MassDevice Archives - Page 421 of 587 - Medical Design Sourcing

Abbott, Walgreens partner on boosting COVID-19 testing in Philadelphia

Abbott (NYSE:ABT) and Wallgreens announced a pilot program designed to increase access to rapid COVID-19 testing in Philadelphia.

Under the newly formed partnership, Pennsylvania Electronic Benefit Transfer (EBT) cardholders in Philadelphia will be able to receive Abbott’s BinaxNOW COVID-19 antigen self tests weekly at no cost, according to a news release. Customers can visit any of 16 Walgreens’ 16 locations within Philadelphia’s city limits over the span of the program, which ranges all the way through the July 4 holiday.

Each cardholder can receive two test packs (two-count) per family member per week for up to five household members, totaling 10 packs (20 tests in total) per week for a cardholder, their spouse and their three dependents. Each family member would be able to test themselves twice over three days with at least 36 hours between tests.

Through the pilot program, Abbott and Walgreens aim to increase the understanding of h…

EvoEndo raises $10M for unsedated transnasal endoscope

EvoEndo today said it secured $10.1 million in equity financing to develop its unsedated transnasal endoscopy system.

The Denver-based company’s funding round included family offices and early-stage life science investors.

Get the full story on our sister site, Medical Tubing + Extrusion.

EyeYon Medical corneal endema treatment device wins CE mark

EyeYon Medical announced today that it received CE mark approval for its EndoArt synthetic endothelium replacement implant.

Tel Aviv, Israel-based EyeYon designed EndoArt to replace dysfunctional endothelium in patients awaiting human donor tissue as a first-line treatment for patients with chronic corneal edema, as patients with a nonfunctioning endothelium experience excess fluid flowing into the cornea, which can produce severe vision loss, pain and irreversible scarring of the human tissue.

The implant enables doctors to treat endothelial-related chronic corneal edema with a minimally invasive surgery. According to a news release, the system became the only ophthalmic device in the world to receive both China’s Innovative Device Status and U.S. breakthrough device designation from the FDA.

EndoArt proved its safety and effectiveness in clinical trials across Europe, while other clinical trials are currently underway in India and Israel.

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BD surpasses 2 billion orders for COVID-19 injection devices

[Image from BD]BD (NYSE:BDX) announced today that orders for its needles and syringes hit 2 billion amid global COVID-19 vaccination efforts.

Franklin Lakes, N.J.-based BD’s latest milestone comes less than six months after the company surpassed 1 million orders for vaccine delivery devices in December 2020.

The order total encompasses commitments to governments all over the globe, including the U.S., Australia, Brazil, Canada, France, Germany, India, the Philippines, Saudi Arabia, South Africa, Spain and the UK, among others.

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

CVRx is going the IPO route

CVRx plans to hold an IPO to raise up to $75 million as it seeks to further commercialize its neuromodulation device to treat the heart.

That’s according to a June 4 registration statement with the U.S. Securities and Exchange Commission that follows up on a registration confidentially filed with the SEC in April.

The plan is for Brooklyn Park, Minn.–based CVRx to trade on the Nasdaq under the symbol CVRX. Underwriters include J.P. Morgan, Piper Sandler, William Blair and Canaccord Genuity.

CVRx’s FDA-approved Barostim Neo uses patented technology to send electrical pulses to baroreceptors in the wall of the carotid artery. The treatment is meant to restore balance to the automatic nervous system and improve the symptoms of heart failure.

The company brought in about $6 million a year in 2019 and 2020, with sales only slightly down amid the COVID-19 pandemic. Company officials tout an initial $2.9 billion opportunity to treat heart fai…

Abbott wins CE mark for Amplatzer steerable delivery sheath

Abbott (NYSE:ABT) announced today that it received CE mark and Health Canada approval for its Amplatzer steerable delivery sheath.

The company touts the Amplatzer sheath as the first steerable delivery sheath to be developed specifically for minimally invasive left atrial appendage (LAA) occlusion (or closure) procedures for patients diagnosed with atrial fibrillation who are at risk of ischemic stroke, according to a news release.

Abbott Park, Ill.-based Abbott designed the sheath for use with its Amplatzer Amulet LAA occluder. The company said the sheath also features bi-directional steering and an auto-lock setting for more accurate alignment with the LAA.

