MassDevice Archives - Page 409 of 587 - Medical Design Sourcing

Levita Magnetics announces first magnetic robot-assisted surgeries

Levita Magnetics announced today that it performed the first procedures with its robot-assisted surgical platform.

Menlo Park, Calif.-based Levita’s newest system, the Levita Robotic Platform, was used by Dr. Ignacio Robles in a reduced-incision laparoscopic cholecystectomy (gallbladder removal) at Clínica INDISA in Santiago, Chile, as part of a clinical study of the platform.

According to a news release, Levita designed the new platform to deliver the clinical benefits of the company’s first commercial product, the Levita Magnetic surgical system, which includes less pain, faster recovery and fewer scars.

The company said it intends to use the platform to improve visualization, maintain surgeon control of instruments and increase hospital efficiency with fewer assistive personnel required for the procedure. The design specifically targets high-volume ambulatory or same-day discharge abdominal surgeries.

Robles said the first procedure…

Outset Medical CFO to leave, interim replacement named

Outset Medical (NSDQ:OM) announced that CFO Rebecca Chambers will step down and Nabeel Ahmed will take over in an interim capacity.

San Jose, Calif.-based Outset said in a news release that Chambers will depart to pursue other opportunities, effective on July 16, 2021. Ahmed, current VP of finance at the company, will assume the role once Chambers leaves.

Outset also announced that preliminary unaudited net revenue for the second quarter of 2021 is expected to be in the range of $24.5 million to $25 million, marking growth of 109% to 113% over the second quarter of 2020.

“On behalf of myself and the board of directors, we want to thank Rebecca for her contributions to Outset. She has been a key contributor to our success to date, and we wish her the best in her future endeavors,” Outset president & CEO Leslie Trigg said in the release. “Today, Outset is in a stronger position both financially and operationally than ever before. We are very pleased wi…

Eurofins launches COVID-19 testing network to facilitate European travel

Eurofins announced today that it opened a network of about 500 COVID-19 testing centers across Europe to help facilitate summer travel.

Luxembourg-based Eurofins’ network covers major traveling hubs to provide testing accessibility in locations ranging from supermarkets to business parks and residential areas, too.

According to a news release, the company’s 500-center network is already developed, with plans to establish around 1,000 testing centers this month. The company also operates mobile testing centers to further increase availability and access, with those centers available to municipal authorities to reduce pressure on existing centers with added sampling capacity.

Each mobile collection center can process up to 200 PCR tests per day. Eurofins already launched the mobile service in Belgium, France and Germany.

Lazurite to unveil ArthroFree wireless arthroscopic camera system, appoint new execs

Lazurite (formerly Indago) announced that it will present its ArthroFree wireless arthroscopic camera system next week.

Cleveland-based Lazurite will unveil the ArthroFree platform at the annual meeting of the American Orthopedic Society for Sport Medicine (AOSSM) and the Arthroscopy Association of North America (AANA) at Music City Center in Nashville, Tenn., from July 7 to July 11.

ArthroFree uses Lazurite’s proprietary low heat, high-intensity Meridiem light engine technology with advanced camera, battery and wireless transmission technologies to create what Lazurite touts as the world’s first fully wireless, minimally invasive camera system for the operating room.

The system does not currently hold FDA clearance and is not approved for human use, with Lazurite planning to submit its FDA 510(k) premarket notification in late 2021. Should all go to plan, the company expects to receive approval and commence the product launch in the first ha…

DarioHealth touts data for diabetes management platform

DarioHealth (NSDQ:DRIO) recently presented data supporting its artificial intelligence (AI)-powered diabetes management platform.

New York-based Dario’s research examined users who were given access to a new product experience designed to drive better health habits and behaviors through its AI-driven personalization engine.

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

Intuition Robotics thinks companion robots could help doctors follow older patients at home

Intuition Robotics today announced that it has expanded its AI-drive companion robot capabilities to provide care for older adults at home.

Boston-based Intuition Robotics designed the ElliQ empathetic companion robot to help increase patient engagement and improve the patient experience to give primary care providers continuous data and insights for early detection and intervention of clinical conditions.

The empathetic digital companion robot is designed to curb loneliness and social isolation in older adults.

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

EchoNous raises $60M for AI-guided ultrasound

EchoNous announced that it raised $60 million to go toward the launch of its flagship AI-guided Kosmos ultrasound device.

Redmond, Wash.-based EchoNous received the investment from Kennedy Lewis Investment Management, with the funding combining senior secured debt and equity to build on the support of KKR, EchoNous’ principal investor since 2015, according to a news release.

