AFib Archives - Page 2 of 2 - Medical Design Sourcing

ITC rules in favor of AliveCor in patent spat with Apple

A figure from AliveCor’s patent, included in the PTAB ruling

AliveCor announced today that the International Trade Commission (ITC) ruled that the Apple Watch infringed its patented technology.

Along with the final determination, the ITC issued a limited exclusion disorder (LEO) and a cease and desist order. It set a bond in the amount of $2 per unit of infringing Apple Watches imported or sold during its review period.

In a news release, AliveCor said it could potentially impact sales of “millions of infringing Apple Watches.”

“Today’s ITC ruling is a win for innovation and consumer choice,” said Priya Abani, CEO of AliveCor. “The ruling underscores the importance of upholding intellectual property rights for companies like AliveCor and scores of others whose innovations are at risk of being suppressed by a Goliath like Apple. We look forward to continuing to build and innovate on our cardiac solutions to improve people’s l…

Apple scores a win in IP spat with AliveCor

A figure from AliveCor’s patent from in the PTAB ruling

The U.S. Patent Trial and Appeal Board has dealt AliveCor a setback in its intellectual property fight with Apple over the technology behind wearable AFib detection.

In a ruling entered yesterday, the PTAB agreed with Apple that AliveCor’s claims around U.S. Patent No. 10,595,731 B2 were unpatentable. The board made the determination based on the IP law concept of obviousness. Basically, someone with ordinary skills in the field would have found the patent obvious. They could have created what AliveCor was patenting based on the research and technological advancements that had already taken place.

The PTAB said: “Considering all the art and argument of record, and the level of ordinary skill in the art, we agree with [Apple] that ‘after an ECG is measured, it would have been obvious to confirm arrhythmia detection using a machine learning algorithm based on the PPG data, motion sens…

Google, Fitbit unveil smartwatch that can detect AFib

[Image from Google/Fitbit]Google today unveiled its first full-featured premium smartwatch developed with Fitbit’s health and fitness expertise.

In August, Google unveiled its new Fall lineup that included The Fitbit Sense 2. Google said at the time that it marks the company’s “most advanced health-focused smartwatch.” It features more than six days of battery life. The watch aims to help users manage stress and track heart health through sensors that can detect signs of AFib, among other things.

Google’s latest announcement features the Google Pixel Watch as part of the fall product line. The company called it a “natural extension” of the Pixel family in a blog post. It said the watch combines “smarts and helpfulness” with Fitbit’s health and fitness expertise.

Features include water resistance and scratch resistance with a design meant for wearing all day and night.

The watc…

HeartBeam enables smartwatch connectivity for heart monitoring

HeartBeam (Nasdaq:BEAT) announced today that it expanded its product portfolio to add arrhythmia detection capabilities to wearables.

Santa Clara, California-based HeartBeam said in a news release that it aims to serve the growing cardiac device wearable market. The pipeline advancement allows for the addition of arrhythmia detection capabilities for AFib and other arrhythmia monitoring.

The company’s broader product portfolio builds on recently issued patents, HeartBeam said. Its 12-lead electrocardiogram (ECG) patch picked up a patent last month.

HeartBeam introduced a three-lead 3D vector ECG (VECG) credit card-sized HeartBeam AIMIGo 3L device. The device records cardiac activity and displays signals for clinician review. It provides the regulatory foundation for subsequent products in the company’s portfolio. HeartBeam plans to submit to the FDA for 510(k) clearance in the fourth quarter of this year.

Additionally, the company leve…

iRhythm stock up on positive news out of CMS

iRhythm Technologies (Nasdaq:IRTC) stock soared today on positive reimbursement news out of CMS as the agency makes 2023 fee schedule proposals.

Truist analysts yesterday evening pointed to CMS proposing a national coverage determination (NCD) of $229 for the ZioXT wearable cardiac monitor. When incorporating the geographic physician payment adjustments, the analysts thought the actual payment over time to reach over $280.

“We think investors in recent weeks were even potentially bracing for a rate lower than [around] $230, and thus this rate level should serve as a clearing event,” said Truist analysts David Rescott, Richard Newitter and Samuel Brodovsky.

A final CMS rule for fiscal year 2023 is expected around November, according to the analysts.

IRTC shares up more than 22% to $140.99 apiece in midday trading today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — …

CoreMap raises $23 million to fund AFib mapping development

Sarah Kalil is CEO and co-founder of CoreMap. [Photo courtesy of CoreMap]CoreMap today announced it closed a $20 million Series B financing to accelerate the development of its cardiac arrhythmia diagnostic technology and launch pilot studies.

