Critical need for electrophysiology devices to treat pediatric heart patients is focus of medical device pitch competition with $150K in awards

Children's National Hospital performs first minimally invasive spinal tether surgery in region

Applications open now for May 12 first round pitch event April 09, 2021 Congenital heart disease (CHD) affects six out of 1,000 babies born in the U.S. each year and is often complicated

Read More Critical need for electrophysiology devices to treat pediatric heart patients is focus of medical device pitch competition with $150K in awards

Oxford Endovascular raises $10M to develop ‘origami’ medical device

OxiFlow

Origami is more traditionally associated with the art of paper folding, but one British startup is using the technique to develop a treatment for brain aneurysms. Oxford Endovascular Ltd has raised $10 million in Series A funding for its OxiFlow

Read More Oxford Endovascular raises $10M to develop ‘origami’ medical device

French medical device manufacturer UroMems completes €23M in Series B funding

electronic artificial urinary sphincter

Grenoble-based developer and manufacturer of the electronic artificial urinary sphincter (eAUS), UroMems has raised an additional €7 million in the second round of its Series B financing which was completed in May 2020. The additional investment was provided by existing

Read More French medical device manufacturer UroMems completes €23M in Series B funding

Helius Medical’s device gets FDA all clear to stimulate the brain via the tongue

PoNS, Helius Medical Technologies

What’s the best way to stimulate the brain? For Helius Medical Technologies, it’s through the tongue. Electrical stimulation of the brain to treat muscles that are weakened or dysfunctional can work, but the approach presents some challenges. Deep brain stimulation

Read More Helius Medical’s device gets FDA all clear to stimulate the brain via the tongue

Merck sets up Organon spinout with a women’s health medical device acquisition

Merck sets up Organon spinout with a women’s health medical device acquisition

  When Merck announced it would spin out its women’s health and off-patent drugs into a new standalone business, the pharmaceutical giant said the new company would also have the capacity to add new products. Merck is giving its spinout

Read More Merck sets up Organon spinout with a women’s health medical device acquisition

Healthcare must move toward a circular economy, and single-use device reprocessing offers a template to follow

circular economy

2021 will be the year when a circular healthcare economy will become a vital conversation in the United States. The pandemic has led to a focus on the need to re-use some medical devices and underscored the need for hospitals

Read More Healthcare must move toward a circular economy, and single-use device reprocessing offers a template to follow

FDA grants EUA to COVID-19 screening device using machine learning

FDA grants emergency approval for first fully at-home COVID-19 test without prescription

Dive Brief: FDA has granted emergency use authorization to a machine learning system designed to spot signs of COVID-19 infection in otherwise asymptomatic individuals. The product, which is not classed as a diagnostic device, consists of an armband that uses

Read More FDA grants EUA to COVID-19 screening device using machine learning

CMS puts the brakes on breakthrough device coverage rule

CMS puts the brakes on breakthrough device coverage rule

Dive Brief: CMS has postponed for 60 days the implementation of a final rule that would provide immediate Medicare reimbursement for devices authorized through FDA’s breakthrough device program, saying it could revise, further delay or even rescind the proposed action

Read More CMS puts the brakes on breakthrough device coverage rule

GE Healthcare announces its first wireless portable ultrasound device

The Vscan Air with its smartphone app

GE Healthcare has pulled back the curtain on the Vscan Air, a wireless take on the handheld ultrasound technology it first debuted more than a decade ago. Cleared by the FDA back in November, the battery-powered device is intended for

Read More GE Healthcare announces its first wireless portable ultrasound device

FDA approval brings remote programming for Abbott’s deep brain stimulation device

UPMC Enterprises' latest spinout uses natural language processing to enhance care quality

The digitization of implanted devices continues apace. On Monday, Abbott announced the launch of its FDA-approved NeuroSphere Virtual Clinic by which patients implanted with the company’s deep brain stimulation devices for Parkinson’s Disease, essential tremor and chronic pain can have

Read More FDA approval brings remote programming for Abbott’s deep brain stimulation device