MassDevice Archives - Page 410 of 587 - Medical Design Sourcing

Can virtual training ever really compete with live training?

By Frank Sculli, CEO at BioDigital

Will telehealth visits plummet once the pandemic is fully behind us? Will industry conferences be as well attended as they were before COVID-19 changed the game? Will HCP face-to-face engagement be what it once was?

While there is still a lot of uncertainty about how our post-pandemic return to normalcy will look, we can count on one thing: virtual training is here to stay. Virtual learning has often been viewed as less effective than live training, but when done right, studies show it can be even more valuable. Here are four ways to build a virtual training program that matches the traditional live classroom experience:

Replicate real life. This might sound obvious but think about it for a moment. When medical device sales trainees complete their training, what awaits them? People in a 3D world requiring interaction and engagement— not static images and Powerpoint based lectures. Effective training means …

NeuroPace wins five-year $9.3M grant from NIH

NeuroPace today announced that it has received a $9.3 million National Institutes of Health grant to study Lennox-Gastaut Syndrome treatment.

The NIH through the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative will provide up to $9.3 million over a five-year period to evaluate the use of Mountain View, Calif.-based NeuroPace’s RNS neuromodulation system to treat Lennox-Gastaut Syndrome (LGS).

“LGS is a horrific epilepsy syndrome that develops in very young children and results in daily seizures, frequent seizure emergencies and hospitalizations, and significant developmental delays,” Tracy Dixon-Salazar, executive director of the LGS Foundation, said in a news release. “Most people living with LGS have tried more than a dozen treatments and yet seizures persist and families live life waiting for the next seizure crisis. I am so encouraged by the research being done with the RNS System and am hopeful that …

Walmart teams up with Novo Nordisk to launch private-brand analog insulin

Walmart (NYSE:WMT) is launching what it describes as the first private label analog insulin. The company estimates the insulin products will save customers between 58% and 70% of the cost of branded insulin.

Novo Nordisk (NYSE:NVO) will manufacture the analog insulin, which is a type of lab-grown insulin genetically engineered to optimize glucose control. The retail price of analog insulin vials will be $72.88, while a FlexPen insulin pen will cost $85.88. Walmart has concluded that the per-unit savings of the products will be $101 per vial and $251 per insulin pen, respectively.

The insulin will only be available through Walmart’s ReliOn brand of diabetes products.

Get the full story from our sister site, Drug Delivery Business.

Neuroelectrics wins FDA breakthrough device designation for its epilepsy-treating neuromod

Brain stimulation tech developer Neuroelectrics announced today that it’s secured FDA breakthrough device designation for its Starstim neuromodulation platform to treat refractory focal epilepsy.

Starstim includes transcranial electrical stimulation (tES), personalized treatment protocols and a secure cloud-based mechanism to deliver treatment anywhere.

“We are excited to receive the FDA Breakthrough Device Designation for our lead program in refractory focal epilepsy. We hope that it will speed the evaluation of a new therapeutic modality that could potentially help patients who currently have no effective treatments available,” said Neuroelectrics co-founder and CEO Ana Maiques said in a news release.

The Cambridge, Mass./Barcelona, Spain–based company recently completed a pilot study of its Starstim tES system in 20 adult and pediatric patients with medically refractory focal epilepsy. The study found a 44% median reduction in seizure frequency…

Philips seeks to reduce MRI evaluation of the heart down to a few minutes

[Image from Philips]Royal Philips (NYSE:PHG) announced today that it’s part of a research project for developing a change in MRI imaging in cardiology.

Amsterdam-based Philips is collaborating with the Spanish National Center for Cardiovascular Research (CNIC) to research a new technique to bring ultra-fast, easy cardiac magnetic resonance (MR) imaging to clinical settings in a way that benefits more patients.

Get the full story at our sister site, Medical Design & Outsourcing.

PharmaJet begins enrollment for needle-free COVID-19 vaccine trial

PharmaJet announced today that it began enrollment for a Phase 1 clinical trial for its needle-free COVID-19 vaccine in Australia.

Golden, Colo.-based PharmaJet’s needle-free injection systems will be studied with Covigen, a DNA-based vaccine developed by French-Thai pharmaceutical company BioNet-Asia in collaboration with Melbourne, Australia-based Technovalia.

Get the full story at our sister site, Drug Delivery Business News.

