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How Medtronic and Avail will accelerate stroke care innovation

Avail Medsystems’ consoles connect neurosurgeons with Medtronic Neurovascular sales reps, commercial teams and stroke experts. [Image courtesy of Avail]

Medtronic Neurovascular and Avail Medsystems have signed an agreement to use Avail’s operating room consoles during stroke procedures, the leaders of both businesses told Medical Design & Outsourcing this week.

Medtronic will pay to place several hundred Avail consoles around the U.S. in the next few years. The deal enables the medtech giant to connect virtually with neurosurgeons, Medtronic Neurovascular President Dan Volz said in an interview. (Read more details of the deal at our sister publication MassDevice.)

Avail’s consoles provide live-streaming video, audio and imaging data between surgeons in operating rooms and experts elsewhere. They can watch on a laptop or tablet and offer real-time feedback.

Medtronic Neurovascular goes remote with Avail Medsystems deal

Avail Medsystems’ consoles connect neurosurgeons with Medtronic Neurovascular sales reps, commercial teams and stroke experts. [Image courtesy of Avail]Medtronic (NYSE:MDT) Neurovascular will pay to use hundreds of Avail Medsystems consoles in operating rooms across the country under a first-of-its-kind deal, leaders of both businesses told MassDevice this week.

The Medtronic unit will use Avail’s operating room telepresence technology to connect virtually with neurosurgeons and other care providers as they treat stroke patients, Medtronic Neurovascular President Dan Volz said in an interview. The deal covers several hundred Avail consoles, he said.

Avail Medsystems’ consoles send video, audio and imaging data to remote users of the Avail app on laptops and tablets. [Image courtesy of Avail]Additionally, the consoles will let surgeons confer with other physicians and experts over the system. Avail’s system offers two-way visual, audio and data…

Nuwellis can’t get a quorum for shareholder vote

Nuwellis (Nasdaq:NUWE) announced today that it convened and adjourned its meeting of stockholders due to a failure to reach a quorum.

The fluid overload treatment developer held the meeting on Dec. 7 without any business conducted due to the lack of quorum.

Minneapolis-based Nuwellis develops the Aquadex SmartFlow system for ultrafiltration therapy. The company describes Aquadex SmartFlow as a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload).

Nuwellis said its quorum consists of one-third of the outstanding shares entitled to vote. Fewer than one-third of outstanding shares attended, either virtually or represented by proxy, at the special meeting. During the period of adjournment, the company intends to continue soliciting votes from its stockholders. This occurs with respect to the proposals set forth in its proxy statement.

Only Nuwellis stockholders as of the record date (Oct…

FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals

neffy. [Image from ARS Pharmaceuticals]

ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine.

The offering covers the emergency treatment of severe type I allergic reactions in children and adults weighing 30 kg (66 pounds) or more. The company set an anticipated target action date of mid-2023 for its PDUFA (Prescription Drug User Fee Act).

ARS Pharmaceutical developed neffy with the Neurelis Intravail transmucosal absorption enhancement technology. Intravail enhances drug absorption through the nasal mucosa. This enables the noninvasive delivery of protein, peptide and small-molecule drugs.

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

Teleflex warns on some intra-aortic balloon pumps

Teleflex (NYSE:TFX) subsidiary Arrow initiated a voluntary field safety corrective action for some intra-aortic balloon pump devices.

According to a safety notice issued in Europe, the devices have a potential issue around short battery run times. The devices can be powered by either an AC power source or battery power. As of Oct. 11, 2022, Teleflex received no reports of patient injuries or deaths related to the issue.

Affected devices include the Arrow AutoCAT 2 and Arrow AC3 Optimus pumps.

The affected pumps have an expected duration after a full charge of 90 minutes. However, some users reported short battery run times that included loss of power during use.

Additionally, the device design includes alarms. Those alert users of 20, 10 and 5 minutes of battery life remaining. In the past two years, Teleflex received one complaint of the unit shutting off without the alarms going off. It received 13 complaints reporting missing alarms where users…

Edwards Lifesciences CEO to step down next year

Edwards Lifesciences (NYSE:EW) announced today that Michael A. Mussallem, chair and CEO, intends to retire next year.

Mussallem, 70, informed the board of his decision to retire in connection with Edwards’ annual meeting of stockholders on May 11, 2023.

At that meeting, Mussallem intends to stand for election as non-executive chair of the Edwards Board. The company’s succession plan tabbed Bernard Zovighian to succeed him as CEO. Zovighian currently serves as corporate VP and GM of Edwards’ transcatheter mitral and tricuspid therapies (TMTT) business.

