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Baxter warns on some infusion pumps due to potential false alarms

The Spectrum IQ infusion system. [Image from Baxter]Baxter (NYSE:BAX) issued an urgent medical device correction for some Spectrum V8 and Spectrum IV infusion pumps in the U.S.

Affected pumps in the U.S. and Puerto Rico received upgrades to software versions v8.01.01 and v9.02.01. Baxter issued the correction due to an increase in reported false upstream occlusion alarms following the software upgrades. The Deerfield, Illinois-based company plans to revert the software to the previous version on all affected pumps.

Baxter’s notice said that the upgraded software may cause an alarm for upstream occlusion when one isn’t present. That can lead to an interruption or delay of therapy, potentially causing serious adverse health consequences for users.

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

Abbott is pulling its Trifecta valves off the market

The Trifecta GT heart valve [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced today that it is withdrawing its Trifecta family of heart valves from worldwide markets.

The market withdrawal comes more than five months after Abbott and the FDA told health providers that the valves could deteriorate early.

In a statement shared with MassDevice, the company said: “Abbott has decided to withdraw and discontinue its Trifecta family of valves to focus on its next-generation tissue valves that maximize possibilities for lifetime management of valvular heart disease.”

In a letter dated today and shared by the FDA, the company told U.S. health providers that it would collect its unused consigned inventory and assist in the returns of any customer-owned inventory.

The company added in its shared statement: “Abbott is initiating inventory-related activities worldwide for unused Trifecta and Trif…

Alarming results and some good news from MDR and IVDR survey of notified bodies

[Image via Adobe Stock]

By Annette Van Raamsdonk and Evangeline Loh, Emergo by UL

The European Commission (EC) posted a July 25 update on the current state of Medical Devices Regulation (2017/745 MDR) and In Vitro Diagnostics Devices Regulation (2017/746 IVDR) applications.

The data collected was from a recent survey instrument intended to monitor and analyze the availability of devices on the EU market.

Study on medical devices and Notified Body survey instrument

The study was led by Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting. The study started in December 2022 and will end in 2025.

The survey instrument to collect the most recent data on certificates issued and the number of applications received was shared with the Notified Bodies on April 3, 2023, and concluded May 5, 2023.

The collected data have been compared with data…

Augmedics to acquire digital health assets from Surgalign auction

Augmedics announced today that it successfully bid for the digital health assets of Surgalign and Holo Surgical following an auction.

Surgalign conducted the court-supervised marketing and sale process following its Chapter 11 bankruptcy filing in June. It conducted the auction process in accordance with bidding procedures approved by the U.S. Bankruptcy Court for the Southern District of Texas, Houston Division.

According to Surgalign, Augmedics bid for the digital health assets with a cash purchase price of $900,000. It also includes the assumption of certain liabilities.

The Chicago-based augmented reality-based surgical navigation technology developer says the purchase strengthens its portfolio with IP and other digital health assets. Augmedics expects the sale to close pending Bankruptcy Court approval at a hearing set for Aug. 8.

This news follows last month’s announcement of an $82.5 million fundraising round for Augmedics.

“We…

Robotic hand uses low-cost touch sensors instead of vision

The four-fingered robotic hand has 16 touch sensors. [Image via UCSD]

Engineers at the University of California San Diego developed a new approach allowing a robotic hand to rotate objects solely through touch.

The UCSD method enables a robotic hand to do so without relying on vision. Using their technique, the engineers built a hand that can smoothly rotate a range of objects, including small toys and cans. It can rotate fruits and vegetables without squishing them as well, accomplishing its tasks using only information based on touch.

According to UCSD, the team believes the work could help develop robots that can manipulate objects in the dark.

To build the system, the team attached 16 touch sensors (which cost about $12 apiece) to the palm and fingers of a four-fingered robotic hand. These sensors detect whether an object is touching the robotic hand. The low-cost, low-resolution touch sensors…

Inspire Medical appoints former AppliedVR exec as chief medical officer

New Inspire Medical Chief Medical Officer Dr. Charisse Sparks. [Image from Charisse Sparks on LinkedIn]Inspire Medical Systems announced today that it named Dr. Charisse Sparks as its new chief medical officer (CMO).

Minneapolis-based Inspire made Sparks’ appointment effective on July 27. As CMO, she serves as a member of the sleep apnea treatment maker’s executive leadership teams. Sparks’ responsibilities include leading medical and clinical affairs, reporting to President and CEO Tim Herbert.

The appointment of Sparks comes one week after the company named Carlton Weatherby as its new chief strategy officer.

“We are excited to add Dr. Sparks, a board-certified physician with extensive business and leadership experience, to our executive team,” said Herbert. “Inspire has long partnered with leading ear, nose, and throat surgeons, and sleep physicians, as part of our medical advisory boards. In her role as our chief medical officer,…

Anteris Technologies touts first successful implant of DurAVR THV in valve-in-valve procedure

The DurAVR THV. [Image from Anteris Technologies]Anteris Technologies announced today that surgeons used its DurAVR heart valve for the first time in a valve-in-valve (ViV) procedure.

