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Axonics loses IP challenge to Medtronic patents

Medtronic (NYSE:MDT) announced that it picked up three victories in an intellectual property (IP) dispute against Axonics (NSDQ:AXNX) over sacral neuromodulation devices.

According to a news release, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to Medtronic’s InterStim neuromodulation device family. Nearly one year ago, the PTAB handed down a decision to reject one of Axonics’ claims to invalidate a Medtronic patent and has now added three more.

Axonics develops the r-SNM sacral neuromodulation system, which it touts as the first of its kind approved for sale in the U.S., Europe, Canada and Australia and the only SNM device approved for full-body MRI scans without needing the device explanted.

The company, a direct competitor of Medtronic in the space, has rivaled the medtech giant with multiple regulator…

Testing and certification of refurbished medical equipment

By L. Matthew Snyder, Sr. Director of Certification at Intertek

Medical electrical equipment such as MRIs, anesthesia machines, surgical equipment, scanning systems, patient monitors and other types of products are a significant investment for any healthcare organization. Refurbished medical equipment, devices that are reconditioned and made comparable to new products, are becoming a realistic option for the industry given their lower costs. In fact, many original equipment manufacturers are increasingly focused on refurbishing equipment, which in turn is pushing growth of the market.

A potentially more budget-friendly approach, refurbished equipment is an appealing prospect for not only healthcare industries but for others that regularly use electrical devices. Given the increased interest in this type of product, the National Electric Code (NEC) has been updated to better ensure the safety and performance of refurbished (or reconditioned) products. Pr…

FDA clears NeuroOne’s Evo sEEG electrode

NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology.

Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance for temporary (less than 24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain, according to a news release.

The Evo sEEG electrode represents the second FDA-cleared product from NeuroOne its Evo cortical electrode technology in November 2019. The company develops surgical care options for patients suffering from neurological disorders.

NeuroOne’s sEEG electrodes, contrary to cortical electrodes, provide a similar function at the subsurface level of the brain while using a much less invasive process as it does not require the removal of the top portion of the patient’s skull.

The company anticipates a la…

Cardinal Health docks executive bonuses over opioid costs

Cardinal Health CEO Mike Kaufmann (Photo courtesy of Cardinal Health)

Cardinal Health’s board of directors reduced bonus payouts for CEO Mike Kaufmann and his four top-paid executives due to the cost of opioid litigation.

After pressure from investors, Cardinal Health (NYSE:CAH) for the first time has disclosed how its board of directors factored the opioid litigation settlement costs into the pay packages of Kaufmann, Chief Financial Officer Jason Hollar, Pharmaceutical Segment CEO Victor Crawford, Medical Segment CEO Stephen Mason and Chief Legal and Compliance Officer Jessica Mayer.

Get the full story at our sister site, Pharmaceutical Processing World.

Lyra Therapeutics appoints new CFO

LYR-210 is an investigational product designed to provide six months of anti-inflammatory treatment from a single in-office administration(Image from Lyra Therapeutics)

Lyra Therapeutics (NSDQ:LYRA) announced today that it appointed Jason Cavalier as its new chief financial officer, effective today.

Cavalier succeeds the company’s current CFO, Don Elsey, who is retiring while he remains expected to serve in an advisory role to assist with the transition.

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

iRhythm picks former Dexcom COO Quentin Blackford as new CEO

iRhythm Technologies (NSDQ:IRTC) announced today that it appointed Quentin Blackford as its new president & CEO.

Blackford will assume the role of president & CEO and become a member of the company’s board of directors effective Oct. 4, 2021. The company had been searching for a CEO since June when Mike Coyle announced that he would step down for personal reasons. CFO Douglas Devine has served as interim CEO since Coyle’s departure and will continue to do so until Blackford’s position is made effective next month.

Blackford joins as a veteran of more than 20 years in the medical device and digital health space, most recently serving as COO at Dexcom, having initially joined the diabetes technology developer as CFO in 2017.

Before Dexcom, Blackford served as NuVasive’s EVP, CFO, and head of strategy and corporate integrity. Before that, he held multiple roles at Zimmer Holdings. Blackford is currently an independent member …

Xenter taps former Medtronic exec to head medical technologies unit

Xenter today announced that it has appointed Mark Turco as president of its Xenter Medical Technologies business unit.

