therapies business was by far the fastest-growing unit in the first quarter of fiscal 2020, sales of spine surgery products grew faster in the first quarter than they have in nine quarters. See what Medtronic's CEO Omar Ishrak said about it here.

Quoted Sales & Earnings

Brain Therapies Leads Medtronic’s Growth In First Quarter Of Fiscal 2020

The medtech giant reported revenue of $7.5bn in the quarter that ended on 26 July, up 3.5% year-over-year basis, led by 12.5% growth in revenues from emerging markets. Medtronic’s fastest-growing business is its brain therapies unit, which reported 11.4% growth in the quarter.

Sales & Earnings Innovation

Medtronic, Capital District Physicians’ Health Plan Partner To 'Gamify' Diabetes Control

Health plan members will be invited to join Medtronic’s Inner Circle patient engagement program, which applies game design to help motivate and encourage patients with diabetes to achieve monthly health-outcome goals.

Commercial Healthcare Systems

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

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

QUOTED. 15 August 2019. Amy Abernethy.

Here's what Amy Abernethy, the second-highest ranking official at the US FDA, thinks about the use of wearable devices to collect accurate patient data for clinical trials and remote monitoring.

Quoted Digital Health

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

Exec Chat: Deepak Nath, President Of Siemens Healthineers' Laboratory Diagnostics, Offers An Insider's Look At AACC 2019

At this year's AACC annual conference, Medtech Insight sat down with Siemens Healthineers' president of laboratory diagnostics, Deepak Nath, to learn about plans for their flagship Atellica platform including the new Asa tablet, introduced at this year's show. 

Exec Chat Commercial
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