MassDevice Archives - Page 323 of 587 - Medical Design Sourcing

Align Technology settles patent infringement, antitrust suits with 3Shape

Align Technology (Nasdaq: ALGN) has settled its five-year legal battle with Denmark-based dental scanner and software maker 3Shape.

The settlement, announced yesterday, covers 3Shape’s patent infringement claims pending in federal courts in Delaware and eastern Texas. 3Shape also had an antitrust claim pending against Align in Delaware District Court, and both companies had petitions to invalidate patents before the United States Patent Trial and Appeal Board.

3Shape, among other things, claimed that Align’s ITero scanners infringed on its intellectual property.

The settlement’s financial terms are confidential; Align officials do not expect the settlement to affect its ongoing operations and financial results.

The settlement also allows Invisalign customers in certain countries and territories outside the United States, China and Japan to use scans from 3Shape Trios 2 and Trios 3 scanners for Invisalign case submissions.

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CereVasc wins FDA IDE approval to begin eShunt pilot study

CereVasc today announced that it received an FDA investigational device exemption approval to begin a trial of the eShunt for normal pressure hydrocephalus.

The Boston-based company can initiate its pilot trial of the eShunt system in patients with normal pressure hydrocephalus (NPH). The eShunt device offers a minimally invasive treatment with the potential to result in benefits over the current gold-standard treatment.

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

Second Sight Medical, Nano Precision Medical merging to create therapeutic implant company

Second Sight Medical Products (NSDQ:EYES) and Nano Precision Medical agreed to a merger deal that will result in a focus on drug-device medical implants.

The two companies entered into a definitive agreement under which privately held Nano Precision Medical (NPM) will merge with a wholly-owned subsidiary of Second Sight in an all-stock transaction, with NPM to be the surviving company under Second Sight’s ownership.

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

Haemonetics posts mixed-bag Q3, tightens guidance range

Haemonetics (NYSE:HAE) shares dipped slightly before hours on third-quarter results that were mixed compared to the consensus forecast.

The Boston-based company posted profits of $23.2 million, or 45¢ per share, on sales of $259.8 million for the three months ended Jan. 1, 2022, for a 27.1% bottom-line slide on sales growth of 8.1%.

Adjusted to exclude one-time items, earnings per share were 84¢, 11¢ ahead of Wall Street, where analysts were looking for sales of $266.7 million.

“Our third-quarter results reflect our agility and resilience in meeting the challenges of the pandemic on U.S. blood and plasma collections and some hospital products,” Haemonetics CEO Chris Simon said in a news release. “Plasma collections improved and we continued to convert customers to our latest NexSys and Persona technologies, while our hospital business delivered double-digit growth and a new record quarter for sales in hemostasis management and vascular closur…

Paralyzed patients walk, swim and cycle with spinal cord neuromodulation implant

The spinal cord stimulating electrodes are implanted directly on the spinal cord, below the vertebrae. [Image courtesy of the Swiss Federal Institute of Technology in Lausanne]The latest iteration of a spinal cord stimulation implant has allowed three paralyzed patients to take steps independently on a treadmill within a day of their device’s activation, and to stand, walk, swim and pedal a bicycle after five months of rehab.

In 2018, the technology helped a patient get out of his wheelchair and walk after being paralyzed by a partial spinal cord injury, but the latest results helped three men with complete spinal cord injuries walk again outside of the lab.

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

CooperCompanies buys Cook Medical’s reproductive health business for $875M

Cook Medical announced today that it has signed a letter of intent to sell its Reproductive Health business to CooperCompanies.

CooperCompanies (NYSE:COO) plans to pay privately-held Cook Medical $875 million — $675 million at closing, with the remaining $200 million paid in four $50 million annual installments.

The proposed deal is subject to applicable local consultation obligations and regulatory approvals.

For more than 40 years, Cook focused on Reproductive Health. Over the decades, it developed products for obstetrics and gynecology, in vitro fertilization (IVF) and assisted reproductive technology (ART).  The company’s work included developing the first needle specifically for IVF treatments.

“Our history with reproductive health has been full of innovations to help patients fulfill their dreams of having a family,” D.J. Sirota, SVP of Cook Medical’s MedSurg specialty, said in a news release.

“This agreement represents more tha…

Medtronic issues voluntary recall for TurboHawk 6Fr Plus directional atherectomy system

Medtronic (NYSE:MDT) today announced that it issued a voluntary recall for its TurboHawk 6 French (6Fr) Plus directional atherectomy system.

The recall for the TurboHawk Plus system relates to the risk associated with tip damage caused by guidewire prolapse. A recall for the HawkOne directional atherectomy system that related to a similar issue was deemed Class I by the FDA last month.

