MassDevice Archives - Page 218 of 587 - Medical Design Sourcing

Verily receives $1B investment led by Alphabet, promotes president to corner office

Google’s (NSDQ:GOOGL) Verily announced today that it received a $1 billion investment led by parent company Alphabet.

South San Francisco, California-based Verily plans to use the funds to expand its businesses focused on precision health. New capital will go toward a variety of its core initiatives.

Those include real-world evidence generation, healthcare data, research and care and the underlying technology, Verily said. The company will also consider further investment in strategic partnerships, global business development and potential acquisitions.

During a recent DeviceTalks Weekly podcast, investor and advisor Steve Oesterle, formerly of Medtronic, said he was still all in on Google and Verily. Technology is the only logical way to deliver healthcare to a massive, fast-growing population, he said. “Whoever has the most data and knows how to aggregate it and analyze it is going to win in healthcare.”

Leadership changes at Verily

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Japanese Hospital to initiate program with Asensus Surgical’s Senhance surgical robot

[Image from Asensus Surgical]Asensus Surgical (NYSE:ASXC) announced today that a hospital in Japan agreed to lease and utilize its Senhance surgical robot system.

Saiseikai Shiga Hospital in Ritto, Japan, agreed to a deal with Research Triangle Park, North Carolina-based Asensus.

The hospital will use the Asensus Senhance surgical system. The first-of-its-kind digital laparoscopic surgical robot uses augmented intelligence to perform procedures through machine learning. It features surgical assurance through haptic feedback, eye-tracking camera control, and 3D visualization.

Asensus said in a news release that Senhance is the first platform to offer 3mm instruments. They are the smallest instrument available in the world on a robotic surgical platform.

“We are very excited to be partnering with Saiseikai Shiga Hospital, one of the leading hospitals in Japan. While the system will be initially utilized in the General Surgery Department, we look forwar…

MedAlliance enrolls first patient in study of drug-eluting balloon for treating erectile dysfunction

MedAlliance announced today that it enrolled the first patient in a trial for its drug-eluting ballon in treating erectile dysfunction.

Geneva, Switzerland-based MedAlliance said an 82-year-old Taiwanese man enrolled in the initial trial. It will evaluate the Selution SLR sirolimus-eluting balloon for the treatment of erectile dysfunction (ED).

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

FDA warns of clip lock issue on some Abbott MitraClip heart valves

The MitraClip TMVR device [Image courtesy of Abbott]The FDA alerted healthcare providers about potential malfunctions with the Abbott (NYSE:ABT) MitraClip clip delivery systems.

On Sept. 8, Abbott issued an urgent medical device correction. It informed providers of an increased rate of reports of clip lock malfunctions. Users observed malfunctions both before and after clip deployment.

The FDA notice said the events appear to occur in approximately 1.3% of MitraClip procedures. Users observed such events with all device models.

Abbott designed MitraClip to treat mitral regurgitation (MR). In the event of a clip lock malfunction, patients are at risk of ineffective treatment for MR. It also increases the potential need for additional interventions, leading to risks such as bleeding, implant complications and lengthened procedure times.

The majority of reported malfunctions for MitraClip were not associated with adverse patient outcomes. Based on avail…

Samsung unveils new V7 ultrasound system

The Samsung V7 ultrasound system [Image courtesy of Samsung]Samsung today introduced its V7 ultrasound system, having recently picked up FDA 510(k) clearance for commercial use.

Danvers, Massachusetts–based Boston Imaging — the U.S. headquarters of Samsung’s digital radiography and ultrasound business — unveiled the platform. It designed the ultrasound system to provide a range of clinical applications, improving the patient and user experience.

“There is a continued demand on imaging professionals to deliver high-quality results in an efficient amount of time, without compromising patient care,” said David Legg, VP, Head of Boston Imaging. “We’re proud to help address this by supplying one more solution that helps make clinical assessments effortless and treatment precise.”

V7 includes enhanced image clarity through Samsung Crystal Architecture. It features the combination of CrystalBeam beamforming, CrystalLive image processing and S-Vue Single Crys…

CISA warns on cybersecurity vulnerabilities for certain Baxter infusion pumps

The U.S. Cybersecurity and Infrastructure Security Agency (CISA) today issued a warning on some Baxter (NYSE:BAX) infusion pumps.

Sigma and Baxter Spectrum infusion pumps are included in a CISA notice over remotely exploitable vulnerabilities. Those vulnerabilities include: missing description of sensitive data, use of externally controlled format string and missing authentication for critical functions.

The successful exploitation of the vulnerabilities could allow access to sensitive data. It could also result in the alteration of system configuration.

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

Philips faces legal scrutiny in France over respiratory devices recall

Problems continue to mount around the massive respiratory device recall at Royal Philips (NYSE:PHG).

Reuters reported today that French prosecutors have opened a preliminary investigation into the recall, citing a text message from a Paris public prosecutor’s office spokesperson.

