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Medtronic, BioIntelliSense partner on distribution of wearable patient monitoring device

The BioButton from BioIntelliSense

Medtronic (NYSE:MDT) announced today that it partnered with BioIntelliSense on distribution rights for the BioButton device.

BioButton, a multi-paremter wearable for continuous, connected monitoring, measures up to 1,440 vital sign measurements per day. Its measurements include skin temperature, respiratory rate at rest, and heart rate at rest.

The device, combined with advanced analytics, helps clinicians to better detect early signs of patient deterioration. Conversely, it can help to identify stable patients who may be candidates for earlier hospital discharge.

BioIntelliSense’s rechargeable device also offers configurable acute and post-acute modes, according to a news release. These modes help to continuously monitor patients transitioning from higher to lower acuity settings.

The partnership enables the Medtronic patient monitoring business to offer access to a medical grade device that provides conti…

JenaValve raises $100M Series C for TAVR tech

JenaValve Technology announced today that it completed the initial closing of a $100 million Series C financing round.

Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems.

The company intends to use proceeds from the financing to complete its FDA investigational device exemption (IDE) premarket approval (PMA) study to garner FDA approval for the Trilogy heart valve system. JenaValve designed Trilogy for high surgical risk patients with symptomatic, severe aortic regurgitation (AR).

Additionally, the company plans to use the proceeds to bolster its real-world data development initiatives in Europe. JenaValve also plans to expand its worldwide manufacturing capabilities.

“JenaValve is committed to becoming the first and only FDA-approved transfemoral transcatheter valve system indicated for symptomatic, severe aortic regurgitation, addressing an estimated multi-billion-dol…

Inari Medical launches trial to assess ClotTriever system in deep vein thrombosis

Inari Medical (Nasdaq:NARI) announced that it will conduct a trial for its ClotTriever system for iliofemoral deep vein thrombosis (DVT).

The Irvine, California-based company’s Defiance trial will compare ClotTriever to anticoagulation only for patients with iliofemoral DVT.

Defiance will enroll 300 patients across up to 60 centers around the world. It represents Inari’s second randomized controlled trial, running in parallel to the Peerless trial. Peerless compares the FlowTriever to catheter-directed thrombolytics in pulmonary embolism.

According to an Inari news release, the primary endpoint is a hierarchical composite of treatment failure and PTS severity at 6 months.

Dr. Xhorlina Marko, co-principal investigator and interventional radiologist at Beaumont Health, said in the release that Defiance is the first randomized controlled trial that compares mechanical thrombectomy to anticoagulation for the treatment of DVT.

Dr. St…

Philips to pay $4.2M in DOJ settlement over patient monitoring device modifications

[Image from Philips’ website]Philips (NYSE:PHG) today agreed to pay approximately $4.2 million to resolve allegations of substituting key components of a monitoring device.

The company settled with the U.S. Department of Justice (DOJ) over claims that it substituted the components of its Intellivue MP2 mobile patient monitoring device that it sold to military purchasers without rectifying the device for military airworthiness.

A Philips spokesperson said that, among the company’s discussions with DOJ, it reached the final stages of settlement discussions regarding three separate matters, all of which are related to its connected care portfolio. This is the first of the three settlements to have been announced.

Despite their relation to the connected care portfolio, none of the three settlement discussions are related to the June 2021 Philips Respironics recall, for which the company is also in talks with DOJ.

Acc…

How Pfizer’s alliance with Morgan State University prioritizes diversity in vaccine development

Pfizer (NYSE:PFE) and Morgan State University have unveiled a novel program known as the Doctor of Public Health (DrPH) Fellowship in Vaccines Medical Development. A central aim of the program is to foster diversity in vaccine development.

In particular, the two-year DrPH program aims to increase the number of minority scholar-practitioners involved in vaccine development. In addition, the initiative will offer fellows training and networking opportunities to pave the way for leadership roles in the biopharma industry.

The program officially launched today.

Ronika Alexander-Parrish

Ronika Alexander-Parrish, a clinical scientist at Pfizer and founding director of the DrPH Fellowship, said the idea came out of brainstorming that began in the early days of the COVID-19 pandemic, which highlighted healthcare inequity.

Alexander-Parrish said the company’s leadership embraced her vis…

Hamilton Medical’s ventilator recall is Class I

The FDA issued a notice labeling a recall of the Hamilton Medical Hamilton-C6 intensive care ventilator as Class I, the most serious kind.

Hamilton Medical initiated the recall for its ventilator on June 27, 2022. The recall is due to a hardware issue with the ventilator’s status indicator board. It covers 497 devices distributed between Aug. 31, 2017, and May 20, 2022. To date, Hamilton received 128 complaints related to the issue, with no deaths or injuries reported.