Fridley, Minnesota-based Medtronic said in a news alert that approximately 800 TurboHawk Plus devices are impacted by the recall. There have been zero reports of tip damage and zero reports of injury or death on the device, as the company made the recall based on design similarities between the TurboHawk Plus and HawkOne systems, so the same warnings and precautions apply.

There is no product retrieval or disposal requested at present and there are no actions required for patients treated with the TurboHawk Plus 6Fr or any of Medtronic’s directional atherectomy devices.

Imagining the future of cloud-connected medical devices with Johnson & Johnson leaders

Johnson & Johnson Office of Digital Innovation Leader Peter Schulam [Photo courtesy of Johnson & Johnson]Cloud-connected medical devices already collect and analyze data, talk to each other and use artificial intelligence to improve patient care, but how much more might be possible in the not-so-distant future? Surgery simulations? Smart ambulances? Full-body scanners? One-click healthcare?

I’ve been exploring that question for an upcoming edition of Medical Design & Outsourcing magazine — and asked two leaders in the Johnson & Johnson (NYSE:JNJ) medical device business to put their imagination to work as they embark on a cloud partnership with Microsoft (NASDAQ:MSFT). This second part of the conversation (read the first part here) also discusses the regulatory aspect of cloud-connected medical devices and how the medtech industry can keep advancing the technology.

Johnson & Johnson Group CIO and Global Vice President of Medical Devices Larry Jone…

Vyaire Medical voluntarily recalls some Bellavista ventilators

Vyaire Medical recently announced that its subsidiary ImtMedical has initiated a voluntary field correction for certain BellaVista ventilators.

The company reported a potential issue with BellaVista 1000 and 1000e ventilators that have specific software and configuration combinations that can cease ventilation and generate a technical failure alarm. The issue affects ventilators distributed between Mar. 21, 2019 and Dec. 23, 2021, that have software version 6.0.1600.0 or higher installed, which was deployed in February 2021, and also have the data communication port set to “HL7.”

Vyaire Medical told customers with software version 6.0.1600.0 or higher installed to immediately disable the HL7 data communication if activated. The devices are at risk of unintentional ceasing of ventilation if the data communication is not disabled.

The recall was issued based on reports that some of the ventilators unintentionally ceased ventilation during clini…

FDA resumes inspections in U.S. as omicron cases decline

The FDA announced last week that it is set to resume conducting domestic surveillance inspections after a brief postponement.

In December, the agency confirmed temporary changes to inspectional activities due to COVID-19 as the omicron variant of the virus led to surges across the world. The FDA implemented the changes in the U.S. on Dec. 29, 2021, to ensure the safety of its employees and the firms it regulates, highlighting plans to continue mission-critical work while postponing certain inspectional activities.

According to a news release, the FDA determined on Feb. 2 that it would resume the domestic surveillance inspections across all commodities following a decline in COVID-19 cases. The resumption went into effect today, Feb. 7.

The FDA said that, in addition to resuming the surveillance inspections, it continues to conduct both foreign and domestic mission-critical inspections and provide oversight of foods, drugs, medical products and tobacco in…

Zimmer Biomet’s upcoming spinoff ZimVie expecting flat revenue in 2022

ZimVie — the upcoming spinoff of Zimmer Biomet’s spine and dental business — is forecasting that annual revenue will stay flat at $1 billion in 2022.

The news was part of ZimVie management’s announcement of an Investor Day today. They said plans for the spinoff remain on track, with ZimVie shares commencing trading on March 1.

ZimVie previously said it has filed to have its shares traded on the Nasdaq under the symbol ZIMV. The new 2,700-employee company will have its headquarters in Westminster, Colorado.

Today’s forecast also included adjusted EPS of $2.10 to $2.30 for the fiscal year ended Dec. 31, 2022.

“At ZimVie, we intend to prioritize innovation and enhanced commercial and operational focus to improve the adoption of our product platforms within the growing $20 billion global dental and spine markets,” ZimVie CEO Vafa Jamali said in a news release.

“As an independent company, we will be uniquely p…

Abbott confirms implants of dual-chamber leadless pacemaker in trial

Abbott (NYSE:ABT) announced today that it completed the first implants of its dual-chamber leadless pacemaker in a clinical trial.

The company’s prospective, multicenter, international, single-arm, pivotal investigational Aveir DR i2i study will evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in patients indicated for a DDD(R) or dual-chamber bradycardia pacing pacemaker.

Abbott expects the Aveir DR i2i study to enroll up to 550 patients at up to 80 sites in the U.S., Canada, Europe and Asia-Pacific. All patients will be followed for a minimum of 12 months post-implant. The Aveir DR leadless pacemaker is currently an investigational device.

The Abbott Park, Illinois-based company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium. The company’s aim is to regulate the heart rate synchronously…