Baxter Archives - Page 10 of 11 - Medical Design Sourcing

Baxter gains EUA for renal replacement tech for critically ill children

Baxter (NYSE:BAX) announced today that it received FDA emergency use authorization (EUA) for its HF20 Set and ST Set for continuous renal replacement therapy (CRRT).

Under EUA, the HF20 Set can deliver CRRT to treat patients of low weight (8-20 kg) and low blood volume who can’t tolerate a larger extracorporeal circuit volume in an acute care environment during the COVID-19 pandemic. The ST Set now has authorization for providing CRRT for patients in acute care settings too, and both can be used with the Prismaflex or PrisMax control units, according to a news release.

Deerfield, Ill.-based Baxter’s HF20 Set offers low extracorporeal blood volumes (58 mL) and the PolyArylEtherSulfone (PAES) filter membrane, while the ST Set includes three sizes for patient-based variation and Baxter’s proprietary AN69 membrane for adsorbing toxins.

The company said a limited initial shipment of the HF20 Set and ST Set will be available in the U.S. ̶…

DTW Podcast: 10 ways medtech is finding its footing amid COVID-19

When COVID-19 set upon the U.S. in March, medtech executives had a month at most to tell Wall Street analysts how the pandemic had hit the industry’s largest companies. We heard about short-term hits in revenues, procedures and employee headcounts, but uncertainty clearly ruled the day.

Over the past few weeks, medtech executives from several leading companies reported back to analysts with a full quarter under their belt. To be sure, no one can claim to hold a full grasp on this crisis, but a survey of the calls reveals steps and adjustments that companies are taking to thrive beyond the pandemic.

In this podcast, we’ll list our Top 10.

Don’t miss an episode! Subscribe to DeviceTalks Weekly on your podcast players. It’s available on Apple Podcasts, Spotify and other podcast channels.

DeviceTalks by MassDevice · Ten ways medtech companies are finding their footing during the pandemic

MedTech 100 roundup: Industry hits another mid-pandemic high

Despite a minor regression week-over-week, the medtech industry’s stocks hit another milestone as the COVID-19 rebound remains in progress.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.01 points at the end of last week (July 31). Overall, medtech stocks saw a -0.3% increase from the 89.29-point total at the same time a week prior (July 24).

On July 30, the index reached 90.37 points, marking its highest point since that pre-pandemic high, with the previous mid-pandemic high (90.11) coming last week.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Meanwhile, the S&P 500 Index saw a 1.7% increase from July 24 to July 31, and the Dow Jones Index posted a -0.2% drop over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at …

DTW: What in the world will Thrive Earlier Detection do with $257 million?

In this week’s podcast, two executives from Thrive Earlier Detection explain how the “turbo-charged” diagnostics company intends to upend how, when and where cancer is diagnosed.

Dr. Isaac Kinde, co-founder and head of research and innovation, walks us through the company’s CancerSEEK test and how the company is marrying new technology with an innovative clinical approach. Meanwhile, CFO Isaac Ro, tells host Tom Salemi how the company closed on $257 million (hint: lots of Zoom) and why he left a career on Wall Street to join this innovative start-up.

Chris Newmarker, executive editor of life sciences at MassDevice, also counts down on the biggest newsmakers in this week’s MassDevice.

Don’t miss an episode! Subscribe to DeviceTalks Weekly on your podcast players. It’s available on Apple Podcasts, Spotify and other podcast channels.

DeviceTalks by MassDevice · What in the world will Thrive Earlier Detection do with $257 million?

The top 5 MassDevice stories of the week — July 31, 2020

The past week has seen a slew of Q2 earnings reports from medical device companies — and the picture overall hasn’t been pretty amid the COVID-19 pandemic.

Still, medtech CEOs during their earnings calls said they’re starting to see some signs of hospital procedures recovering a bit even as the southern U.S. deals with a coronavirus wave. Some of the top MassDevice stories this week actually involved companies providing more solutions to improve management of the pandemic.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. A few bright spots amid the COVID-19 financial toll

Dexcom (NSDQ:DXCM) proved to be one of the few bright spots among medtech Q2 earnings reports, blowing away the Wall Street consensus forecast as it successfully pivoted to making its continuous glucose monitors avail…

Baxter dips on missed Q2 projections

Baxter (NYSE:BAX) shares took a hit today on second-quarter financial results that came up short of the consensus forecast.

The Deerfield, Ill.-based company posted profits of $247 million, or 48¢ per share, on sales of $2.7 billion for the three months ended June 30, 2020, for a 21.1% bottom-line slide) on a sales decline of -4.1%.

Adjusted to exclude one-time items, earnings per share were 64¢, 7¢ behind Wall Street, where analysts were looking for sales of $2.9 billion.

Baxter’s acute therapies segment received a boost in demand amid the COVID-19 pandemic, along with its renal care and clinical nutrition GBUs, helping to offset some of the financial downturns over the past several months.