The Burlington, Vermont–based company said it also closed on a $3 million Series A Milestone financing that was part of its $10.5 million Series A in September 2020. In addition, CoreMap won a National Science Foundation research grant that same month after participating as one of the startups in MassMEDIC’s IGNITE virtual accelerator when the program relaunched in 2019.

CoreMap said pre-clinical and clinical studies have successfully demonstrated the CoreMap System, which consists of the company’s high-resolution Invenio catheter and VidereX workstation.

“We have a catheter that will go inside the heart to record the electrical activity with high spatial resolution and create unambiguous electrograms. And that’s not …

iRhythm plans silent AFib screening pilots, high-level hires and Zio Watch evaluations

iRhythm’s Zio XT cardiac monitor [Image from iRhythm]

iRhythm Technologies (NSDQ:IRTC) has big plans for 2022 and its remote external electrocardiogram monitors as the medical device developer gears up for growth.

President and CEO Quentin Blackford is looking to hire an international general manager among other roles in the coming months, he told Medical Design & Outsourcing after presenting at this month’s 2022 J.P. Morgan Healthcare Conference, where he laid out his vision for profitably scaling the company.

Asked by MDO whether Blackford is planning a reorganization or restructuring after he discussed the cost-consciousness side of his growth plans, an external spokesperson offered more details from the CEO.

“At a leadership level, we are actively structuring our C-suite in order to create long-term sustainable growth,” Blackford said. “The goal is to enable iRhythm to be a glo…

iRhythm CEO considers costs on the path to profitability

iRhythm’s Zio cardiac monitoring device [Image courtesy of iRhythm]

Fresh off positive reimbursement news for its Zio remote external electrocardiogram monitoring device, the CEO of iRhythm Technologies (NSDQ:IRTC) doesn’t just have revenue on his mind.

iRhythm President and CEO Quentin Blackford — the former Dexcom COO who replaced Mike Coyle in September — said his company will need to keep costs under control as it grows to serve tens of millions and then hundreds of millions of patients in the years ahead.

“This means introducing things like automation where it’s possible, reconfiguring processes and streamlining systems and structures across the organization, as well as really rethinking how and where we do the work in this new remote environment that we’re proving can be so successful,” Blackford said today at the J.P. Morgan Healthcare Conference. “Ultimat…

AtriCure posts Street-beating Q3 results, maintains full-year outlook

AtriCure (NSDQ:ATRC) posted third-quarter results today that beat the consensus forecast on Wall Street and maintained its outlook for the full year.

The Mason, Ohio-based atrial fibrillation (AFib) technology developer reported profits of $97.1 million, or $2.11 per diluted share, on sales of $70.5 million for the three months ended Sept. 30.

Get the full story at our sister site, MassDevice.

AtriCure posts Street-beating Q3 results, maintains full-year outlook

AtriCure (NSDQ:ATRC) posted third-quarter results today that beat the consensus forecast on Wall Street and maintained its outlook for the full year.

The Mason, Ohio-based atrial fibrillation (AFib) technology developer reported profits of $97.1 million, or $2.11 per diluted share, on sales of $70.5 million for the three months ended Sept. 30.

Sales grew 28.7% compared with Q3 2020, during which time the company reported a net loss of $0.11 per diluted share.

Adjusted to exclude one-time items, the company reported a net loss per share of $0.23, beating the Street by $0.09, where analysts were looking for a net loss per share of $0.32 on sales of $68.55.million.

“Our results were driven by strong growth across key product lines, including the addition of new Cryo Nerve Block and Hybrid AF Therapy accounts, providing further validation of demand across our business,” AtriCure President and CEO Michael Carrel said in a news release. “We feel encoura…

Medtronic points to study showing that multi-hour AFib increases stroke risks

Medtronic (NYSE:MDT) announced today that a study using its continuous rhythm monitoring device showed AFib’s relationship with ischemic stroke.

Fridley, Minnesota-based Medtronic’s data covers 466,635 patients included in the Optum unidentified electronic health record (EHR) and Medtronic CareLink databases. Findings were published online in JAMA Cardiology, according to a news release.

Of the large population of patients, 891 who had Medtronic cardiovascular implantable electronic devices (CIEDs) capable of continuous rhythm monitoring sustained both an ischemic stroke and received 120 day of continuous monitoring prior to that stroke. The study defined AFib exposure as lasting 5.5 hours or more on any given day.

In total, 76.5% of those subjects had no AFib meeting the threshold over either 30-day period observed (1 to 30 days prior and 91 to 120 prior to the event), while 16% had at least one day with 5.5 hours or more of AFib in both per…