Brisbane, Australia-based Anteris — which has U.S. operations in Minneapolis — designed TurAVR THV as a new class of biomimetic heart valve. The company says it’s the world’s only balloon-expandable, single-piece transcatheter aortic valve shaped to mimic a native human aortic valve’s performance.

Balloon-expandable delivery enables precise alignment with the heart’s native commissures, achieving desired valve positioning.

The first ViV use of the valve came as part of Health Canada’s Special Access Program (SAP). Dr. Anita Asgar, co-director of the structural heart program at the Institut de Cardiologie de Montreal, made the SAP request. She wanted to use the Anteris valve for a patient with a failing valve and short frame height. According to An…

Henry Schein, Medpod collaborate to launch Medpac portable telediagnostics system

[Image courtesy of Henry Schein and Medpod]Henry Schein (Nasdaq: HSIC) + announced today that it launched the Medpac solution along with Medpod.

Melville, New York-based Henry Schein and Medpod collaborated to develop Medpac as a lightweight, portable telediagnostic offering. It enables healthcare providers to offer comprehensive professional care regardless of location. The companies say it bridges the gap between remote telemedicine consultations and in-person office visits.

Henry Schein and Medpod have a long-standing relationship, having collaborated on telehealth with Uber Health in 2019. The company distributes the Medpod MobileDoc platform.

“We are excited to join forces with Medpod Inc. to introduce Medpac, which will further our efforts to help health care providers deliver exceptional care to patients in any setting,” said Todd Stack, GM of medical solutions at Henry Schein. “Medpac features Medpod’s pion…

Balancing on a tightrope, pharma’s generative AI journey straddles fear and FOMO

[vetal1983/Adobe Stock]

Pharma and biotech companies have had a spectrum of responses to the surge in generative artificial intelligence (AI). A recent Washington Post article describes an unnamed biotech firm that banned employees from using OpenAI’s ChatGPT despite its capability to bolster productivity given concerns over potential data leaks. At the same time, the burgeoning AI landscape have created a fear of missing out, or FOMO, among businesses, including the pharma sector. “There’s this fear of missing out that I think is driving everybody to do something,” said Scott Snyder, chief digital officer at Eversana. On a tightrope of fear and FOMO, the pharmaceutical industry’s journey with generative AI continues with some companies taking more of a wait-and-see approach and others forging ahead with the technology to, for instance, discovery novel compounds.

Eversana is among those that ar…

Boston Scientific ramps up Farapulse manufacturing with new site

The Farapulse pulsed-field ablation system’s Farawave catheter (pictured) uses an energy field generated by the Farastar to treat atrial fibrillation. [Image courtesy of Boston Scientific]

Boston Scientific plans to increase production of its Farapulse pulsed-field ablation (PFA) system with a second pulse generator manufacturing site.

“Demand for the platform far exceeds our ability to supply thus far,” Boston Scientific Chair and CEO Mike Mahoney said on yesterday’s earnings call.

He soon after shared that the device developer “just recently received GMED approval for a manufacturing approval to actually manufacture this in Minnesota.”

Paris-based GMED is a notified body designated by France for conformity assessment under the EU Medical Devices Regulation (MDR).

Farapulse Inc. secured CE mark approval for the system before being acquired by Boston Sci…

Eversana partners with AWS to accelerate generative AI in pharma

Life sciences commercial services company Eversana is one of the latest to throw its hat into the generative AI ring. Tapping a partnership with Amazon Web Services (AWS), Everasana is focusing on developing generative AI technologies in the pharmaceutical industry.

Also this month, the startup Synthetica Bio announced it would use generative AI to boost drug discovery innovation while Nvidia announced it would invest $50 million in the biotech Recursion to support its AI drug discovery efforts. Earlier this year, Nvidia debuted a cloud service for generative AI in drug discovery known as BioNemo.

Eversana’s approach to generative AI in pharma

Eversana aims to ‘pharmatise’ AI. The company’s chief digital officer Scott Snyder explains: “When we talk about pharmatising, it’s overlaying all of the unique needs, requirements, and goals of pharma, but layering it on to the innovation capability of generative AI.”…

Data supports portfolio of HeartFlow precision coronary care solutions

HeartFlow today announced positive results from clinical studies evaluating its portfolio of coronary care technologies.

Mountain View, California-based HeartFlow said the studies demonstrate the accuracy, utility and efficiency of its portfolio. The RevealPlaque, Decode and Smart-CT studies looked at the company’s coronary computed tomography angiography (CCTA)-based systems.

HeartFlow presented results at the Society of Cardiovascular Computed Tomography (SCCT) Conference in Boston.

The company’s RoadMap Analysis non-invasively helps to identify stenoses in the coronary arteries. Its FFRCT Analysis assesses coronary blood flow and the Plaque Analysis characterizes and quantifies coronary atherosclerosis. Together, the comprehensive solution offers data not currently available with traditional non-invasive diagnostic tools. HeartFlow says this allows clinicians to see the full picture of the patients’ coronary artery disea…