In the U.S., the FDA and federal prosecutors are increasingly scrutinizing how Philips has handled the deadly recall, which involves more than a million CPAPs, ventilators and other respiratory devices. Philips has effectively been removed from the respiratory devices market for a year as it deals with the recall. Roy Jakobs, the company’s Connected Care chief businesses leader who has been in charge of the recall, is slated to become CEO next month.

Respiratory device problems stem from polyester-based polyurethane sound abatement foam that could break down. Foam particles could enter a device’s air pathway and cause a range of potential health problems and toxic, carcino…

First patient enrolled in Zoll trial for supersaturated oxygen therapy in heart attack patients

[Image from Zoll]Zoll Medical announced that the first patient enrolled in its AMIHOT III post-approval study for its TherOx supersaturated oxygen (SSO2) therapy.

Chelmsford, Massachusetts-based Zoll’s trial will evaluate TherOx for treating the most severe form of heart attack: left anterior descending (LAD) ST-elevation myocardial infarction (STEMI). TherOx is an FDA-approved therapy shown to reduce the size of damaged tissue following percutaneous coronary intervention (PCI).

Zoll’s SSO2 therapy delivers a high concentration of dissolved oxygen directly to damaged heart muscle immediately after stenting. TherOx is indicated for patients who suffer LAD STEMI treated within six hours of symptom onset.

The first patient was treated with SSO2 therapy at WakeMed Health & Hospitals in North Carolina. AMIHOT III will further validate the benefits of TherOx over standard of care along. Aside from safety and effectiveness, additional endpoints inc…

Accuray partners with Switzerland innovation hub

Accuray (Nasdaq:ARAY) announced that it partnered with Genolier Innovation Hub to establish a new approach to improving patient care.

Genolier, a subsidiary of Aevis Victoria, will unite companies from medtech, pharma and biosciences, as well as physicians and scientists. The goal is to bring medical and technological advances to patients faster. The Hub is expected to open in early 2024. It will be located at the Genolier Healthcare Campus in Genolier, Switzerland.

The facility will offer workspaces to support simulation-based training, plus radiation therapy systems for training. It will also feature R&D and demonstration offerings and meeting rooms for seminars, workshops and events.

Under the partnership, Accuray will leverage the Hub as a global training center. There, customers can obtain hands-on training and learn about radiation therapy techniques with Accuray’s CyberKnife and Radixact systems.

“We are proud to lead the ra…

Lyra Therapeutics enrolls first patient in Phase 3 chronic rhinosinusitis trial

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 (Nasdaq:LYRA) announced today that it enrolled the first patient in its Phase 3 Enlighten II clinical trial.

Enlighten II is evaluating the company’s LYR-210 in adult patients with chronic rhinosinusitis (CRS). Lyra’s proprietary XTreo platform delivers LYR-210.

Watertown, Massachusetts-based Lyra designed the proprietary XTreo platform for precise, sustained and local delivery. The platform is comprised of a flexible mesh capable of taking a high payload of a drug.

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

Attune Medical wins FDA IDE nod to evaluate ensoETM in radiofrequency ablation procedures

[Image from Attune Medical]Attune Medical announced today that the FDA granted investigational device exemption (IDE) to study the company’s ensoETM.

Chicago-based Attune designed ensoETM to reduce esophageal thermal injury during cardiac radiofrequency (RF) ablation procedures. The IMPACT II study is underway in Europe and already enrolled nearly 20 patients.

Attune said in a news release that the single-use thermal regulating device is placed in the esophagus and connected to an external heat exchange unit. This creates a closed-loop system for heat transfer to increase or decrease patient temperature. Placement in the esophagus allows for highly efficient heat transfer due to proximity to blood flow from the heart and vessels.

The company said ensoETM’s internal placement doesn’t impede patient access during surgery. It also allows for gastric decompression and the administration of fluids and medications. Attune designed it to simplif…

Elizabeth Holmes seeks new trial after key witness expresses remorse over testimony

Theranos founder Elizabeth Holmes (center) arrives at federal court in San Jose, California on Aug. 31, 2021. [Photo by David Paul Morris/Bloomberg via Getty Images]Former Theranos CEO Elizabeth Holmes is seeking a new trial as one of the key witnesses in her federal fraud trial expressed regret for their testimony.

Holmes filed a motion on September 6 requesting a new trial after former Theranos lab director Adam Rosendorff went to her house to make amends about his testimony against her in her federal fraud trial, Business Insider reports.

After more than 50 hours and seven days of deliberations in January following Holmes’ federal fraud trial, a jury found her guilty on four counts of wire fraud and conspiracy to commit wire fraud related to allegations that she intentionally lied to investors about Theranos’ blood testing technology.

Rosendorff testified in October last year and was a witness for the prosecution. During the trial, he said he…