Additionally, the sheath includes a hemostasis valve designed to stabilize blood flow and minimize blood loss during the procedure. Abbott said the new design reduces the need for catheter manipulation or exchanges, thus reducing issues that slow down procedures or cause further blood loss.

M…

BD is upping its game on cybersecurity

BD (NYSE: BDX) is touting that it is the first medical technology company authorized as a Common Vulnerability and Exposures (CVE) Numbering Authority by the CVE Program.

BD officials say the authorization further boosts the company’s healthcare cybersecurity leadership.

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

FDA approves Medtronic’s SenSight directional lead system for DBS therapy

Medtronic (NYSE:MDT) announced today that it received FDA approval for its SenSight directional lead system used in deep brain stimulation therapy.

Fridley, Minn.-based Medtronic designed the SenSight directional lead system for DBS therapy to combine directionality and sensing to allow physicians to deliver precise, patient-specific DBS therapy for treating some symptoms associated with movement disorders including Parkinson’s disease, dystonia and essential tremor and medically refractory epilepsy, according to a news release.

The company touts SenSight as the first directional, sensing-enabled lead designed to improve the detection of local field potentials (LFPs). It can be paired with the Percept PC device to expand on Medtronic’s BrianSense technology to allow for the capturing and recording of enhanced directional LFP information from the implanted lead.

Multi-disciplinary teams at the University of Florida performed the first implants…

Zimmer Biomet expands executive leadership team

Zimmer Biomet (NYSE:ZBH) today said it has appointed Wilfred van Zuilen as president of Europe, Middle East, Africa, and Nitin Goyal as chief science, technology, and innovation officer.

“It is an exciting time at Zimmer Biomet as we continue to build out our Executive Team to ensure we have the proven, strategic leadership in place to guide us through the third phase of our business transformation,” president and CEO Bryan Hanson said in a news release. “As an organization, we remain focused on developing our people, placing the right team members in the right roles and providing the tools and support needed to execute and drive our performance.”

Van Zuilen will be responsible for the marketing, sales and distribution of products and services in the EMEA region.

Prior to joining the company, van Zulien was the regional VP to Northwestern Europe at Medtronic. He has also held numerous leadership roles at Medtronic, Covidien, Novar…

MedTech 100 roundup: Rebound hits a snag

Two weeks ago, medtech was on the rise following a rough stretch, but the past week brought the industry slightly back down to earth.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 4) at 106.96 points, producing a -1.4% dip from the 108.5-point mark set one week prior (May 28). It halts the progress made over a couple of weeks in which the industry produced an uptick, following its 1.4% rise from May 14 to May 21.

Having endured its largest slide of 2021 in recent weeks, the index is still in a better position to produce another upswing after demonstrating signs of picking up again when April brought the industry’s all-time best performance.

Even with setbacks that slowed the industry this past week, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 15.9% rise from the pre…

Tandem Diabetes Care touts study results for insulin pump with closed-loop technology

Image from Tandem Diabetes

Tandem Diabetes Care (NSDQ:TNDM) today shared real-world data on its t:slim X2 insulin pump with Control-IQ advanced hybrid closed-loop technology.

Presenting at the 14th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD), the company touted immediate and sustained improvements in time-in-range (TIR) observed in more than 9,000 people with diabetes using the system for 12 months.

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

The medical device startup that is disrupting Big Pharma

Fisher Wallace has raised millions via equity crowdfunding to redefine mental health treatment.

The CEO of Fisher Wallace Laboratories, a medical device startup that is disrupting the mental health industry with its FDA-Cleared wearable brain stimulation technology, envisions a near-future when drug therapy is the last resort for treating depression, anxiety, and insomnia. The company has raised millions on the equity crowdfunding platform StartEngine to compete with Big Pharma by selling an FDA-Cleared device that’s affordable out-of-pocket, causes almost no side effects, and has been shown to be effective in recent clinical trials.

“The most commonly prescribed antidepressants were developed in the 1980s, cause side effects more often than they produce symptom remission, cost a fortune when you include doctor visits, and need to pass through the digestive system before reaching the brain,” explains Kelly Roman, CEO of Fisher Wallace.

Fisher Wal…