The company said the proceeds will help propel the commercial launch of the Kosmos AI-guided point-of-care ultrasound system designed to provide diagnostic-quality imaging on par with larger, less portable and more expensive imaging machines.

Kosmos enables systolic heart function assessment and EchoNous touts it as the only handheld point-of-care ultrasound system to offer continuous-wave Doppler capability. Additionally, the company said Kosmos is the only product of its size and in its category to meet HIPAA requirements for data collection, storage and transmission.

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Could people one day get pacemakers that dissolve into the body?

Wireless, battery-free, fully implantable pacemakers made of bioresorbable components could represent the future of temporary pacing technology.

The device, seen here mounted on the heart, could benefit post-cardiac surgery patients. [Image courtesy of Rogers Lab/Northwestern University]Flexible, dissolvable electronics could soon pave the way for temporary pacemaker wearers to avert the risks associated with surgical procedures from initial implantation to the removal of the device once its job is done.

Northwestern and George Washington universities have developed what they say is the first-ever transient pacemaker that’s not only wireless, battery-free and fully implantable — but also disappears when it’s no longer needed. Its biocompatible components can naturally absorb into the body over five to seven weeks eliminating the need for surgical removal.

In a study published on June 28 in Nature Biotechnology, researchers demonstrated the device’s efficacy…

Windtree Therapeutics appoints senior VP, general counsel

Drug- and medtech developer Windtree Therapeutics (NSDQ:WINT) today said it appointed Diane Carman as senior VP and general counsel.

Carman will report directly to president and CEO Craig Fraser. She has more than two decades of experience working in life sciences and other highly regulated industries.

“We are delighted to welcome Diane to the Windtree team in her new role as general counsel,” Fraser said in a news release. “She is a talented and experienced executive with in-depth knowledge of pharmaceutical development companies and our clinical and business development operations. Her decades of legal and executive experience will be instrumental as we advance our multiple late-stage clinical candidates and grow the business.”

Prior to joining the company, Carman served as general counsel and secretary at Vitara Biomedical. She has also held numerous leadership roles at Helius Medical Technologies, Ablynx and Gamesa Technology.…

Teva initiates U.S. recall of Topotecan metastatic ovarian cancer injection treatment

Teva Pharmaceuticals (NYSE:TEVA) initiated a voluntary recall of a lot of its Topotecan injection 4mg/4mL (1mg/mL) in the U.S.

The voluntary recall came as a result of a complaint received from a pharmacy after a single glass particle was observed inside one vial. Following further examination of the complaint sample, two other particulates were found and identified as one grey silicone particle and one translucent, colorless cotton fiber.

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

FDA revokes EUAs for certain respirators, decontamination systems after increased N95 access

The FDA issued a briefing confirming the revoking of emergency use authorizations (EUAs) for certain respirators and decontamination systems.

EUAs for all non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators, including disposable respirators like KN95s, along with decontamination and bioburden reduction systems, were all revoked, having been issued amid the COVID-19 pandemic.

According to an FDA release, the actions were consistent with the updated CDC recommendations for healthcare facilities to not use crisis capacity strategies and promptly return to conventional practices. Manufacturers of decontamination and bioburden reduction systems requested — and the FDA agreed to — the revocation of their EUAs, effective June 30.

NIOSH approved more than 875 respirator models or configurations since the beginning of the pandemic. The EUA revocations apply to all non-NIOSH approved, disposable facepiece respirator mod…

Philips treats first patient will 3D intracardiac echocardiography catheter

Royal Philips (NYSE:PHG) announced today that it treated the first patient with its real-time, 3D intracardiac echocardiography (ICE) catheter.

Dr. Mohamad Adnan Alkhouli performed a left atrial appendage occlusion (LAAO) procedure with Philips’ VeriSight Pro platform at the Minneapolis-based Mayo Clinic.

The real-time 3D Philips intracardiac echocardiography catheter, when combined with Philips’ premium cardiology ultrasound system (EPIQ CVx), offers 2D and 3D live image guidance for a wide range of procedures for structural heart disease and electrophysiology, according to a news release.

VeriSight Pro uses the same ultrasound technology used in standard live ultrasound imaging for heart disease and electrophysiology but miniaturized to fit on the tip of a 1.98 mm-diameter catheter that can be navigated to the patient’s heart through their vasculature. The procedure does not require general anesthesia.

The platform is available…