However, the pandemic’s impact resulted in declines in the company’s medication delivery, pharmaceuticals, and advanced surgery businesses, which Baxter attributes to lower rates of hospital admissions and declines of elective surgeries in th…

Baxter, Ayogo to provide digital health support for people with kidney failure

Baxter (NYSE:BAX) and Ayogo Health Inc. announced today that they are expanding their partnership to support people with kidney disease.

The partnership between Deerfield, Ill.-based Baxter and Vancouver, B.C.-based Ayogo will combine the latter’s LifePlan behavior-based digital platform with Baxter’s renal care expertise to build mobile apps and digital solutions to support kidney failure patients, according to a news release.

The companies plan to build a new mobile platform for patients using Baxter’s Sharesource remote monitoring platform with automated peritoneal dialysis therapy.

Additionally, Baxter made an equity investment in Ayogo in exchange for minority interest in the company, although financial details of the agreement were not disclosed.

“As a leader in renal care innovation and pioneer in digital health solutions for patients with kidney failure, our collaboration with Ayogo allows us to provide healthcare profess…

FDA clears new Baxter bone graft substitute

Image from Baxter

Baxter (NYSE:BAX) announced today that it received FDA clearance for its Altapore Shape bioactive bone graft for bone growth and fusion.

Deerfield, Ill.-based Baxter’s Altapore Shape is its latest addition to its bone graft substitute product line, designed to enhance bone growth and aid in achieving fusion, leading to reduced pain and other improved clinical outcomes for patients, according to a news release.

Altapore Shape is used as a standalone bone graft substitute or as an autograft extender to fill bony voids or gaps in the skeletal system caused by trauma, including those within the pelvis, extremities and the posterolateral spine. The bone graft resorbs and is replaced with bone during the healing process, enhancing bone growth with optimized porosity that promotes earlier vascularization.

Baxter offers the system in four configurations, with three cylinders of …

B,. Braun, Baxter, CareStream, Green Hills affected by Ripple20 cyber vulnerabilities

The U.S. Cybersecurity and Infrastructure Security Agency (CISA) said it is aware of vulnerabilities affecting Treck IP stack implications for embedded systems.

Known as Ripple20, the vulnerabilities allow a remote attacker to exploit and take control of an affected system, according to the CISA statement.

Among the affected companies were B. Braun, Baxter (NYSE:BAX), Green Hills Software and CareStream. CISA encouraged affected users and administrators to review the affected products for additional information and mitigations, as well as to update to the latest stable version of the Treck IP stack software.

B. Braun issued a statement saying that it is aware of the notification from CISA, sharing that the vulnerabilities exist in the third-party software used for network communication in its Outlook 400ES safety infusion pump system.

The company said it received 24 patches from Treck to resolve vulnerabilities, determining that 20 patche…

Baxter systems flagged for cybersecurity vulnerabilities

The U.S. Department of Homeland Security released notices citing cyber vulnerabilities with four devices made by Baxter (NYSE:BAX).

Included among the devices listed by DHS were Baxter’s PrismaFlex/PrisMax devices, its ExactaMix, its Phoenix hemodialysis delivery system and its Sigma Spectrum infusion pumps.

All four notices included warnings regarding the devices’ Cleartext transmission of sensitive information. According to the notices, the affected devices do not implement data-in-transit encryption when configured to send treatment data to a patient data management system (PDMS), which could make the devices vulnerable to an attacker seeking to observe sensitive data.

The PrismaFlex system for acute kidney injury and the PrisMax system for delivering continuous renal replacement therapy and therapeutic plasma exchange both had vulnerabilities with improper authentication, meaning the devices could be susceptible to an attacker modifying t…

Baxter wins CE Mark for EVO IQ syringe system

Baxter (NYSE:BAX) announced that it received regulatory approval in Europe and Australia for its Evo IQ syringe infusion system.

With CE Mark approval in Europe and a nod from Australia’s Therapeutic Goods Administration (TGA), the company expects hospitals in the United Kingdom, Ireland, Greece, Australia and New Zealand to be among the first to receive the new system.

Get the full story at our sister site, MassDevice.

Baxter wins CE Mark for EVO IQ syringe system

Baxter (NYSE:BAX) announced that it received regulatory approval in Europe and Australia for its Evo IQ syringe infusion system.

With CE Mark approval in Europe and a nod from Australia’s Therapeutic Goods Administration (TGA), the company expects hospitals in the United Kingdom, Ireland, Greece, Australia and New Zealand to be among the first to receive the new system.

Baxter’s Evo IQ system delivers small volumes of medications and other fluids in a controlled manner as part of the Evo IQ infusion platform, a suite of smart pumps designed for patients’ specific needs. With Baxter’s web-based Dose IQ safety software and wireless IQ Enterprise connectivity suite, the device is designed around preventing harmful infusion programming errors and facilitating compliance and efficiency for clinicians.

According to a news release, Baxter expects Evo IQ to be available in select markets in Europe, Australia and New Zealand next month. Read more