According to the FDA notice, customer complaints revealed that the Hamilton-C6 ventilator’s status indicator board may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator’s main board.

Water ingress may cause the ventilator to have a technical fault. This would revert the device to a safety ventilation mode or revert to an ambient state. In such a state, the patient breathes ambient room air with no assistance or support from the machine. Read more

Mayo Clinic develops AI childbirth risk prediction tool for women in labor

Dr. Abimbola Famuyide is a Mayo Clinic OB-GYN studying AI algorithms for childbirth. [Photo courtesy of Mayo Clinic]

Mayo Clinic researchers are using AI algorithms to calculate childbirth risk while women are in labor in an effort to reduce the rate of cesarean delivery and complications.

The machine learning algorithms — a type of device known as Software as a Medical Device (SaMD), where the software is the device rather than a mechanical device — analyze patterns of changes for women in labor.

ADVICE: How to pass the patent eligibility test for Software as a Medical Device

“This is the first step to using algorithms in providing powerful guidance to physicians and midwives as they make critical decisions during the labor process,” senior author Dr. Abimbola Famuyide said in a news release. “Once validated with further research, we believe the algorithm will work in real time,…

Report: BD’s Bard unit to pay $4.8M in hernia mesh lawsuit

The C.R. Bard unit of BD (NYSE:BDX) was ordered to pay $4.8 million in a lawsuit related to its hernia mesh, Reuters reports.

The news agency said the company must pay nearly $5 million in a lawsuit brought by a Hawaii man who said he suffered serious complications from the implanted hernia repair mesh. BD will appeal the decision, a spokesperson told Reuters.

Paul Trevino and his wife, Earlynn, alleged in a 2018 lawsuit that the Ventralex hernia repair mesh from BD’s Bard business dug into his tissue, causing pain and inflammation while eventually leading to required corrective surgery, according to the report.

A Rhode Island jury handed down the verdict following a month-long trial, Reuters said. BD faces more than 30,000 lawsuits of a similar kind related to hernia mesh devices.

Mesh devices have been the subject of legal challenges over the years, proving to potentially be one of medtech’s greatest modern failures. Pelvic mesh prod…

Philips Respironics has a new serious recall for certain ventilators

Philips (NYSE:PHG) has a new FDA Class I recall for its ventilators, adding to recall issues that have plagued the company for a year.

The FDA issued a notice alerting patients, caregivers and providers that certain Philips Respironics bi-level positive airway pressure (BiPAP or BPAP) machines may contain a plastic contaminated with a non-compatible material. If such plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). It may also cause the machine to fail and stop working suddenly during use.

FDA said the potential risks of inhaling VOCs include headaches, dizziness, irritation in the eyes, nose, respiratory tract and skin, hypersensitivity reactions, nausea or vomiting and toxic and cancer-causing effects. If the plastic causes the machine to fail and stop working suddenly, it may lead to serious injury or death.

At this stage, the FDA is not aware of any reports of serious injury or deat…

FDA approves ‘first-in-market’ autoinjector for treating prolonged seizures

[Image from Rafa]Rafa Laboratories announced today that it received FDA approval for its 10mg Midazolam autoinjector for treating status epilepticus (prolonged seizures).

Jerusalem-based Rafa developed the autoinjector through cooperation with the U.S. Department of Defense’s (D0D) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).

Rafa’s Midazolam 10mg autoinjector received FDA indication for the treatment of status epilepticus, or prolonged seizures, in adults. This means the new autoinjector can be used to treat seizures resulting from nerve agent exposure. JPEO-CBRND determined that the autoinjector improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA), the diazepam autoinjector.

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

Second Sight Medical merges with Nano Precision Medical, rebrands as Vivani Medical

Second Sight Medical (Nasdaq:EYES) announced today that it completed its merger with Nano Precision Medical and rebranded.

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

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

Medtronic completes Affera acquisition

Medtronic (NYSE:MDT) announced today that it completed its acquisition of cardiac mapping and ablation technology developer Affera.

Newton, Massachusetts-based Affera designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, including a differentiated, focal pulsed-field ablation platform for treating cardiac arrhythmias like AFib.

In January, Medtronic announced an agreement to acquire Affera, with CEO Geoff Martha labeling the deal as a nearly $1 billion transaction at the J.P. Morgan Healthcare Conference, adding that it includes a $250 million contingent consideration.

The company had been a strategic investor in Affera through its minority investment portfolio. Prior to the acquisition, Medtronic held a 3% stake in the company.

According to a news release, the acquisition expands Medtronic’s cardiac ablation portfolio. The portfolio will now include its first-ever cardiac m…