Abbott wins new FDA approvals for stent family including nod for next-gen Xience Skypoint

Abbott (NYSE:ABT) announced today that the Xience stent family received FDA approval for one-month dual antiplatelet therapy (DAPT) labeling.

The FDA’s approval for one-month (as short as 28 days) DAPT labeling applies to high bleeding risk (HBR) patients in the U.S., according to a news release. The company also recently received CE mark approval in Europe for DAPT as short as 28 days, which it says gives Xience stents the shortest DAPT indication in the world.

In addition to the new indication for HBR patients, Abbott said it won FDA approval and CE mark for the next-generation Xience Skypoint stent, which it says is easier to place and allows physicians to treat larger blood vessels through improved stent expansion that can open clogged vessels more effectively.

Xience Skypoint won approval for use in HBR patients with one-month DAPT labeling, with Abbott touting data from 120 clinical trials of 125,000 patients as proof of safety, effectiveness…

Medtronic announces executive leadership changes

Medtronic (NYSE:MDT) today confirmed two personnel moves within its executive leadership team, with one retirement and a new appointment.

Senior vice president, general counsel and corporate secretary Bradley E. Lerman will retire, having notified the board of directors on June 24 that he planned to step down effective Dec. 31, 2021, according to an SEC filing.

Lerman served on Medtronic’s executive committee for more than seven years and spent more than 40 years in the law field, both in the public sector and private practice. Medtronic said it initiated an internal and external candidate search to identify Lerman’s successor and ensure a smooth transition.

The Fridley, Minn.-based medtech giant also announced the appointment of Jennifer Kirk as its principal accounting officer, global controller and chief accounting officer.

Medtronic’s previous controller recently retired, as did its chief accounting officer, which led the com…

Nuvasive’s Pulse robot-assisted spinal surgery platform wins CE mark

NuVasive (NSDQ:NUVA) announced today that it received CE mark approval for its Pulse spinal surgical automation platform.

San Diego-based NuVasive touts its Pulse system as a first-of-its-kind technology designed to integrate radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring and spinal alignment tools into one platform.

According to a news release, Pulse is currently the only enabling technology platform capable of utilization in 100% of spine procedures and throughout the entire operating room workflow. The company said it increases safety, efficiency and procedural reproducibility while addressing several common clinical challenges in spine surgery.

With CE mark approval, NuVasive said clinical evaluations for Pulse are now underway across multiple countries throughout Europe. Pulse has held FDA approval in the U.S. since July 2018.

“The latest CE mark approval and clinical evaluations are ke…

Viz.ai wins CE mark for AI-powered stroke care software

Viz.ai announced today that it received CE mark approval for its flagship Viz LVO AI-based stroke care software platform.

San Francisco-based Viz.ai developed Viz LVO to use AI to automatically detect suspected large vessel occlusion (LVO) strokes on computed tomography angiography (CTA) imaging. Once the platform detects stroke, it directly alerts on-call stroke specialists about potentially treatable patients in a standalone or multi-hospital network, according to a news release.

The company touts its platform as capable of synchronizing stroke care, decreasing time to treatment and providing overall improvement to patient outcomes.

A recent, real-world, multi-center study using the platform found that median time-to-notification clocked at five minutes and 45 seconds across all sites using Viz LVO. The platform achieved 96% sensitivity and 94% specificity in identifying LVOs in 2,544 consecutive patients from 139 hospitals.

“Minutes matter when…

United Therapeutics touts study results for inhaled Tyvaso treatment

Image from United Therapeutics

United Therapeutics (NSDQ:UTHR) today announced positive results from an analysis of forced vital capacity (FVC) change with its Tyvaso treatment.

Research Triangle Park, N.C.-based United Therapeutics developed Tyvaso (treprostinil) as an inhalation solution for patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The FDA approved the treatment in April 2020.

Get the full story at our sister site, Drug Delivery Business News.

Giiant Pharma extends seed round with $1.25M

Giiant Pharma announced today that it added $1.25 million to its seed financing round to ensure reaching clinical proof-of-concept.

Montreal-based Giiant’s $750,000 in funding from AQC Capital, plus $500,000 from CQDM, adds to the seed round closed last month to bring the company’s total funding to nearly $15 million.

Get the full story at our sister site, Drug Delivery Business News.