Turco most recently served as executive VP of research & development and global chief medical officer at Sirtex Medical. He has also served as chief medical officer of Covidien and later the VP and chief medical officer of Medtronic’s aortic, peripheral and vascular divisions. Turco has also held leadership roles at the University of Pennsylvania’s Penn Center for Innovation and had a clinical practice at Washington Adventist Hospital.

“I am very excited to join Xenter in this pivotal leadership role,” Turco said in a news release. “I look forward to aiding in the development of medical technologies using Xenter’s three pillars: medical devices, health data, and therapeutic drugs. I am joining a globally recognized and experienced team that has been tasked with transforming the collection of procedural and patient data usi…

Zoll Medical to acquire Itamar Medical in $538M deal

Zoll Medical announced today that it will acquire Itamar Medical (NSDQ:ITMR) for a total value of approximately $538 million.

Chelmsford, Massachusetts-based Zoll will acquire all outstanding shares of Itamar, a developer of non-invasive devices and solutions for the diagnosis of respiratory sleep disorders, at $31 per American Deposiory Share (ADS), a premium of 50.2% over the price of Itamar’s ADS on the Nasdaq market on Sept. 10.

According to a news release, both companies’ boards approved the deal, which remains subject to approval by shareholders of Itamar, regulatory approvals and other customary closing conditions. The companies expect the transaction to close by the end of 2021 and, once completed, they expect that Itamar’s principal operations will continue at its current location in Caesarea, Israel.

Itamar develops the FDA-cleared WatchPAT home sleep apnea device designed for sleep apnea diagnosis for patients and healthcare…

Medtronic builds suspense for renal denervation study results

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]Medtronic’s clinical study of its Symplicity Spyral renal denervation system for hypertension is likely to go down to the wire for inclusion as a late-breaking clinical trial at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference.

The highly anticipated results will offer new insight into the Fridley, Minnesota-based medical device manufacturer’s quest to build a billion-dollar business treating hypertension. CEO Geoff Martha recently reported “good progress” in those efforts, saying the trial “represents the final piece of a large body of evidence that we intend to submit to the FDA for approval.”

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

FDA outlines plan to ‘follow the science’ as it mulls over COVID-19 vaccines for children

[Photo by Eugene Chystiakov]FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children.

In a news release attributed to acting commissioner Dr. Janet Woodcock and director of the FDA’s Center for Biologics Research and Evaluation Dr. Peter Marks, the FDA said it plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country.

Get the full story at our sister site, Drug Discovery & Development.

Nectero Medical completes $19.5M Series C funding round led by Boston Scientific

Nectero Medical announced today that it closed a $19.5 million Series C funding round led by new investor Boston Scientific (NYSE:BSX).

Tempe, Arizona-based Nectero Medical said in a news release that proceeds will be put toward its in vivo and clinical trials for the development of a treatment platform designed to stabilize small- to mid-sized aortic aneurysms by significantly reducing their growth rate.

Nectero said its endovascular aortic stabilization treatment (EAST) has demonstrated impressive early clinical results that suggest the potential ability to dramatically inhibit AAA disease growth. The company designed it to prevent rupture and inhibit further degradation of the aortic tissue with a one-time, catheter-based procedure that locally delivers a proprietary compound.

The company currently has the EAST system under evaluation in treating AAA patients in a multi-site, Phase 1 safety study to see if the system can prevent aneurysmal rupture thr…

Lyra touts non-human trial of XTreo drug-eluting implant

LYR-210 is an investigational product designed to provide six months of anti-inflammatory treatment from a single in-office administration(Image from Lyra Therapeutics)

Lyra Therapeutics (NSDQ:LYRA) is touting preclinical data for its XTreo drug-eluting implant for dosing in local sinus tissues.

Watertown, Massachusetts-based Lyra’s preclinical results were published — “Drug Release and Pharmacokinetic Evaluation of Novel Implantable Mometasone Furoate Matrices in Rabbit Maxillary Sinuses” — were published online in the peer-review journal, American Journal of Rhinology & Allergy.

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