Zovighian takes over as president, effective Jan. 1, until he becomes CEO in May. Edwards plans for him and Mussallem, along with the board and executive leadership team, to work closely to ensure a smooth transition.

“It has been a special honor and privilege to lead our team at Edwards Lifesciences for more than 20 years in their immense contributions to helping and advancin…

FDA clears Dexcom G7 next-gen CGM

[Image from Dexcom]Dexcom (Nasdaq:DXCM) announced today that the FDA cleared the next-generation Dexcom G7 continuous glucose monitoring (CGM) system.

FDA clearance for the highly anticipated device covers people with all types of diabetes aged two years and older.

San Diego-based Dexcom’s device features a 60% size reduction from the previous generation, the G6. It offers a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past).

G7 provides more information in one place with personalized insights, extended-wear design and more. It features a simple wear experience, starting with unscrewing a cap. The user then puts the sensor on their body and pushes a button. The device is then turned on and can be paired with a smartphone.

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

Johnson Matthey opens medical nitinol facility in Mexico

Johnson Matthey today opened a brand new nitinol facility in Mexicali, Mexico for its Medical Device Components business.

The facility has 40,000 square feet of manufacturing space for nitinol sheet and tubing, double the capacity of the company’s previous location in San Jose, California. The newly constructed plant in Mexicali is the world’s only low-cost-country manufacturer of nitinol sheet and tube, Johnson Matthey said in a news release.

The site is scheduled to be fully operational by 2023.

Johnson Matthey said the new facility will give its customers increased capacity for device launches, optimized cost, enhanced quality assurance and dependable deliveries with shorter leadtimes. Additionally, Mexicali’s proximity to Jonson Matthey’s San Diego facility will allow for consistency with JM’s company values, business processes and management oversight, the company said.

“With 35 years of nitinol experience, this is a n…

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…

Corvia randomizes first patient in atrial shunt trial

[Image from Corvia Medical]Corvia Medical announced that it randomized the first patient in its Responder-HF global confirmatory trial of its atrial shunt.

Tewksbury, Massachusetts-based Corvia designed its shunt for heart failure patients with preserved (HFpEF) or mildly reduced (HFmrEF) ejection fraction.

Dr. Scott Lilly and Dr. Rami Kahwash enrolled and randomized the first patient at the Ohio State University Wexner Medical Center. In a news release, Lilly noted that atrial shunt therapy could “represent significant clinical benefit” for millions of patients.

“Despite ongoing pharmaceutical advances, the treatment of HFpEF remains challenging, and multiple therapies are needed to treat such a heterogenous disease,” said Kahwash. “We are pleased to offer access to a novel treatment option that has the potential to relieve our patients’ breathlessness and improve their quality of life.”

About Responder-HF

C…

5 Black medtech startup founders to know

Sanxtuary MD founder and CEO Dr. Amber Robins [Photo courtesy of gBETA]

Five startup founders are preparing their pitches for the gBETA Medtech Black Founders Accelerator’s virtual showcase next week.

Their companies are the eighth cohort for the gBETA Medtech Accelerator, which focused on Black founders for its fall 2022 program. The five companies received $10,000 grants, plus coaching, mentorship and other support over the course of the seven-week program.

The gBETA Medtech Accelerator is a program of startup accelerator Gener8tor and the University Enterprise Labs (UEL) business incubator in St. Paul, Minnesota, with mentorship support from Mayo Clinic, the University of Minnesota and Medical Alley Association. The program’s sponsors inculde Boston Scientific and Fox Rothschild. UEL and Gener8tor also get support through a cooperative agreement with BARDA DRIVe.

You can RSVP for the virt…

ChroniSense Medical wins FDA clearance for wearable patient monitor

The Polso remote patient monitor. [Image courtesy of ChroniSense Medical]ChroniSense Medical announced that its Polso remote patient monitoring system received FDA 510(k) clearance.

Polso received initial indications for monitoring blood oxygen saturation (SpO2), pulse rate and respiration rate.

Yokneam, Israel-based ChroniSense designed Polso to combine a monitor, mobile app and cloud-based platform. The medical-grade, wrist-worn vital sign monitor pairs with a mobile app for patients. The cloud-based platform for clinicians monitors in-life patient data.

“FDA clearance is a significant milestone towards the commercialization of Polso Connect and towards creating a new model in chronic care management,” said ChroniSense Medical CEO Bridget Ross. “With six out of 10 adults in the U.S. living with a chronic condition and over $1.1 trillion in direct healthcare costs annually1, there is a serious need for an easy-to-use, medical grade, remo…